Medical devices

Too few Notified Bodies in Europe despite the increase in CE marking applications. Analysis of the 2021-2025 figures and outlook up to 2028.

Introduction: the paradox of growing demand versus limited supply

Since the MDR and IVDR came into effect, all medical device manufacturers are required to go through Notified Bodies (NB). Each device or device family must be certified compliant with the regulation to be placed on the European market. Yet, the number of designated bodies remains insufficient to handle the volume of applications.

Regulatory context: MDR, IVDR and the role of Notified Bodies

— Regulation (EU) 2017/745 (MDR), which entered into force on 26 May 2021, replaces the old directives.
— Regulation (EU) 2017/746 (IVDR) for in vitro devices entered into force in 2022.
— Notified Bodies are the entities authorised to carry out conformity assessments, particularly for higher class devices, and are also responsible for evaluating technical documentation, auditing quality systems, etc.

Some key figures

According to MedTech Europe, the Medical Device and In-Vitro sector in Europe accounts for:

• Approximately 38,000 companies
• More than 500,000 devices in circulation in 2025 (of which at least 80% are still under the European Directives 93/42/EEC and 98/79/EC)

The transition to MDR & IVDR

In February 2025, according to data published by the European Commission, the 51 officially designated NBs were responsible for processing around 28,500 certification applications. By the same date, more than 12,000 certificates have been granted, representing 43% of all applications.

What you also need to know:

• On average, the certification process for a single application takes between 13 and 18 months to complete
• Incomplete applications prolong the certification process even further
• Applications can be refused and must therefore be resubmitted

The breaking point: why the lack of NBs represents a systemic risk

— Bottlenecks: existing NBs are overwhelmed by the volume of applications and their resources (expertise, auditors) are limited.
— Increased regulatory complexity: the MDR imposes stricter requirements (clinical, post-market surveillance, enhanced documentation) compared with the former directives, increasing the workload per application.
— Incomplete or poorly prepared applications: these cause significant delays for both NBs and manufacturers.
— Risk of device shortages: if manufacturers fail to obtain certification in time, market access may be delayed, leading to potential shortages in the EU market. One of the key reasons for extending the transitional periods is precisely to avoid such disruptions.
— Mounting time pressure: with the final certification deadline set for 2028, the available transition period is becoming increasingly limited.

Outlook: what to expect by 2028?

Outlook 1: Based on the rate of NB designations between 2022 and 2025, it is expected that the number could rise from 51 currently to 85 NBs by the end of 2027 and more than 100 in 2028. However, this depends heavily on political will, national investments, and accreditation capacities.

Outlook 2: Continuing the observed trends since 2022, the total number of applications is expected to reach at least 114,000. However, this figure is not fully representative and should be considerably higher as approximately 400,000 devices out of the 500,000 currently on the market must comply with the regulation. And this is despite the possibility of grouping by “device family” (otherwise 1 device = 1 application).

Outlook 3: Based on the current certification rate, it is estimated that 95,000 certificates will be issued in 2028. This still falls short of the 114,000 potential applications in the best-case scenario.

Projected outcomes: If the number of 104 NBs is indeed reached by 2028 and the number of certificates issued is also achieved, this represents 919 certifications per NB. Is this viable?

Impacts for manufacturers and PRRCs/QARA teams

For those responsible for Regulatory Affairs, the pressure is palpable. The various constraints mentioned above (time, budget, regulatory requirements, etc.) make the task particularly challenging because:

— Selecting an NB becomes a strategic challenge: availability, deadlines, expertise, pricing, specialisation by device type.
— Proactive planning is essential: start preparing files well in advance, take advantage of preliminary audits, ensure documentation is complete and compliant.
— Risk of launch delays: even when a product is ready, it must wait for NB review before it can enter the market.
— Occasional reliance on foreign NBs (costs, logistics).
— importance of a stable partnership with the NB: essential for planning surveillance audits, renewals, scope changes, etc.

Despite the best efforts of all parties involved, the complexity of regulatory requirements and the glaring lack of NBs make the task difficult. Key industry players, including the NBs themselves, regularly call on the authorities to highlight structural shortcomings and warn them of the risks of bottlenecks and market shortages.

What can be done to improve the situation?

In the above-mentioned context, there is no miracle solution. If Europe wants to avoid a severe shortage of medical devices, it must act quickly, notably by considering the following proposals:

— Encourage Member States to promote and support the designation of additional NBs.
— Harmonise and simplify certain steps of the evaluation process to reduce the administrative burden (by reviewing certain requirements).
— Strengthen the training of MDR/IVDR expert auditors to increase the pool of available skills.
— Ensure the documentary quality of manufacturers to avoid unnecessary iterations (with clear and precise explanations of what is required).

— Establish a legal response time for NBs?
— Promote collaboration between NBs, national agencies and industry associations to better distribute the workload.

Conclusion: the countdown has begun

The shortage of Notified Bodies in Europe remains one of the major obstacles to a smooth transition to a market that is fully compliant with MDR/IVDR regulations. For both manufacturers and PRRCs/QARA teams, this reality requires a rigorous, forward-looking, and resilient strategy. If the designation of new NBs progresses, it must be accompanied by a real increase in capacity and improved efficiency to prevent widespread bottlenecks by 2028.

Latest figures updated October 2025:

• Notified Bodies for EU Regulation 2017/745 on Medical Devices: 51
• Notified Bodies for EU Regulation 2017/746  on In Vitro Devices: 19

Sources and references

1. European Commission – Study supporting the monitoring of the availability of medical devices on the EU market, 2025.
   https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_
2. MedTech Europe – The European Medical Technology Industry in figures, 2025.
3. European Commission – NANDO (New Approach Notified and Designated Organisations) Information System.
   https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies

AbroadLink takes part in the 4th TEAM PRRC Congress in Rome, reaffirming its support for PRRCs and medical device compliance across Europe.

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What is TEAM-PRRC and what does it do?

TEAM-PRRC is a European non-profit organisation founded in 2020, dedicated to the profession of “Person Responsible for Regulatory Compliance” (PRRC), as described in Article 15 of Regulation (EU) 2017/745 “MDR” and Regulation (EU) 2017/746 “IVDR”.
Here is what you need to know about its role:

• Its goal is to support PRRCs (Persons Responsible for Regulatory Compliance) in their duties by offering them a platform for exchange, best practices, and useful tools.
• It seeks to represent the interests of PRRCs before European authorities, notified bodies, and stakeholders in the medical device and in vitro diagnostics industry.
• It promotes networking, continuous training, the dissemination of best practice documents, and greater consistency in interpreting regulatory obligations in a context where PRRCs often navigate “uncertain waters” due to complex requirements.
• PRRCs play a vital role in ensuring the compliance of medical devices and IVDs in Europe, through tasks such as verifying compliance, maintaining up-to-date technical documentation, and post-market surveillance.

In short, TEAM-PRRC acts as a central point of contact, a professional network, and a support community for the professionals responsible for regulatory compliance. For companies in the medical sector, this means being able to exchange, anticipate, and better manage deadlines and constraints.

Presentation of the event in Rome

The 2025 edition of the annual TEAM-PRRC congress took place in Rome, Italy, over two days of conferences. Here are the key figures and highlights:

Key figures

• Location: Rome, Italy.
• Duration: 2 days of conferences and exchanges.
• Participants: Around 100 professionals from the PRRC, medical device, and diagnostics sector.
• Speakers: Around twenty experts were invited to share their experience, regulatory insights, and perspectives on future developments.
• Exhibitors: 6 exhibiting organisations (including AbroadLink) presented their specific solutions or services.

Themes and content

This edition was focused on the theme of potential upcoming legislative changes and how these may affect the role of PRRCs in their functions and responsibilities.
Specifically, the topics covered included:

• Possible developments in medical and diagnostics regulation in Europe;
• The impact of these developments on the internal organisation of medical device manufacturers and importers;
• The increased role of PRRCs in terms of compliance management, interaction with notified bodies, technical documentation, and post-market surveillance.
• Opportunities for networking, exchange, and best practices among PRRCs from different European countries.

Highlight: the anniversary evening

The gala dinner marked the association's five-year anniversary in a friendly yet professional atmosphere, strengthening connections between members, speakers, and exhibitors. The president of the association, Elem Ayne, highlighted the importance of the TEAM-PRRC community for the sector. This social and networking dimension is a key element for anchoring the relevance of the association in the long term.

Why AbroadLink sponsors TEAM-PRRC and why we participate in its congresses every year

Each year, AbroadLink participates in the TEAM-PRRC congress as a sponsor and exhibitor. This choice reflects our commitment to maintaining close ties with the key players in regulatory compliance and better understanding the challenges faced by PRRCs.

We regularly collaborate with these professionals to help them manage the linguistic aspect of their documentation, whether it be IFUs, labelling, technical files, or post-market reports. Our services are aligned with the ISO 13485 standard to ensure the quality and compliance of translations, an essential point in the field of medical devices.

By supporting TEAM-PRRC, we also help promote best practices and the improvement of compliance processes in a complex regulatory environment.

Conclusion

PRRC professionals operate in one of the most demanding European regulatory environments, facing complex legislation, strict deadlines, and challenging interactions with notified bodies. The role is crucial, but also often fraught with challenges. The TEAM-PRRC association meets this need for support, exchange, and guidance for these key players.

As a translation and localisation company specialising in the medical sector, AbroadLink fully plays its role by sponsoring and participating in each edition of the TEAM-PRRC congress. We know that these events are much more than just conferences: they are times of sharing, learning, and network building, which directly benefit PRRCs and, by extension, their companies and patients.

While waiting for the next congress to be held in Prague from 29 to 30 October 2026, we will continue our collaboration with Team-PRRC. Furthermore, after the great success of the webinar “Translation under MDR & IVDR: What a PRRC Should Know”, we will organise new sessions in the near future. Please feel free to comment on the topics you would like us to address.

To keep up with our news and events, follow our LinkedIn page and subscribe to our newsletter through this link.

Discover the latest European regulatory developments (2025/1234) on e-IFUs and their impact on the translation of medical device user manuals. Manufacturers, PRRCs and QARA professionals: everything you need to know to maintain compliance.

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1. What is an e-IFU and what is the reason behind this regulatory change?

Definition: e-IFUs (electronic Instructions for Use) are digital versions of the user manuals provided with medical devices.

Objectives of the transition: to modernise access to information, streamline document updates, and reduce environmental impact.

Regulatory context: Implementing Regulation (EU) 2021/2226 defines the conditions under which a manufacturer can provide IFUs in electronic form under the MDR (Regulation (EU) 2017/745).

Recent revision: Regulation (EU) 2025/1234, adopted on 25 June 2025, amends certain provisions of Implementing Regulation 2021/2226 on electronic instructions for use of medical devices.

2. Which medical devices fall within the scope of the e-IFU regulations?

Under Regulation (EU) 2021/2226, only certain devices intended for professional use can provide e-IFUs in place of paper versions. These include implantable devices, active implantable devices, fixed devices, accessories, and devices that display instructions via an integrated system.

The text also stipulates that the user can obtain a paper version on request, for safety or accessibility reasons.

With the 2025 revision (Regulation 2025/1234), the scope has been broadened, allowing devices intended for professional use to provide e-IFUs, even if they do not fall into the previously listed categories.

The European Commission clarifies this extension in a communication, stating: “healthcare professionals will be able to receive instructions for use of medical devices in electronic format, rather than solely on paper” (with the possibility of requesting a paper version).

In other words, all medical devices intended for professional use become eligible for e-IFUs, and manufacturers can provide the IFU in electronic form for these devices.

However, the extension does not require that all devices must necessarily transition to e-IFUs. For the time being, it is an authorised option, not an obligation.

In any case, it is important to ensure that technical and regulatory requirements are met. For each device, it is necessary to ensure:
1. Its intended use (professional vs. non-professional).
2. Its ability to meet requirements for accessibility, version control, language, and traceability.
3. The possibility of providing a paper version on request.

3. Summary of recent legal updates on e-IFUs (2025)

In June 2025, the Commission adopted Regulation (EU) 2025/1234, amending Implementing Regulation 2021/2226 to adapt the e-IFU framework to technological developments and feedback from professionals.

This reform lifts some of the limitations related to Annex XVI (certain listed non-medical devices) and broadens the use of e-IFUs to include all devices intended for professional use.

The Commission also published a communication highlighting that this measure aims to “simplify the instructions for use of medical devices” and promote the digitalisation of healthcare systems.

Before the regulation was adopted, a public consultation was launched at the beginning of 2025 to gather the views of manufacturers and professionals on the extension of e-IFUs.

Furthermore, some key industry players, such as MedTech Europe, called for the widespread adoption of e-IFUs for all devices for professional use.

4. What does the regulation say about the translation of e-IFUs?

The MDR requires that instructions and information, including IFUs, be provided in the languages required by the Member State in which the device is placed on the market.

The European Commission has published a document entitled “Overview of language requirements for manufacturers of medical devices”, listing the languages officially required by each country for instructions for use and accompanying documents.

In practice, this means that for an e-IFU, the electronic version must be available in the languages required by the target markets, with the same level of compliance as the paper version.

Any modification or update to a translated e-IFU must comply with the same validation, version control and traceability procedures as the original version.

5. What role do PRRCs and QARA professionals play in ensuring compliance with these requirements?

The PRRC (Person Responsible for Regulatory Compliance) must ensure that electronic versions (and their translations) meet MDR requirements, particularly in terms of accessibility, safety, updates and traceability. The role of the PRRC is defined in the MDR and its guidance documents (see MDCG guidance on Article 15).

QARA teams must integrate processes for managing digital versions, ensure linguistic validation, coordinate updates with specialised translators, and ensure consistency across all language versions.

It is essential that PRRCs and QARA teams implement documented procedures covering the e-IFU lifecycle, including creation, translation, validation, publication, and withdrawal or modification.

6. What specific changes will this bring for translation services?

Integration into a document management system (DMS) or a computer-assisted translation (CAT) tool is almost essential to manage versions, translation memories, approved glossaries, and ensure terminological consistency.

Translators themselves must specialise in the medical/medical device field, use regulatory glossaries, follow harmonised terminology, and understand compliance requirements.

In a frequently changing documentation environment, involving regulatory updates, safety alerts, etc., responsiveness is of critical importance: updated versions must be distributed quickly, whether in paper or digital format.

In this sense, language service providers and translators are strategic partners. They must be able to respond quickly and provide technical solutions to streamline document updates.

7. How can you ensure the linguistic compliance of e-IFUs?

Linguistic compliance of e-IFUs follows the same principles as for paper versions. To ensure maximum linguistic compliance of IFUs, it is strongly recommended to implement a translation + editing process by native experts specialised in the medical field, who are familiar with regulatory constraints.

Maintain a centralised, validated multilingual glossary, including the device's technical terminology.

Ensure version traceability: keep a record of all versions, modifications, and validations in each language.

Implement a structured quality control process, including consistency tests, verification of hyperlinks, and verification of cross-references across all language versions.

Document the e-IFU lifecycle in the technical file, including translation decisions, published versions, and justifications for updates.

8. Reliable sources to follow developments in e-IFU regulations

Eur-Lex: to access regulations, notably Implementing Regulation (EU) 2021/2226 and Regulation (EU) 2025/1234.

European Commission – healthcare/medical devices: “New Regulations” page on medical devices in Europe.

MDCG – guidance documents: the official page compiling MDCG-endorsed documents (guidances, Q&As, etc.).

Commission documents – “Overview of language requirements”: for language obligations by Member State.

Commission communications & news: notably “Commission simplifies instructions for use of medical devices” (25 June 2025) detailing e-IFU modifications.

Professional organisations (MedTech Europe, etc.): they publish position papers and analyses on the evolution of e-IFUs.

9. Quick checklist: are you ready for the new e-IFU requirements?

Are your e-IFUs available in electronic format, in accordance with the criteria set out in Implementing Regulation 2021/2226 and its 2025/1234 amendments?

Do your translations comply with the languages required by the target markets (cf. “Overview of language requirements”)?

Do you have a validated multilingual glossary shared across all languages?

Do you have a document management system or CAT tool in place to manage versions, updates, and translations?

Is the validation cycle (source → translation → editing → publication) documented and traceable?

Will post-market modifications or alerts be translated quickly and deployed in all relevant languages?

Does the technical file include a record of electronic versions and translations?

Are PRRCs and QARA teams trained in the specifics of e-IFUs (processes, responsibilities, compliance)?

AbroadLink takes part in the 2025 Rentrée du DM for the first time: expert translation and commitment to quality at the core of the medical device sector.

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AbroadLink at the Rentrée du DM in Besançon: a strategic debut in Bourgogne-Franche-Comté

For the first time, AbroadLink took part in the unmissable autumn event for the medical device sector: the Rentrée du DM, held in Besançon, at the heart of the Bourgogne-Franche-Comté region. This participation marks an important milestone in our commitment to supporting regulatory and quality professionals.

Understanding the Rentrée du DM: a flagship event for the medical sector in Bourgogne-Franche-Comté

The Rentrée du DM is an annual event that has, for the past 13 years, brought together key players in the medical device industry, including manufacturers, subcontractors, consultants, representatives of the competent authorities, PRRCs, and QARAs.

Led by Florent Guyon, this event, held in Besançon, spans two days of training aimed at sharing regulatory updates, best practices, and feedback, with a focus on cooperation and collective skill development.

Key figures and highlights of the 2025 edition in Besançon

The 2025 edition of the Rentrée du DM brought together over 450 participants, with numerous speakers taking to the stage for presentations and panel discussions. The diversity of topics covered, ranging from MDR/IVDR compliance to cybersecurity, underlined the event's importance for professionals across the sector.

The event also featured an exhibitor village with 30 stands, including Notified Bodies, consultants, and manufacturers.

This edition was also marked by the presence of the European Member of Parliament, Professor Laurent Castillo. A surgeon by profession, he represents France in the European Parliament and works, in particular, to ease the regulatory burdens imposed by European regulations, in order to give European medical devices a renewed competitive edge.

The role of translation in regulatory compliance (MDR, IVDR)

Language requirements form a key part of bringing medical devices to market. Translation is even considered one of the so-called “critical” tasks. The accurate translation of instructions for use, labels, or technical documentation is crucial for compliance with MDR/IVDR.

Why does AbroadLink work closely with PRRCs and QARAs?

Our participation in the Rentrée du DM reflects our commitment to supporting quality and regulatory managers (QARAs), as well as PRRCs, in their compliance efforts. As a translation service provider specialising in medical devices, we are instrumental in ensuring technical, clinical, and regulatory data are conveyed accurately and in compliance with regulations.

Our participation in the training underlines our commitment to the medical device sector, while allowing us to further develop our expertise to provide optimal support to manufacturers.

It also gave us an opportunity to engage with a variety of profiles, including regulatory and quality managers, consultants, and MedTech start-ups. Engaging with participants strengthened our understanding of the current challenges in the sector and validated the value of our services.

AbroadLink: a peripheral yet essential partner for manufacturers

Although we operate outside the manufacturing cycle, our translation services meet the demand of documentary compliance directly. As a peripheral yet strategic partner, our expertise helps medical device manufacturers comply with language obligations in their target countries.

This first participation strengthens our ability to support industry players in their multilingual compliance efforts. It also allows us to anticipate future needs in terms of documentation and technical communication.

Translation under the MDR and IVDR has become a pivotal issue for manufacturers of medical devices and in vitro diagnostics. This is precisely the topic discussed in the webinar “Translation Under the MDR and IVDR: What a PRRC/QARA Should Know!”, organised by Team-PRRC in collaboration with AbroadLink. This event brought together industry professionals to share practical insights on regulatory compliance and managing medical translations.

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Team-PRRC: a key partner for regulatory compliance

Team-PRRC is a European association that provides support to Persons Responsible for Regulatory Compliance (PRRC) as well as Quality and Regulatory Affairs (QARA) professionals. The organisation provides essential resources, training, and tools to help navigate the challenging landscape of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

AbroadLink extends its sincere thanks to Team-PRRC for this collaboration on the crucial topic of translating technical and regulatory documents.

An expert presentation on MDR/IVDR translation requirements

The webinar was hosted by Josh Gambin, founder and Chief Marketing Officer (CMO) of AbroadLink. With over 25 years of experience in scientific and medical translation, Josh Gambin offered valuable insights into:

• The role of translations in MDR/IVDR compliance
• Common errors that can lead to non-compliance
• Country-specific exceptions to consider
• The risks associated with AI and machine translation

These points provided participants with a clear understanding of the language requirements imposed by European regulations.

An event that brought together nearly 170 participants

The topic generated strong interest, with nearly 170 professionals from the medical device and in vitro diagnostics sector in attendance. This turnout reflects the rising importance of translation in ensuring regulatory compliance in Europe.

Quiz with a prize winner

An interactive quiz livened up the presentation by testing participants' knowledge. The winner, the fastest to correctly answer three questions on translation and MDR/IVDR regulations, received an Amazon gift card worth €100.

The event then continued with an engaging live Q&A session, allowing participants to further explore some of the points covered during the conference.

Prospects for future webinars

AbroadLink is proud to support PRRCs, QARA professionals, and all those involved in translations by helping to make regulatory requirements clearer and easier to navigate within the medical sector.

Building on the success of this event, AbroadLink, an ISO 13485-certified company, plans to organise further webinars on MDR/IVDR translation and topics related to medical and regulatory translation.

Suggestions for readers: Choose the topics for our upcoming webinars yourself! Share the topics you would like to see covered in future sessions in the comments.

Did you miss this webinar but are interested in its content?

To receive the webinar presentation, simply contact AbroadLink by email at: al@abroadlink.com.

After our rewarding experience last year in Málaga, AbroadLink Translations is excited to announce our sponsorship and participation at the TEAM-PRRC 4th Annual Summit 2025, taking place in Rome, Italy, on October 23–24, 2025.

This leading European regulatory affairs event has become a cornerstone for professionals working with medical devices, in vitro diagnostics, and MDR/IVDR compliance. It is where top experts gather to share knowledge, discuss challenges, and shape the future of regulatory frameworks in the Life Sciences industry.

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Who is TEAM-PRRC?

TEAM-PRRC (European Association of Person Responsible for Regulatory Compliance) is the main European association representing the Person Responsible for Regulatory Compliance (PRRC) role.

Introduced under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746), the PRRC ensures that manufacturers meet strict regulatory and quality requirements before placing products on the European market.

The mission of TEAM-PRRC is to:

• Support PRRCs across Europe with training, resources, and regulatory guidance.
• Promote compliance best practices in medical device and diagnostic companies.
• Strengthen patient safety through effective oversight and accountability.
• Create a network of experts for knowledge-sharing and collaboration.

Today, TEAM-PRRC has become the go-to community for regulatory compliance professionals in the EU medical device industry.

Why the TEAM-PRRC Summit 2025 in Rome is a Must-Attend Event

The TEAM-PRRC Annual Summit is recognized as one of the most important regulatory affairs conferences in Europe. Here’s why it stands out:

• Latest EU MDR/IVDR updates – Stay informed about new regulatory requirements and notified body expectations.
• European networking hub – Meet regulatory affairs experts, medical device manufacturers, consultants, and service providers.
• Practical insights – Interactive sessions provide hands-on solutions for navigating compliance challenges.
• Future-oriented topics – Discussions highlight how regulatory frameworks can foster innovation and safer healthcare solutions.

If you are involved in medical device compliance in Europe, this summit is a key opportunity to strengthen expertise and partnerships.

About AbroadLink Translations – Specialists in Life Sciences and Medical Devices

At AbroadLink Translations, we support Life Sciences companies with specialized translation services for medical devices, clinical trials, and regulatory documentation.

We are proud to hold three ISO certifications that guarantee quality and compliance:

• ISO 9001 – Quality Management Systems
• ISO 17100 – Translation Services
• ISO 13485 – Medical Devices Quality Management

With this expertise, we help:

• Medical device manufacturers comply with EU MDR/IVDR requirements across multilingual markets.
• Life Sciences companies expand globally with precise, industry-specific translations.
• Regulatory teams avoid risks through accurate, certified documentation translations.

By combining linguistic excellence and regulatory know-how, AbroadLink is the trusted partner for companies navigating compliance in Europe and beyond.

TEAM-PRRC 4th Annual Summit 2025 – Event Details

Location: Rome, Italy
Dates: October 23–24, 2025
Focus: EU MDR/IVDR compliance, medical device regulation, PRRC role

As a sponsor and exhibitor, AbroadLink Translations will be on site to connect with regulatory professionals, manufacturers, and innovators in the Life Sciences industry.

Following our successful participation at RAPS Euro Convergence 2025 in Brussels, we are eager to continue engaging in meaningful conversations, tackling regulatory challenges, and showcasing how our specialized regulatory translation solutions can support MDR/IVDR compliance and international growth.

Are you attending the TEAM-PRRC 4th Annual Summit in Rome? Visit us at our stand and let’s discuss how expert medical device translations can help your organization stay compliant, expand globally, and build safer healthcare systems.

At AbroadLink Translations, we are delighted to announce the successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications. This achievement demonstrates our unwavering commitment to quality, accuracy, and compliance in Life Sciences translations, particularly in the highly regulated field of medical devices in Europe.

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A Strong Commitment to Quality and Compliance

For companies operating in the Life Sciences and medical device sectors, precision in translation is not optional, it is essential. By renewing our three ISO certifications, we guarantee that our processes meet the highest international standards, giving our clients confidence in the safety, accuracy, and compliance of their multilingual documentation.

Our certifications include:

• ISO 9001 – Quality Management Systems: Ensures structured processes, continuous improvement, and customer satisfaction.
• ISO 17100 – Translation Services: The most demanding international standard for translation, requiring strict processes, qualified linguists, and a mandatory second review of every translation.
• ISO 13485 – Medical Devices Quality Management: Originally designed for medical device manufacturers, this certification guarantees that our translation processes meet the same stringent requirements applied to medical device companies under EU MDR (2017/745) and IVDR (2017/746).

Why ISO Certifications Matter in Medical Device Translations

In regulated industries such as medical devices, pharmaceuticals, and biotechnology, even a minor translation error can have serious implications for patient safety and regulatory compliance. That is why ISO-certified processes are vital.

• ISO 9001 ensures robust management and consistent quality.
• ISO 17100 guarantees every translation undergoes bilingual revision by a second professional, eliminating omissions or errors.
• ISO 13485 highlights our unique role as one of the few language service providers aligning with the same quality standards required of medical device manufacturers.

With these certifications, AbroadLink Translations offers Life Sciences companies across Europe and beyond the peace of mind that their critical documents such as clinical evaluations, IFUs, labeling, and regulatory submissions are handled with the highest precision.

A Trusted Translation Partner for the Life Sciences Industry

AbroadLink has years of expertise supporting medical device manufacturers, pharmaceutical companies, CROs, and research organizations. Our specialized team, combined with certified processes, helps clients:

• Stay compliant with EU MDR/IVDR requirements and global regulatory frameworks.
• Ensure linguistic accuracy and clarity across multilingual markets.
• Expand internationally with translations adapted to both scientific and cultural contexts.

By combining linguistic excellence with regulatory expertise, we position ourselves as a trusted partner for companies that need specialized Life Sciences translation services in Europe.

Looking Ahead

The successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications is a milestone in our journey to provide best-in-class translation services for the Life Sciences sector.

It reaffirms our mission: to help clients achieve regulatory compliance, international growth, and safer healthcare outcomes through accurate and reliable multilingual communication.

Beyond Certifications: Active Engagement in the Life Sciences Community

At AbroadLink, our commitment to the Life Sciences and regulatory affairs sector in Europe extends beyond our certified processes. We actively contribute to the industry by sponsoring, exhibiting, and sharing knowledge at leading international events:

• Sponsorship and exhibition at the TEAM-PRRC Annual Summit (Rome 2025).
• Our sales team for France will attend the training session at La Rentrée du DM in October 2025.
• Sponsorship and exhibition at RAPS Euro Convergence – Brussels 2025 and Lisbon 2026.
• Exhibition at MEDICA Düsseldorf 2024 and 2025, one of the world’s leading medical trade fairs.
• Hosting an upcoming webinar with TEAM-PRRC: “Translation Under the MDR and IVDR: What a PRRC Should Know!”.

These initiatives reflect our commitment to staying at the forefront of European regulatory affairs, while providing clients with not just translations, but specialized regulatory solutions that support compliance and innovation in healthcare.

Every year, the MEDICA trade fair in Düsseldorf brings together the most influential stakeholders in the global medical industry. From 17 to 20 November 2025, more than 5,000 exhibitors and 80,000 professional visitors from 165 different countries are expected to attend. It is the ideal opportunity to present your innovations, forge strategic partnerships and enhance your brand's visibility in the international market. MEDICA is much more than a trade fair... it is a powerful springboard for your international business strategy.

Exhibitor registrations closed on 3 March 2025, and requests are processed according to remaining availability. The trade fair covers a total area of over 115,000 m². To draw a comparison, this represents more than ten football pitches spread across the halls of the Messe Düsseldorf exhibition centre, making it one of the largest medical events in the world. The price of a stand varies according to its location, ranging from €298/m² to €329/m². Furthermore, there are supplementary fees, such as the mandatory Media Fee of €995, AUMA fees at €0.60/m² and waste management fees at €2.70/m². The standard minimum area is 12 m². As for visitors, tickets will be available a few months before the event, with a daily rate estimated at around €35, depending on the sales conditions.

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Preparing your stand well: location, furniture and essential equipment

The key to success lies in meticulous preparation. However, if it is your first time participating at Medica, your location will largely depend on luck since you will be randomly assigned a stand. In your second year, you will then have the chance to obtain the same location as the previous year, depending on your budget. Large companies that participate in the fair every year have an almost guaranteed location. Whenever possible, choose a strategic location, near the main aisles or close to the thematic pavilions, to maximize natural traffic and capture the attention of visitors already interested in your areas of expertise. Opt for a modular, ergonomic and luminous stand. A flexible design allows you to adapt the space to different formats, such as individual meetings, group presentations, technical demonstrations. Ergonomics improve the visitor experience and good lighting attracts the eye while highlighting the key elements of your offer.

To make your exhibition stand truly attractive, its layout should naturally encourage visitors to enter. A stand that is too closed off or isolated can discourage entry, as it creates a visual and psychological barrier. Conversely, an open, well-lit space structured with clearly identifiable areas encourages curiosity and exploration. The entrance to the stand should be clear and welcoming, with a direct view of key elements such as products or demonstrations. A warm, well-positioned and easily identifiable reception point creates a positive first contact. It guides visitors and puts them at ease from the moment they arrive. The demonstration area, for its part, plays an essential role: it allows you to showcase your products in real-life situations and capture attention with concrete demonstrations. It should be visible from outside the stand, while being harmoniously integrated into the visitor's journey. A discreetly partitioned private discussion area placed nearby offers a suitable setting for confidential or business exchanges with decision-makers. To enhance attractiveness, consider integrating welcoming elements such as plants, soft lighting, comfortable furniture and offering refreshments to provide visitors with an exclusive experience by creating a sense of privilege. This will make them feel valued and appreciated, which will obviously be beneficial for your company's image. The entire stand should reflect your visual identity while also creating a friendly and professional atmosphere.

Don't forget the essential equipment: screens, interactive kiosks and presentation materials. These tools add value to your content and reinforce your message. Screens can display videos of your products, customer testimonials or reports on practical use. Interactive kiosks allow visitors to independently explore your catalogue or services. Presentation materials allow visitors to better understand and remember your offer. All these elements will improve their experience and give them a professional image of your company.

By taking these actions, you will increase the attractiveness of your stand and consequently the attention of visitors. Don't forget to include furniture for your staff to rest on so that they are in the best condition during their presentations. Comfortable seating or a discreet break room can make a difference at an intense trade fair like MEDICA, keeping your team efficient and available throughout the event, especially during peak hours.

Anticipating logistics

The success of your presence depends on flawless logistical organisation. Book your hotels near Messe Düsseldorf very early as demand is high. Do not neglect the transport of your team either. From the city centre, you can opt for public transport. The trade fair is served by metro (line U78 or U79) as well as by bus (line 722). The good news is that all these transports are free throughout the duration of the trade fair upon presentation of your valid and personalised participant badge.

On-site visibility

Creating a striking visual identity for your stand is not limited to sticking a logo on a partition, it is a strategic staging of your brand. Play with the colours of your graphic charter and coordinate all your material, digital supports and furniture so they have a uniform look. This will create a brand identity in the minds of your visitors and your stand will be all the more impactful and memorable, in addition to exuding professional visual coherence.

Use LED lighting to highlight certain elements, such as your logo or product, by adjusting the orientation of the lights, dynamic lighting or even the colour of the spotlights. It is a good strategy to catch the eye of passers-by and capture the public's attention as much as possible.

Make sure to position your logo high so that it is noticeable even from a distance or in a dense crowd. This once again attracts the attention of visitors, especially if your stand is located among other exhibitors. Also multiply the visible panels on your stand. The idea is that your logo is identifiable from any angle to ensure immediate recognition of your stand. However, be careful not to make it overwhelming. Good logo positioning helps anchor your brand in visitors' memory and reinforces your professionalism.

But the visibility of your participation in the MEDICA trade fair is not limited to the event itself... it starts well in advance. To make an excellent impression and maximise your impact, actively communicate about your presence through well-chosen digital and professional channels.

Start with a targeted email campaign, informing your clients, qualified leads and partners of your participation. A clear, dynamic and personalised message, accompanied by a visual of your stand or your flagship products, will encourage recipients to come and meet you. Include a registration link or a form to book an on-site appointment in this email.

On social media, announce your presence several weeks in advance, then maintain the pace with regular posts. Use attractive visuals, product teasers and short videos to generate interest. Don't forget to include the official trade fair hashtags (#MEDICA2025, #MEDICA) to gain visibility within the professional community. Instagram and Facebook stories as well as LinkedIn posts are ideal for creating an atmosphere around the behind-the-scenes of your preparation.

Also consider updating your email signatures by integrating a banner announcing your participation, such as "Find us at MEDICA 2025 – Stand XX". This allows you to spread the information discreetly but systematically with every professional exchange.

During the trade fair: capturing leads, analysing contacts, managing peak traffic

For effective participation in MEDICA, it is essential to manage peak traffic well. These usually occur between 9:30 am and 12:30 pm, then again between 2 pm and 4:30 pm. It is essential to organise the reception team accordingly. There must be sufficient staff and optimal distribution of roles in order to respond effectively to the flow of visitors. This organisation allows you to methodically manage the many visitors without being overwhelmed by their demands.

You can also offer personalised content to maximise interest. Brochures or QR codes leading to digital content can, for example, enhance the customer experience while making your statements uniform and clear.

Moreover, the use of goodies at a professional trade fair like MEDICA is an excellent lever to attract visitors' attention. In a dynamic and competitive environment, every visual element counts, and a well-thought-out promotional item can become a real magnet for visitors. By having these items on your stand — whether pens, tote bags, notebooks, or other useful accessories — you naturally encourage passers-by to stop, interact and start a conversation with your staff.

Beyond the immediate appeal, goodies fulfil an essential strategic function by making an impression on visitors. By leaving with an item bearing your company's name or logo, they take away a tangible memory of their visit to your stand. This physical link extends the impact of your presence, embedding you in their memory long after the trade fair ends.

Finally, goodies can also be a conduit for transmitting values and brand image. An eco-friendly design or innovative item says a lot about how you wish to be perceived. By choosing items in line with your positioning, you create coherence between your commercial discourse and the experience lived by visitors.

One of the major reasons for participating in MEDICA is making contact, a fact that should not be overlooked. It is advisable to facilitate this as much as possible by creating contact points before the trade fair to prepare meetings and facilitate contact. To this end, you can do the following:

• Use an appointment scheduling tool (like Calendly). Create a personalised link to allow qualified leads to book a slot according to your availability. Include this link in your emails, signatures, social networks or web pages dedicated to your presence at the trade fair. Actively promote this tool in your pre-trade fair communications.
• Provide online contact forms: Collect contact details with a simple page and consider adding a QR Code to your communication material that directs people to this form.
• Take part in proactive communication: Contact certain target visitors or partners in advance via email, phone or LinkedIn to propose a meeting. Inform them of your presence at the trade fair and offer available slots.

Of course, contact is also made during the trade fair, you can use:

• Paper forms: Offer forms to be filled out manually for visitors who do not wish to use a digital format.
• Online forms accessible via QR Code: Clearly display QR Codes on your stand allowing visitors to fill out a quick form from their smartphone.
• Official trade fair app — Scan2Lead: Use this app to scan visitors' badges and instantly retrieve their information. All data is centralised for easy processing after the trade fair (available for iOS and Android).

After MEDICA: follow-up with prospects, reminders and return on investment

Once the trade fair is over, do not let the commercial momentum fade away. Analyse the data collected at your stand, identify the most promising contacts and quickly engage in personalised follow-ups. Your CRM then becomes your best ally to track each interaction, turn leads into concrete opportunities and accurately measure the return on investment of your participation. It is in this post-event phase that the true value of MEDICA is played out.

At AbroadLink, we will be present at the 2025 edition of MEDICA for the third time to support companies in the healthcare sector with their specialised translation needs. You will be able to meet Josh Gambín and Alex Le Baut who will represent our company in hall 12, stand B24, where we will be delighted to discuss your multilingual projects with you.

According to the EU Medical Device Regulation (MDR) language requirements, manufacturers must provide clear and localized Instructions for Use (IFUs) for each relevant market. While necessary for compliance, multilingual IFUs can represent a significant portion of the documentation budget, especially for companies operating across multiple jurisdictions.

Below are five practical strategies to help reduce translation costs while maintaining compliance and documentation quality.

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1. Optimize the IFU Source Content

Translation costs are typically calculated per word. Therefore, reducing word count at the source can result in substantial savings, particularly when IFUs are translated into many languages.

In order to achieve this, you should:

• Use concise, standardized phrasing.
• Avoid redundancy.
• Apply structured writing principles: consider using tools like MadCap Flare or Adobe FrameMaker, which allow content to be organized in reusable modules or blocks.
• If IFUs are already written, carrying out a pre-translation editorial review to simplify language and eliminate unnecessary content can significantly lower costs, especially when translating into 10+ languages.

2. Use Visuals to Replace Repetitive Text

Clear illustrations or diagrams can convey instructions more efficiently than lengthy descriptions, with the added benefit of not needing a translation. This approach becomes more cost-effective the more languages you support.

Visuals are especially effective for step-by-step processes, warnings or assembly instructions. Before adding any visuals, ensure that they all comply with MDR requirements and are validated during usability testing.

3. Author IFUs Directly in English

English typically uses fewer words than many other European languages, such as French or Italian. Writing the original IFU in English can therefore reduce the total word count and create a more efficient basis for translation. Furthermore, English is also the most common pivot language in translation workflows, simplifying project management.

Apart from being a way to reduce the word count, translating from English may have other advantages. If you want to know further, read 3 reasons for and 2 against translating from English.

Keep in mind: English phrasing must remain clear and compliant for all user populations, including non-native speakers.

4. Consider AI Translation with Post-Editing (MTPE)

For some types of content, AI translation followed by professional post-editing can offer a balance between cost and quality. However, its feasibility and gains of productivity depends on:

• The technical complexity of the IFUs.
• The clarity and consistency of the source text.
• The availability of custom-trained translation engines adapted to your product range.

To improve MT output, write in plain, unambiguous sentences and avoid idiomatic or creative language. This makes content more predictable and easier to translate accurately.

5. Leverage Translation Memory and Format Consistency

Most translation agencies now use Translation Memory (TM) systems to detect and reuse previously translated segments. This results in lower costs and faster turnaround.

To maximize reuse:

• Maintain consistency in phrasing across all IFUs.
• Standardize document formatting: A sentence in bold or with different spacing might not be recognized as a repetition by the TM tool.
• Use documentation tools that support modular content reuse and multilingual version control (e.g., FrameMaker, Flare, or XML-based systems).

Well-maintained translation memories and consistent formatting can lead to significant cost reductions over time, especially for devices with multiple configurations or accessories.

Conclusion

Reducing IFU translation costs is not about cutting corners, it’s about creating compliant and reusable content. By combining strategic authoring, smart tools, and close collaboration with translation providers, regulatory and documentation teams can ensure both cost-effectiveness and MDR compliance.

If your organization publishes IFUs in multiple EU languages, applying even a few of these strategies can make a tangible difference to your translation budget.

Do you need help translating your instructions for use? Contact us, we are a translation service provider specialized in medical devices and we will be happy to help you.

One of the main objectives of Regulation (EU) 2017/745 on medical devices (MDR) is to enhance patient safety through a uniform market surveillance system. However, it is precisely in the application of these regulations where a significant problem arises: the conceptual ambiguity and confusion between the terms 'adverse event' and 'serious incident'. This terminological inconsistency is more than just an imprecise use of language, it carries real risks for manufacturers, consultants and the reporting process to the competent authorities.

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The MDR: defined terms, distinct scope

In the preamble of the MDR, recital no. 79 states the following: 'The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.'

This is also reflected in the definitions of Article 2:

'Incident' (Article 2, point 64): any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

'Serious incident' (Article 2, point 65) any incident that directly or indirectly led, might have led or might lead to any of the following:

• the death of a patient, user or other person,
• the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
• a serious public health threat.

'Adverse event' (Article 2, point 57): any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

'Serious adverse event' (Article 2, point 58): any adverse event that led to any of the following:

• death,
• serious deterioration in the health of the subject, that resulted in any of the following:
  • life-threatening illness or injury,
  • permanent impairment of a body structure or a body function,
  • hospitalisation or prolongation of patient hospitalisation,
  • medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
  • chronic disease,
• foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

IMDRF: Global classification framework, without legal value

The document IMDRF/AE WG/N43 FINAL:2020, produced by the International Medical Device Regulators Forum (IMDRF), establishes detailed terminology to define adverse events (AE) and serious adverse events (SAE). It equates incidents/events that are treated differently by the EU.

The IMDRF itself states:

'Depending on jurisdictions, the terms "adverse event" (in its post-market meaning) and "incident" can typically be used interchangeably.'

This lack of definition creates uncertainty. The IMDRF terminology serves as a technical coding system, but it is not legally binding within the MDR framework.

A reportable event in the context of an inaccurate translation could correspond to IMDRF codes A21 or A2101 related to instructions for use or labelling:

European Commission: MDR Term + IMDRF Code = Obligation

Since 2020, the European Commission requires manufacturers to classify serious incidents using the IMDRF codes of the 'adverse events' system in the MIR form (see the European Commission's FAQ sheet). This does not constitute a terminological incorporation, but merely a technical tool to standardise data analysis:

'Notably, the word "adverse event" in the present context includes (serious) incident as defined in the EU (MDR art 2. definition 65).'

In the UK, the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA), which has defined clear procedures for the reporting of incidents by users, operators and distributors. In this link, the MHRA provides detailed information for reporting incidents.

The manufacturer must investigate this notification, give their opinion and, if necessary, initiate corrective actions. In turn, the MHRA carries out a risk assessment.

On the other hand, (serious) adverse events that occur in the clinical investigation of a medical device must be reported through EUDAMED or the Yellow Card Scheme run by the MHRA. The form for reporting through the Yellow Card Scheme is available at this link.

USA: Standardised use of terms, but not transferable

The United States Food and Drug Administration (FDA) uniformly uses the term 'adverse event' for all safety-related events, both in clinical trials and after the authorisation of the device. Manufacturers must report events related to death, serious injuries or device malfunctions in accordance with Part 803 of Title 21 of the CFR. The clear use of terms is consistent, but is not compatible with the MDR.

Conclusion: Terminological precision is a regulatory necessity

The MDR requires the use of the term '(serious) adverse event' in the context of clinical investigations and the term '(serious) incident' in post-market surveillance. The IMDRF coding is only a technical classification tool and should not lead to misunderstandings regarding terminology within the European Union.

Recommendations for manufacturers and regulatory affairs managers:

• Use 'adverse event' only in the context of clinical investigations (e.g., when preparing your technical documentation).
• Use '(serious) incident' for all reportable cases after the making available on the market.
• Take into account that the IMDRF terminology is used solely for coding purposes and not for selecting terms, even in the case of AE and SAE.
• Ensure that the terminology is appropriate in other languages when translating your technical documentation or Field Safety Notices (FSN).

Correctly speaking the language of the regulations is essential in order to meet MDR requirements and gain the trust of authorities and patients.

An experienced language service provider specialising in medical devices will ensure that both technical terminology and regulatory requirements are correctly applied in each target language. Only precise and context-specific terminology will protect against reporting errors and legal risks. Translations must also comply with the MDR, so it is crucial to work with specialised language service providers who combine regulatory expertise with linguistic precision.