AbroadLink attends the fifth TEAM-PRRC 2026 meeting in Prague

AbroadLink attends the fifth TEAM-PRRC 2026 meeting in Prague to gain first-hand insight into the challenges faced by persons responsible for regulatory compliance (PRRCs). On 29 and 30 October, I represented our company at the Hilton Old Town Hotel, over two days of presentations, round-table discussions and conversations with manufacturers, consultants, competent authorities and notified bodies.

As a translation company specialising in medical devices, we need to understand the context in which our clients operate. This edition of TEAM-PRRC brought one issue particularly to the fore: how can the MDR and IVDR be simplified without losing sight of patient safety or device availability?

AbroadLink at the fifth TEAM-PRRC meeting: key sessions

Reform of the European regulatory framework took up a significant part of the meeting’s programme. Among the sessions exploring the proposed changes, particular attention was drawn to those incorporating the perspectives of people overseeing or assessing compliance:

• The opening round-table discussion on simplifying the MDR and IVDR, moderated by Bassil Akra. The programme featured contributions from Françoise Schlemmer, director of Team-NB, and Helena Dzojic from the Swedish Medical Products Agency, alongside representatives from Healthtech Finland, BVMed and SNITEM. It offered insights into the reform from the viewpoints of industry, competent authorities and notified bodies.
• Proposed changes to quality management system audits and recertification, presented by Ilkka Juuso, lead auditor at SGS. A particularly valuable session for understanding how oversight could evolve throughout a device’s lifecycle.
• Proposed reductions in notification and reporting requirements, with contributions from Jenifer Hannon from BSI and Franck Zal, CEO of Hemarina. The programme aimed to compare the perspectives of the manufacturer and the notified body.
• New conformity assessment pathways to support innovation, with Richard Holborow from BSI. The announced topics included innovative devices, orphan devices and regulatory sandboxes.
• The round-table discussion on the changes to Annex VII, featuring representatives from BSI, AFNOR Certification, TÜV SÜD, GMED and DNV. The discussion focused on assessment timelines, capacity, transparency and the challenges facing SMEs.

Team-NB’s participation in Prague underlines the value of bringing different stakeholders together to exchange their views in a shared discussion. The programme also included sessions on clinical data, post-market surveillance, EUDAMED, artificial intelligence and PRRC responsibilities.

Simplification: yet another MDR complication!

Simplifying processes that consume resources without delivering proportionate benefits can only be welcomed. Patients, manufacturers and notified bodies alike can reasonably question why the legislator did not get the balance right from the start.

The irony is that, as parts of the industry are finally becoming familiar with the MDR and IVDR, they will now need to interpret new provisions, revise their procedures and consult newly published or updated MDCG guidance. Indeed, simplification comes with a new layer of complexity.

The European Commission’s proposal to revise the MDR and IVDR, presented on 16 December 2025, remains at the legislative proposal stage. Its provisions must be negotiated and approved before they can become legally binding. This distinction matters when planning any changes.

Based on the discussions at the meeting, some notified bodies may find the transition particularly challenging. They have invested in teams and capacity to meet current requirements. Reducing certain activities could force them to reassess that capacity. This is a possible consequence of the reform, although its extent will depend on the final text.

Additional requirements do not necessarily lead to improved safety

Patient safety requires robust controls. It also requires devices to be available and innovation to reach those who need it. When an administrative burden consumes resources without delivering equivalent benefits, it is worth asking whether it is serving its intended purpose.

One indication of the difficulties involved in the transition was the extension of the deadlines under Regulation (EU) 2023/607. Certain devices covered by the previous regime may continue to be placed on the market until 31 December 2027 or 31 December 2028, depending on their class and provided they meet the specified conditions. The extension was designed to mitigate the risk of supply shortages, rather than provide a general authorisation for all products.

In Prague, I once again heard concerns that had emerged at previous industry events:

• Resources devoted to certifying existing devices that had barely changed by the end of the process.
• Budgets and time that manufacturers would have preferred to invest in development and innovation.
• Companies that regard the United States as their main target market, particularly when developing innovative technologies.
• Devices whose continued commercial availability on the European market is being questioned because of the cost of maintaining them there.

These experiences do not demonstrate that all requirements are unnecessary. They do, however, raise a question: what impact do disproportionate burdens have on access to products and, ultimately, on patients? The cost of delayed innovation or a device being withdrawn from the market also matters, even if it is less visible.

But let’s focus on the positives: recognising the need to change course is a sign of wisdom. I came away with the impression that many of the proposed changes had been favourably received by industry and notified bodies alike. Bassil Akra called for Europe to regain its appeal as a market, recalling processes that could be completed in three to six months under the Directives. Restoring agility and predictability is an aspiration worth supporting.

What could change in terms of translation requirements?

The language dimension is also part of the debate. The Commission’s proposal suggests that Member States consider accepting another official EU language when deciding which languages manufacturers must use for their information. In doing so, they should consider the technical knowledge, experience and training of the intended user. This does not mean that English would automatically be accepted throughout the EU.

The draft report by European Parliament rapporteur Oliver Schenk proposes going further. This would mean information in English for devices intended exclusively for professional users. This remains a proposal as part of an ongoing legislative process and does not constitute an exemption from the language requirements currently in force.

In my view, the Commission's proposed wording may have a limited effect in contexts where English is already permitted for specific professional purposes. The language requirement tables published by the Commission show differences between countries. In the August 2025 revision, Spain, France and Italy are listed as requiring their national language for labels and instructions for use, including for professional users.

For this reason, any savings will depend on the wording ultimately adopted and how it is applied. When it comes to IFU translation, user understanding remains crucial. Working in a professional setting does not, in itself, guarantee that everyone can understand complex technical information in English.

A community that helps make sense of the changes

I would like to finish by congratulating Elem Ayne, president and driving force behind TEAM-PRRC, together with the other board members (Anne Jury, Bassil Akra and Sandra Ferretti), on organising the event and building this PRRC community. Its value lies not only in the presentations but also in the conversations that continue during the breaks.

Bringing competent authorities, notified bodies, manufacturers and consultants together in an informal setting helps everyone gain a better understanding of the challenges faced by each group. AbroadLink’s participation in the fifth TEAM-PRRC 2026 meeting in Prague helps us apply this knowledge to our medical device translation services.

If you are considering the potential impact of these changes on your multilingual documentation, we can help you evaluate your translation requirements. In the meantime, we will continue to monitor developments in the reform and follow the discussions within this community. We look forward to seeing you in Lisbon next year!