Participation of AbroadLink in the 4th Annual TEAM PRRC Congress in Rome

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

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.

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