Translation Under the MDR and IVDR: A look back at the webinar organised with Team-PRRC

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.

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.