Just returned from an exciting, yet short (2 day) attendance at this year’s MedTech Summit held in Dublin on the Emerald Isle.

So fantastic to meet old friends in person coupled with the networking opportunities to build and create new acquaintances.

European Medical Device Regulations (Live Stream): Unfortunately,  I was only able to attend the conference for 2 out of the scheduled 5 days. However, those 2 days were jammed packed with content that was insightful, thought provoking, definitely educational and timely. Yes, we are still talking about how and when to manage compliance to the European medical device regulation…..

My top 10 key take-aways:

  1. There will not be an extension of the transition period for MDR compliance.
  2. The notified bodies are doing everything within their scope to increase competency and capacity.
  3. Industry needs to get their act together – incomplete submissions, GSPRs not created, lack of communication – not a pretty picture
  4. Keep track and do not miss the EUDAMED deadlines – if your data has not been transmitted in time, it may well mean products may be removed from EU market.
  5. Digitalisation and standardisation are the key to happiness for NB reviewers and will unlock the doors of successful certification for medical device manufacturers.
  6. Get your economic operators (importers, distributors, authorised representatives) into your regulatory and compliance loop.
  7. We still don’t want to talk about Brexit.
  8. MHRA will probably follow the Europe Commissions lead when updating from MDR 2002
  9. Lessons learnt are not being effectively communicated to all the key stakeholders.
  10. European patients may miss out on new innovations in the future.

Thank you to the speakers and organisers for a great conference and I look forward to further engagements 2023.

For those in attendance, I sincerely thank you for listening to my presentation on GSPR compliance. I do hope I provided you with useful information and tips for successful creation and life-cycle maintenance of this critical document.

As always, please drop me a message with your questions and/or comments.

KimYoung@instem.com

K Young