This week I have been attending the numerous sessions presented during the MedTech Summit

The topics for discussion serve as a stark reminder that our medical device industry remains inadequately prepared for application of the MDR and IVDR regulations. For example:

  • Path to Compliance: Industry EU MDR
  • EUDAMED update: Status and Future Timelines of Implementation of the EUDAMED Database
  • Strategies to Manage your Distributor Regulatory Risk
  • Meeting the New PMS Reporting Requirements of MDR & IVDR with Future-Proof Systems

Granted, I understand that 2020 has been a challenging, arduous and hellacious year but it appears, based upon some of the audience questions, that there are organisations who have not yet begun considering how they will implement actions to ensure compliance.

If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??

I would really like someone to explain to me, just what is the problem with preparedness??

  • Is it a lack of understanding or awareness of the requirements?
    • Who lacks the understanding?
    • How do we get them to understand?
  • Is it a lack of resources?
    • How to approve the funding allocations?
  • Do they think application will be delayed again, therefore have even more time?
    • Wishing for another crisis? I hope not.

This lack of readiness does not bode well for the future of the European medical device market from 2021. Well at least in the immediate future.

  • Will those companies who are “ready” dominate the EU market?
  • Will the smaller SMEs disappear altogether?
  • What will happen to product availability?

I know that I have asked a lot of questions. If anyone has the answers, I would love to hear from you.

Back to the conference…..

K Young