New EU Regulations

Context

INTRODUCTION

Since May 26, 2021 a new regulation regarding Medical Devices (MD) replaces two directives dating from the 90s. The (EU) 2017/745 regulation replaces directives.

and from May 26, 2022 the Regulation (EU) 2017/746 regarding in vitro diagnostic medical devices will replace the directive :

Gradually CE marking certificates established under these directives will become invalid and medical device manufacturers must update their technical documentation and possibly obtain a new CE marking certificate from the newly designated Notified Bodies.

Notified Bodies (NB)

Safety rules have tightened considerably, more and more of these products must now be assessed by Notified Bodies. But these institutions are also put to the test by European authorities, the NBs and their experts must demonstrate the absence of conflict of interest and must respect rigorous processes. The consequence is a sharp decrease in the evaluation capacities of NBs, their number has strongly reduced from around 80 in 2014 to 24 today and the amount of work required for these evaluations has increased significantly.

It is highly likely that only the best-prepared manufacturers will pass this major regulatory change, without a hitch.

Are you ready?

Biorius can help you take this step.

BIORIUS SERVICES CONCERNING THE NEW REGULATION

Services for MDs Already on the Market:

If you have MDs that have already been marketed in the European Union you must comply with the new regulations.

Biorius can assist you with certain steps:

Services for New MDs:

You have a project for a new product that you want to market in the EU as a Medical Device, but you don’t know how.

Biorius can assist you with certain steps:

Post-Market Activities:

But all this is not enough, the manufacturer must also put in place:

  • Post-Market Surveillance (PMS)
  • A Vigilance system to collect notifications of incidents or risk of incidents

Contact Us

Don’t hesitate to contact your dedicated account manager or your sales representative to have access to this service today.

Otherwise, just click on the bottom.

See below or download our document about the European Union Medical Device Regulation

Contact

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+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

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