Authorized Representative Services
MDR Countdown
27
29
30
00
30
Days
21
22
23
00
23
Hours
57
58
59
00
59
Minutes
57
58
59
00
59
Seconds

Total excitement on social media because of MDR Corrigendum!

In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant extension, was substantiated last week with the proposal of a second corrigendum. It still may need to go through the Parliament but it passed another hurdle. The regulatory community got all excited and information on social media exploded (we are on LinkedIn - please feel free to connect!).

The Parliament Committee on the Environment, Public Health and Food Safety voted in favor of the corrigendum. Here for the record is the vote! Go to 11:33:30 to see the vote and also the serious comment made.

This provides a great relief for risk class I products that will need the involvement of a Notified Body under the MDR. The products may be placed on the market until May 2024. Please note, certain conditions apply.



Final voting has to go via the Parliament. Let us hope for the best!



28-11-2019

Possibly 4 more years for class I products which must be certified under the MDR (e.g. reusable surgical instruments (Ir), software or substances). The second corrigendum has been published and it is up for final approval. Everything is possible.



Let’s hope for the best!

Second Corrigendum to the MDR

Add Comment

* Required information
1000
Captcha Image
Powered by Commentics

Comments

No comments yet. Be the first!
MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

Share

We use cookies and other tracking technologies to improve your browsing experience on our website, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies.