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!