Commission proposal being drawn up for postponement for date of application of MDR (2017/745)

[twanmul]

Being drawn up as per this Video Link to delay the Medical Device Regulation deadline by 1 year (he says delay of entry into force, though I think he means date of application) to enable the industry to prioritise activities related to and that have occurred as a result of the coronavirus.

 

[twanmul]

The commission has now officially postponed until 26th May 2021 as per this press release.

IVDR DoA remains unchanged as 26th May 2022.

 

[dgrainger]

Don't forget that "The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure."

 

[twanmul]

Don't forget that "The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure."

Good point, though I figured this is essentially just a rubber stamping process especially given the circumstances.

 

[dgrainger]

Proposal updated:
MDR amendment proposal article 120 (3) oversight set to be fixed by Council

 

[atitheya]

Does this also mean that organization/s can still apply for MDD?

Just talking of possibilities.

 

[twanmul]

Does this also mean that organization/s can still apply for MDD?

Just talking of possibilities.

I have had communication from my NB saying that they have re-opened for submissions under the MDD as a result of this. It may be worth speaking to your NB (might be harder if they are designated under the MDR) if this is something that is of use to you.

 

[Edugar]

Now the delay of the date of application of the EU MDR 2017/745 is published in the official journal of the EU Commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2020:130:FULL&from=EN