Final Medical Device Regulations replacing MDD 93/42/EEC, etc.

L_O_B

Involved In Discussions
Re: Final Medical Device Regulations?

Put the documents side to side and take a look at the pages. There is not a lot more text. They just decided to only use 2/3 of the space of each page. Also the number of articles stays the same: 123. The numbering changed though. Keep calm, there are some important changes but most of the differences are simply another wording compared to the version of August 2016.
 

Marcelo

Inactive Registered Visitor
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

The differing number of pages is due to the formatting required to be published in the official journal, but the text is very likely the one from the last draft.
 

Chrisx

Quite Involved in Discussions
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

I'm debating about creating bookmarks for the various articles. I did this for the draft and it makes it much easier to navigate. It's a significant job to bookmark the whole thing. Is this document now completely final or is it open to some final edits?
 

dgrainger

Trusted Information Resource
Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

It still needs to go to the EP - hopefully without change!

PS there is a lot of white space in this version.
 
L

lewisking34

Re: Final Medical Device Regulations replacing MDD 93/42/EEC, etc?

Hi,

Assuming the MDR is officially published after passing through European Parliament, it becomes law across the EU with a 3 year transition/phase-in period (in layman's terms).

Although in the midst of leaving the EU, the MDR will come into effect in the UK after being published. We, in the UK, will all have to work towards the new MDR in the transition phase... however after the UK leaves the EU, presumably in mid-2019, will we still have to work towards the MDR?

I understand the law is the law, and initially I thought the answer was 'obviously yes', however on reflection, I'm not so sure... this one has clouded my thinking a little so I'd like to hear anyone else's thoughts.

All the Best,
Lewis
 
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