Status of Medical Device Regulations in UK Post-Brexit

Mark Meer

Trusted Information Resource
#1
Can anyone kindly link to where there is some authoritative documentation on the current requirements for sale of medical devices in the UK post-brexit?

I've been searching on the UK.gov website for pages updated since October, but can't seem to find anything clearly laying out what's changed (if anything).

In fact, their Medical devices: conformity assessment and the CE mark page hasn't been updated since 2016!

Can I continue to market my CE-marked devices in the UK? ...or are there now some additional requirements/regulations?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Generally speaking, EU law continues to apply in the UK at least until end 2020, and that might be further extended by July this year. That includes CE marking.
I'd have chased official statements for you had you paid me to do it, but you won't... :)
 

Mark Meer

Trusted Information Resource
#3
What about talk of having to have a dedicated UK Authorised Representative? Was that ever rolled out, or is it still acceptable for now just to have an AuthRep based in the EU?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
What about talk of having to have a dedicated UK Authorised Representative? Was that ever rolled out, or is it still acceptable for now just to have an AuthRep based in the EU?
While EU law applies in the UK, it's business as before. Whatever was acceptable up til Brexit continues at least until end 2020. If there's no extension (and there will probably be one), a UK rep will be required from Jan 1st 2021.
 

Watchcat

Trusted Information Resource
#5
A bit off topic, but I'm already getting the impression that the Authorized Reps are going to be something of pain for the near future. It seems that due to their increased liablity (of which I have only heard about, but have no first-hand knowledge), they are trying to step up their game and start advising clients regarding MDR compliance more than it was my impression they had typically done in the past. That would be fine, except...since they didn't do so much of this in the past, they don't seem to be very good at it. So I'm hearing of Authorized Reps giving advice that conflicted with that of their client's NB.

I think this is one of those situations where it matters less who is "right" and who is "wrong," but that one party or the other needs the authority to decide, and the other party absolved of responsibility for the first party's decision. Otherwise, this is all enough of a snarly mess already, don't need any more snarls. I think this is especially true under current circumstances, where what is "right" and "wrong" is still so often a matter of interpretation.

Just wondering if anyone else had heard of NB and Authorized Rep advice conflicting, as well as thoughts on how clients might resolve this type of conflict if it happens to them.
 

Mark Meer

Trusted Information Resource
#7
...Just wondering if anyone else had heard of NB and Authorized Rep advice conflicting, as well as thoughts on how clients might resolve this type of conflict if it happens to them.
I didn't think providing "advice" was within the mandate of either NB or AuthRep. As far as I know - at least according to my NB auditors - NBs have to be very careful about crossing certain lines when it comes to "advising" their clients...
 

Watchcat

Trusted Information Resource
#8
I didn't think providing "advice" was within the mandate of either NB or AuthRep.
I was thinking more along the lines of advising in terms of notifying than in terms of providing guidance although I agree that line can be thinly drawn. In general, I distinguish them as communications about "what" versus communications about "how to."

I have mostly seen these conflicts centered around Article 120/Corrigendum 2, where the NB advises a client regarding its expectations for conformance to some or all of the MDR by May 26, and the EU Authorized Rep says this is wrong. I don't know that I would go so far as to say that that an NB's "advice" on what exactly it is that the client should be conforming to is within its mandate, but since it is the NB's job is to assess conformity with whatever that is, I think it is pragmatically/rationally part of its job, making way more sense to me than for the NB to sit quietly mute until the tech file review to surprise with client with this information.
 

Mark Meer

Trusted Information Resource
#9
...I have mostly seen these conflicts centered around Article 120/Corrigendum 2, where the NB advises a client regarding its expectations for conformance to some or all of the MDR by May 26, and the EU Authorized Rep says this is wrong. ... I think it is pragmatically/rationally part of its job...
Agreed. With respect to any conflicting advice with respect to Article 120, I would be likely to favour NB information, as they have way more "skin-in-the-game" with respect to this Article.
 
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