Brexit - European Commission - The impact of the Brexit per March 29, 2019

RobertvanBoxtel

Involved In Discussions
#1
Dear all, last week the European Commission published a document outlining the impact of the Brexit per March 29, 2019.

http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=612136

Depending on your economic operator role and where you are located, you might have to take actions as no CE certificates from UK Notified Bodies will be accepted anymore.
Also, you might suddenly need a new EU Authorized Representative, if they are now located in the UK.

Unless Mutual Recognisation agreements are set-up, this will be reality.
 
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Paul Simpson

Trusted Information Resource
#2
The critical phrase in the linked document is this one:
Subject to any transitional arrangement that may be contained in a possible withdrawal
agreement ....
The UK conformity assessment industry is working hard to stay part of the EU notification process and it will be interesting to see where we end up come March 2019.
 

Marcelo

Inactive Registered Visitor
#3
The UK conformity assessment industry is working hard to stay part of the EU notification process and it will be interesting to see where we end up come March 2019.
However, medical device regulations do not use the conformity assessment industry, right?

I mean, you don't include Notified Bodies as conformity assessment industry? They are a type of conformity assessment industry, however, as they are notified by Regulatory Authorities, they are a little different from common accreditation schemes.
 

Paul Simpson

Trusted Information Resource
#4
However, medical device regulations do not use the conformity assessment industry, right?

I mean, you don't include Notified Bodies as conformity assessment industry? They are a type of conformity assessment industry, however, as they are notified by Regulatory Authorities, they are a little different from common accreditation schemes.
Hi, Marcelo. Yes, MDD Notified Bodies are part of the Conformity Assessment Industry. In much the same way as NoBos for PED, PPE, Railway Interoperability etc. are part of that industry. If you have to look at the NANDO lists you'll see it is the same companies that operate across most of the directives with some specialists in each of the fields. I've used MDD as an example but the same principle applies for different Directives.
 
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