What if UK leaves EU? What will happen to European Authorized representative in UK?

[ugecha]

Firstly, welcome back, Elsmar! I am so happy that you've come back.

Now, I'd like to have some advice from experienced people in the world.
Our company's European Authorized representative is a company located in UK. What if UK decides to leave EU, what we should do and how soon we should do? Thank you for your advice in advance. (Of course this is something what we must think about if it happens.)

 

[pkost]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

Nobody knows is the answer to this.

If the vote tomorrow is to leave then nothing will change overnight. Worry about it when there is information available...not before!

 

[RobertvanBoxtel]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

Let's hope it does not happen.
But if it does, there are a number of routes that allow the EU to accept / recognize UK based manufacturers / AR's. For example through MRA's.
Or: these MRA's will not be established and your previous UK (and EU) based AR is not EU based anymore --> change AR.
Same for manufacturers with british NB's: withour an MRA your certificates are not issued by a EU based NB anymore...

 

[Trebor123]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

True - lets hope it does happen - the uk has a far better record than the rest of Europe - my experiences when I have been out and about on mainland Europe no-ones follows Brussels lead.. Only the UK.. we will see...

 

[Ronen E]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

Let's hope it does not happen.
But if it does, there are a number of routes that allow the EU to accept / recognize UK based manufacturers / AR's. For example through MRA's.
Or: these MRA's will not be established and your previous UK (and EU) based AR is not EU based anymore --> change AR.
Same for manufacturers with british NB's: withour an MRA your certificates are not issued by a EU based NB anymore...

There is a precedent for a notified body which is not EU based: the Australian TGA has a NB status. I'm quite certain that a NB like BSI will be able to keep its NB status, one way or another. It's not like there's currently an excess of reliable NBs...

 

[Claes Gefvenberg]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

Ok, exactly what will actually happen in this case is still unclear, but now we know one thing: Brexit is a fact.

 

[Marc]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

My understanding is that the Brexit vote is not legally binding. Cameron is going to resign, leaving this up to the next parliament to decide. Speaking from in front of 10 Downing Street, UK PM David Cameron just stated that he will step down as Prime Minister, explaining that "I think the country requires fresh leadership."

First to congratulate Britain was Holland's Geert Wilders, who is calling for a Dutch referendum as soon as possible... And, French far-right leader Marine Le Pen says there should be a similar referendum about EU membership in France.

This is probably going to be a mess...

 

[SteveK]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

It is reckoned that it will be at least two years before negotiations to leave the EU are complete, possibly even dragging on until 2020 (when the next UK general election is due). Interesting times for us in the UK, and as Claes indicates nobody seems to have a clue as to the consequences. For one example, what will happen with UK based Notified Bodies? Will they just change to a Mutual Recognition Agreement status as per Australia (TGA) and Switzerland?

 

[Claes Gefvenberg]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

My understanding is that the Brexit vote is not legally binding.

It is not, but I can see no way out of it without creating civil unrest. The only way would have been not to open up for the referendum, but that train left the station long ago. Without sparking off any political discussion, I think it is safe to say that things will be interesting for some considerable time. I also expect that we can kiss any glimmer of hope for any economic boom goodbye for the foreseeable future. Stock markets are plunging worldwide, and the £ is taking a right old hammering, dropping to a 30 year low, and still falling. Yes this is clearly developing into a king size mess.

As for Notified Bodies, I don't think (hope?) there will be any change.

 

[jcic43]

Re: What if UK leaves EU? What will happen to European Authorized representative in U

I have talked to several organisations that act as Authorised Reps and are based in the UK, they were already looking at setting up an office in another EU country just in case.

But as already been said we to watch this space and see what happens and not take any knee jerk reactions. The UK will still need medical devices and they will need approval against some form of regulation.