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

ugecha

Starting to get Involved
#1
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.)
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
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

Involved In Discussions
#3
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

Involved In Discussions
#4
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

Problem Solver
Staff member
Moderator
#5
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...
 
#6
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

Hunkered Down for the Duration
Staff member
Admin
#7
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... :popcorn:
 

SteveK

Trusted Information Resource
#8
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?
 
#9
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.
 
Last edited:
#10
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.
 
Thread starter Similar threads Forum Replies Date
B Retention Samples when Customer Leaves Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Jen Kirley My son leaves for the Air Force today Coffee Break and Water Cooler Discussions 30
Jim Wynne What do you do with Autumn Leaves? Coffee Break and Water Cooler Discussions 30
K Roh Moo-hyun leaves a legacy shaped by contradiction World News 0
S When wife leaves the child to husband.... Funny Stuff - Jokes and Humour 5
J Re-approving documents when the responsible person leaves or changes responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
B Document Approval when the responsible person leaves the company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N A Man Leaves Home - Teaser - Easy Brain Teasers and Puzzles 5
Marc Plane Delay Leaves Hundreds Whiney Travel - Hotels, Motels, Planes and Trains 0
Marc Cities face life without 16 Ford plants - Ford leaves cities in limbo World News 0
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K What is supposed to happen when a CA cannot be closed out or the root cause... General Auditing Discussions 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R IEC 62133 to satisfy 60601-1 3rd edition - What happen to 60086-4 Other Medical Device Related Standards 18
J What will happen if you can't answer questions of recruiters? Career and Occupation Discussions 4
M FMEA for Drilling Process - What kind of failure can happen during drilling process? FMEA and Control Plans 8
AnaMariaVR2 Jason Fried: Why work doesn?t happen at work Career and Occupation Discussions 3
bio_subbu Never happen in life again??!!!! Coffee Break and Water Cooler Discussions 4
A Repeat Major NC - What can happen during External Audit by Registrar General Auditing Discussions 23
J Changes to AIAG's FMEA manual to happen in the 3rd quarter of 2007 FMEA and Control Plans 10
T ISO 14001 Registered and out of Compliance - What should happen? ISO 14001:2015 Specific Discussions 13
K What will happen if our QMS, which is QS-9000, certificate expires? IATF 16949 - Automotive Quality Systems Standard 4
B Will ISO 9001 be modified in 2008? What will happen to TS 16949? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
N European Authorised Representative (also called Authorized Representative) - Cost competitive recommendation EU Medical Device Regulations 1
Marc Regulation (EU) 2017/745 of the European Parliament EU Medical Device Regulations 12
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 3
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
W Sale medical device to European Hospitals Hospitals, Clinics & other Health Care Providers 1
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
E European Weld Callouts - Confused with the "/C" and the "a2" portions Various Other Specifications, Standards, and related Requirements 7
H European Pharmacopoeia First Identification Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8

Similar threads

Top Bottom