There is unlikely to be any change except for anything involving the UK and it's MHRA. CE Marking will still be a European requirement, and quite possibly a UK requirement for the foreseeable future.

Gabriel Adusei, MSc, PhD CE Mark and the regulatory framework that governs it will remain unchanged. Perhaps, the negotiations to follow will seek to maintain most of the best parts that work for both parties, namely UK and EU. Perhaps the relationship of Switzerland, Norway, etc.. and EU will be model to consider for UK where CE Mark is mutually recognized.

MHRA in my opinion is not going to throw away all the hard work put into the development of the new regulations.

Negotiations, Negotiations, Negotiations!

Karen Boyd, ASQ CQA Great questions, Julie. I thought about the potential impact while the voting was in progress. I would hope that CE certs already issued would be valid to their expiration dates. Although the UK has chosen to exit the EU, would they "honor" or accept CE marked product as legally equivalent to whatever method or governing directive / standard they elect to prescribe or subscribe to in future? Last I knew, there are other countries, independent of EU, that consider CE marked product for import into their marketplace. I would like to think that the UK, like anyone, wouldn't want to "cut off their nose to spite their face".
Brexit's impact on finalizing the new MDR/IVDR - who knows? Curious to hear the answers!

Julie Omohundro Karen, I would also expect the UK to continue to accept CE marked product.

Julie Omohundro It's been awhile since I reviewed CA/NB 101 and I haven't had a chance to dig into these fundamentals today, but I've always been under the impression that:

- An organization can only be designated as a notified body by the competent authority in the country where they are based.

- A competent authority can only designate an organization as a notified both if it is based in the CA's Member State.

- Only the regulatory agencies of the Member States can be CAs and designate notified bodies.

If all of the above are correct (?), then, once/if the UK exits the EU, MHRA would no longer be an EU CA and would no longer be able to designate notified bodies.

Ee Bin Liew getting out of the EU, new regulations, new leaders and so on, first and foremost, should have as little as - if not at all - impact, on the protection of public health. Part of protecting public health is ensuring its safety, efficacy, and removing harm along the way via post market surveillance, but the other part is to keep the supply going, and continue for devices (and everything else, essentially) to gain market access to benefit public health. Even if there're any changes, there would be discussion, alignment, governmental approval transition phase etc. so either way, all of us should have sufficient time. If we complain less and give constructive suggestions on how any changes can be realised practically on the ground, that'd help things get done smoother. That's what we can do.

Nothing prophetic, I'm afraid... hope to just view things in a simpler perspective.

Cheers,
Ee Bin

Dr. Patrick Druggan There will be no impact on the MDR and the IVDR as these are EU regulations. Britain will need to decide if it wishes to implement its own recast to harmonise it with the EU or not, but that is irrelevant in this case. The CE certifications will need to be from notified bodies designated by the EU, but the notified bodies are multinational so this is not a significant issue. UK manufacturers will need to obtain an authorised representative in the EU if they intend to sell in the market, and will have to comply with the MDR and IVDR. So more a ripple than a tidal wave for the EU, probably more of an issue for the UK

Nebrido Santiago From product perspective - for higher class devices it may not have immediate impact since no intervention from CA i.e MHRA except event reporting, but for class I devices it may or not have immediate effect, who knows MHRA may issue a new rule in the next 12 months adding or limiting the registration of the device, note that they can be by their vested power may issue a mere guidance/instruction with legal effect

For notified body - CA also has power to regulate e.g. inspect, designate so they may impose add criteria - impact may reduce the number of allowed NB to CE

I can speculate so much but I think it boils down to corporate priority of MHRA / UK Dept of Health

Julie Omohundro Patrick, I was wondering if the UK had had strong opinions/influence on some of the more hotly contested points of the new regulations, such that its departure might open up an opportunity for Member States with an opposite opinion to lobby for some of these points to be reconsidered.

Christopher Paris I'm a little stunned at those insisting it's business as usual. The CE Mark is enshrined in EU regulations, issued by the European Parliament. That body -- as well as the EU itself -- is now at risk of collapse, meaning there may well be no regulations at all, and no Parliament to issue them. We are facing a return to pre-EU international agreements, which will take time to set up, whereas the EU collapse could happen at a faster pace, leaving a gap of time without any regulations in place.

I think the truth is that we are in uncharted waters, and anyone having a strong opinion that this "will have no impact" is not speaking with any knowledge or authority.

Dr. Patrick Druggan The process is too far gone for anyone to really stomach changing anything. If you look at ISO 13485:2016 it was too far gone to change to the Annex SL format so was left as it was. The MDR and IVDR are both delayed, and you have a fair point, but I am not aware of any UK specific issues for or against. It is a possiblity, but the political imperative will be getting the recast regulations out as the PIP scandal happened in 2102, and they will be trying to keep things calm rather than carry out blood-letting. A lot of angry people round the table can lead to long days with nothing to show.

Dr. Patrick Druggan There is no impact until there is no membership. That is the law. It isn't an opinion. The UK would have to follow the regulations until it put there own law in place. Notified bodies outside of the EU are authorised to CE mark by the EU. The CE mark also applies to the EEA, so this situation isn't as dramatic as it seems. If the EU collapses, then CE marking won't be what anyone is worrying about, and it takes two years under article 50 to leave.

Dr. Patrick Druggan There are mutual recognition agreements (MRA) with the EU and Australia, Canada, New Zealand and Switzerland for notified bodies capable of issuing CE marking for medical devices. This is not uncharted waters.

Zak Akhoonjee I guess we continue to CE mark and the UK can base their regulation of the EU MDR, or alternatively adopt a new approach. After working on the new MDR I don't see why we would adopt a new approach, it would be simpler to recognise the CE mark as equivalent.

Like Dr. Patrick said, we would have to get authorised representatives in member states to continue selling. And with regards to notified bodies, I'm not sure if we would we have to appoint a new NB within EU in order to carry out conformity assessments?

Potentially the biggest loser here would be MHRA - which would go from one of the key players in framing EU regulation to external observer at best. Have a look at this analysis I wrote as a Pulse article and blog. https://www.linkedin.com/pulse/brexit-ce-mark-implications-european-regulation-arthur-brandwood

https://www.linkedin.com/pulse/brexit-ce-mark-implications-european-regulation-arthur-brandwood

This is a good article by Arthur Brandwood that might be of interest to all

Erik Vollebregt My expectation is the the UK will aim for a similar mutual recognition agreement as Switzerland has for CE marked products. I just wrote an article on my blog about this: https://medicaldeviceslegal.com/2016/06/26/medical-devices-and-the-brexit/

Erik Vollebregt Yes, just wrote a post on my blog about it: https://medicaldeviceslegal.com/2016/06/26/medical-devices-and-the-brexit/

The procedure is that the UK will now enter into negotiations with the EU about divestiture from the EU and has two years for that. In that process instruments of the internal market may be replaced by treaties, much like the mutual recognition agreement that Switzerland has with the EU. That agreement allows Switzerland to have notified bodies and provides for mutual recognition of the CE mark in Switzerland. The EU will certainly not suspend the MDR and IVDR project because of the Brexit because the texts were established following the normal legislative procedure. The texts will enter into force in the EU as planned in the EU's 27 member states. What medical devices law will apply in the UK will depend on where the UK goes. It cannot afford to close itself off of the EU market so it will aim for mutual recognition. The question is when that enters into force, but it will have to be somewhere between now and two years from now.

Ivan Liljegren I hardly think that cutting off access to medical devices for the NHS would be a very popular move with the British people. Even if the EU leaders want to complicate things for the UK, there is nothing stopping the UK/England from unilaterally accepting the CE-mark.

Julie Omohundro It is interesting to hear all the different perspectives. My perspective is always how to advise my clients regarding the best regulatory path for their device. I think I'm getting clearer on that, at least.

Dr. Duggan, I don't think there is no impact until there is no membership, law or no law. There may be no legal impact, but on Friday there was already an impact on the stock market, even though the UK's membership is still very much intact.

I expect there will also be an impact on decisions made by medical device companies regarding CE marking of their products, and that these decisions, like decisions about investing in stocks, will continue to be made every day, not in two years.

Lisa Shaffer Like other countries that are outside of the EU, the UK can simply say "we accept the CE mark". Although they may want to consider developing their own streamlined and simpler regulations when new MDR comes into play.

Dr. Patrick Druggan @Julie O. I wasn't giving my opinion on the stock-markets as these were not within the scope of your question on CE marking. The EU regulations are the law until the UK leaves the EU and that will be two years after they invoke Article 50. Today BSI issued a statement that it will remain an EU notified body. Anyone in the UK wishing to sell in the EU will have to comply with the MDR. I doubt the UK will go to the trouble of inventing a new regulatory environment for MD and IVD - it makes not sense. The most sensible approach would be a mutual recognition agreement as I said earlier. The NHS is in the middle of GS1 - like the US UDI - and the fields are all based on CE marked products. There is little chance that they will change horses mid-stream on this.

Basically nothing changes, if you want to sell in the EU then products will have to meet the essential requirements of the directives. Longer term the only downside forv the UK is that it now no longer gets a hand in shaping these directives.

Robert Lee MS, RAC, CQA Many countries require CE marking as a even though they are not part of the EU. It would not be unreasonable to believe that this requirement will remain unchanged for many years. BSI and other MHRA-designated notified bodies will have to adapt to this new situation by making the necessary changes if they want to stay in business.

Zak Akhoonjee https://www.linkedin.com/pulse/impact-brexit-medical-device-regulations-zak-akhoonjee?trk=prof-post

Robert Barber Back in the 1990's I was involved in the UK industry discussions on the text of the then new IVD Directive. At that time the UK industry was actually crying out for a harmonised regulation across Europe to remove the costs of having to deal with many different national regulations. Since then, if anything, the push for further global harmonisation of the regulatory environment (at least from industry, if not political interests) has only increased. I don't see any reason that this needs to change significantly post Brexit. The only specific thing I have identified so far is that Authorised European Reps will no longer be able to be located within the UK. Unless, of course Scotland votes for independence and rejoins the EU, but then it wouldn't be part of the U.K. Any more.

Nebrido Santiago What is your basis of saying "That body -- as well as the EU itself -- is now at risk of collapse" is that an opinion or a conclusion?

Julie Omohundro Nebrido, "A conclusion is where you stopped thinking." It is an opinion which has a grain of truth, in that the EU is now one country closer to collapse, but that's 1 out of 28, compared to 0 out of 28 a little over a week ago, after years of no exits, so probably not "on the brink." Still, just one more exit could easily start dominoes. That is an opinion, but one widely shared, as far as I can tell. In any case, neither opinions nor conclusions are likely to alter the course of events, and time will tell.

Nebrido Santiago Thanks Julie I know the distinction, sorry but my question is addressed to Christopher above.

So, if the CE marking will probably not be much affected within the next few years, do you think it will be true as well concerning the reimbursement of IVDR and the evaluation process by the NICE?

CE marking will probably continue to be used. Harmonization within the regulatory environment is what we are all striving for within industry. To recreate something different now would be a waste of resources and duplicate much of what is already done.

Karen Boyd, ASQ CQA Here's an article just published via Emergo - http://www.emergogroup.com/blog/2016/06/what-will-brexit-mean-medical-device-companies?utm_source=RADAR&utm_medium=newsletter&utm_term=2pm&utm_content=Worldwide&utm_campaign=5July2016

At this stage - no difference for the rest of Europe - the more interesting questions are the effects on the British based Notified Bodies, UK manufacturers and the MHRA - which could find itself no longer at the centre of the EU regulatory arrangements for Medicines and devices. See https://www.linkedin.com/pulse/brexit-ce-mark-implications-european-regulation-arthur-brandwood

Armin Beck I see one significant issue regarding selling devices in the EU

European Authorized Represent (EUR) and or legal company entity :
If the manufacturer has a EUR or subsidiary company legally located in Great Britain than the manufacturer cannot longer distribute legally devices in the EU. That might have a significant impact on all foreign medical device manufacturer. In addition to changing the EUR and or moving your legal entity to a member state of the EU labeling changes need to be completed.

Best

Armin

Stephane Morvan Well, there are many non-EU manufacturers which are CE marked and which are selling in Europe.

And as Armin pointed out, the Manufacturer needs to appoint a representative in the European Union, which can be readily made by the likes of Emergo etc..., so nothing too complicated here.

The interesting question though, is whether the UK will choose to recognise the CE mark, for EU manufacturer to keep selling products in the UK, or if they will be tempted to come up with their an FDA-like system that will require additional regulatory compliance.

Stephane Morvan the issue for MHRA is that they simply donb't have the resources to implement anything substantial in terms of premarket regulation. See my blog - one option is to become like Australia! https://www.linkedin.com/pulse/brexit-ce-mark-implications-european-regulation-arthur-brandwood

Armin Beck the location of the subsidiary in Europe doesn't necessarily affect things. What matters is if that subsidiary is acting as the EC Authorised Representative (Which I think is what you were referring to). The solution is then to appoint another authorised rep in a member state. The Legal Manufacturer can be located anywhere in the world.

Armin Beck Arthur that is what I referring to the subsidiary that act as the ECAR