Chapter 2 in the Tale of Brexit, Medical Devices and MDR / IVDR: Suggestions for coping with the regulatory uncertainty

The UK is facing a perfect regulatory storm with the timing for Brexit and the staggered application of the various provisions of MDR and IVDR, with most of the provisions of the latter not being brought onto the UK statute book by the current draft of the EU (Withdrawal) Bill. Without clear guidance from the UK government on this point, it is difficult for medical device companies to know what to do to ensure that they might be able to continue to sell their devices on the market in the UK and the EU27 after Brexit. This post provides some ideas for how to cope with the uncertainty, ensuring you might prepare for the most favourable position in readiness for Brexit (scroll to section 4. at the bottom if you want the advice without the theory).

In my last blog post on Brexit and MRD / IVDR I explained and illustrated the timings which are relevant to the two sets of legislation. If you would like to review this post, please click here.  I promised in that post that there would be another instalment and here that promise is fulfilled.  I discuss below some of the more major questions for medical device companies arising from the timing for the applicability of MDR/ IVDR and that for Brexit and propose some solutions for companies wanting to press ahead with a setting the pathway for their regulatory strategy:

1. Will the UK follow MDR / IVDR ("Regulations") or will it design a new system for regulation?

Lord O'Shaughnessy (Parliamentary Under-Secretary (Department of Health)) and John Wilkinson, head of Medical Devices division at the MHRA, have both publically said that the UK will follow MDR and IVDR.

2. How will the Regulations be brought onto the UK statute book given that the EU Withdrawal Bill as currently drafted does not provide for most of the provisions of this legislation to become part of UK law as we exit the EU at the end of March 2019?

Lord O'Shaughnessy's speech at the ABHI regulatory conference, seemed to indicate that MDR and IVDR will automatically become part of UK law due to the fact that under Article 110(5) IVDR and Article 120(5) MDR companies will be permitted to place medical devices on the market in advance of the new Regulations being fully in force if those devices comply with the Regulations rather than with the relevant Directives:

"Elements of the new regulations have been applied directly in UK law since May, meaning devices can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. As it stands, the EU (Withdrawal) Bill would maintain this position beyond March 2019.

I think it is important to make this clear for everyone involved in the sector, as your preparations to meet the requirements of the new EU regulations are already well underway. I hope this provides some certainty. "

Whilst it is technically correct that the EU (Withdrawal) Bill will maintain the position that devices can be legally placed on the market if CE marked in compliance with the new Regulations under those articles, because the vast majority of the provisions of the Regulations will not be applicable or in force, there is significant potential for even greater uncertainty for device manufacturers relying on the Regulations to regulate their medical devices in the UK after 29 March 2019.

I discussed this point with John Wilkinson, head of the medical devices division at the MHRA, and he assured me that the Government are aware that the EU Withdrawal Bill does not in current form bring onto the UK statue book the majority of the provisions of the Regulations, and that "there are lots of civil servants working on this problem", in order to achieve the goal of the Regulations becoming part of UK law. 

We will have to wait and see what solution this team of civil servants comes up with to solve the fact that the EU (Withdrawal) Bill as drafted does not provide for most of the provisions of the Regulations to become part of UK law.

Hopefully they will at the same time be determining how the significant amount of secondary legislation that is yet to be published by the EU Commission pursuant to the Regulations will also become part of UK law.

3. Will there be full regulatory mutual recognition between the UK and the EU for the regulation of medical devices?

Full regulatory mutual regulation would mean that the certification by a notified body in the UK would be recognised in the EU and vice versa. This is currently the position as between the EU and Switzerland for medical devices.

Full regulatory mutual recognition would avoid the headache for companies with devices certified by notified bodies in the UK (of whom there is a substantial number) having to obtain an additional and separate certification by a notified body in the EU27. Notified bodies have significantly decreased in number over recent years and are overstretched.  This situation is set to become more serious as they have to recertify under the Regulations devices that they have previously certified under the current three medical device directives, as well as devices which have not previously required certification.  The five UK notified bodies are responsible for the certification of a very large proportion of medical devices placed on the EU market. Therefore, as a practical matter for patients, regulators and the industry, the ability for UK notified bodies to certify devices bound for the EU27 would be a very positive step.

The "noises" from government seem to indicate in a non-committal manner that this might be their preference. However, whether the close (even "warm") regulatory relationship does actually materialise is very much dependent upon the outcome of the wider political negotiation, currently stuck in phase I.

If relations are warm and "closer", and the outcome of the negotiation on many matters are more along the lines of Norway, or even Switzerland, rather than that with Canada, then perhaps mutual recognition might be achievable. Obviously in a no-deal situation, mutual recognition would not be possible immediately upon exit, but might be possible at a later date if the UK does enact the Regulations, and if longer term we were to engage in on-going negotiations on the point.  This will though be too late to avoid the imminent notified body crisis.

4. What should medical device companies do?

In order to clearly determine their regulatory strategy, medical device companies selling their products in the UK and EU27 will rather obviously need to know what the law is that they have to comply with. This certainty is currently non-existent for the UK market after 29 March 2019.  It seems unlikely that clarity on this will be provided any time soon. 

Companies desiring certainty in their regulatory strategy therefore need to prepare for a hard Brexit. A hard Brexit on 29 March 2019 will necessitate having a notified body in the EU27 and a separate notified body in the UK.

There are a few potential scenarios for medical device companies to consider, depending on where their products are in the regulatory cycle and the location of any current notified body:

1. Medical device companies looking to obtain notified body certification for a new product might consider using a UK notified body, but through one of their subsidiaries based in the EU27. Then, if a hard Brexit is the reality, one might hope that the notified body's colleagues in the UK parent company might be willing to recognise the certification work already undertaken for the device, and to relatively straightforwardly provide the same certification for the UK as a separately regulated market. No promises though on whether or not double the certification fees will be charged for this!
2. Companies seeking a recertification under the Regulations for a CE marked medical device already on the market and whose current notified body is not a UK one, will want to weigh up the benefit of taking the course suggested in point 1. above, against the cost of losing the benefit of the know-how of their current notified body. In making this decision, companies will want to consider the importance of being able to sell immediately into the UK market upon Brexit as against the EU27.
3. For companies with current certifications with UK notified bodies, there is the option of transferring these certificates to one of the EU27 subsidiaries of that notified body. Companies will need to consider the timings for obtaining a transfer, plus a second certification for the UK as at 29 March 2019, so that there is as little interruption as possible to these two markets for their products.
4. For companies with current certifications with notified bodies based in the EU27 and who will not be seeking a recertification under the Regulations, if the UK market is important, then an opening discussion with a UK notified body in particular around timelines for a separate UK notification should be had so that preparations can be made in a timely fashion in advance of 29 March 2019.

Note that the current Medical Devices Directives do not permit companies to undertake parallel negotiations with two notified bodies for the same certification. Therefore in strictly legal terms, discussion of a second certification for the UK or EU27 (as applicable) will need to be speculative only and on the basis that it will not be the same certification as that already held in the other regulatory jurisdiction.