On 13 June 2019, Lloyd’s Register announced that it would no longer be providing medical device Notified Body services:

citing unspecified ‘recent market developments’. As well as closing its UK medical device Notified Body operation, it was also withdrawing its application for medical device notified status in the Netherlands:

As it happens, I heard the news yesterday from medical device manufacturers holding Lloyds Register EC Certificates who I had contacted to enquire about their No Deal Brexit preparations. Their current certificates will now expire on 30 September 2019. But one told me that in such a case where a certificate is soon to expire, the transfer to a new Notified Body takes 6-9 months. They therefore appeared to be faced with a loss of access to the EU27 market.

Continue reading →

In my last three posts I have been examining the barriers to trade that could arise in the event of No Deal as a result of the UK Notifed Bodies’ loss of notified status. The European Commission announced in January 2018 that certificates issued by UK Notified Bodies will lose their validity immediately upon the UK’s withdrawal from the EU, in the absence of transitional arrangements. In part 3a, taking medical devices as an example, I looked at the efforts made by UK Notified Bodies to gain the required notifications in branches situated in EU-27 member states, so that existing certificates can be transferred across, and new certificates issued. I concluded that BSI, the largest of the four main UK medical device NBs, has probably largely completed this process. Lloyds Register and SGS UK have the process underway but not yet completed. I found no definite indication that Underwriters Laboratories are attempting to achieve notified status for medical devices in the EU-27. While some manufacturers may have taken action to migrate their certificates to other companies or organisations with notified status in the EU-27, the impression I have gained is that many have preferred to remain with their current notified body. If this is correct, then products certified by Lloyds Register, SGS UK and UL UK would, as things stand, lose access to the EU internal market immediately in the event of No Deal.

In part 3b, I drew attention to longstanding Commission guidance that certificates previously issued by a notified body would not immediately lose their validity if the body ceased operation; and in 3c, I detailed more specific guidance currently in operation to allow a grace period of up to a year in the medical device sector for ‘orphaned’ certificates of this sort. Arguably, therefore, the Commission’s decision with regard to Brexit is in contradiction to its own guidance, and to current practice in the EU.

Nevertheless, the decision has been taken, making it necessary to try to assess the consequences of it being put into effect in the event of No Deal. I will show in this and subsequent posts that a remarkably high proportion of medical device manufacturers worldwide, including within the EU-27, have employed UK NBs to certify their products.

Continue reading →

The European Commission announced in January 2018 that certificates issued by UK Notified Bodies will lose their validity immediately upon the UK’s withdrawal from the EU, in the absence of transitional arrangements. In my last post, I pointed to Commission guidance that certificates issued by a Notified Body should not lose their validity immediately in the event that it ceased operation, and asked why it was adopting a different approach with respect to UK Notified Bodies and Brexit. In this post, I describe the detailed arrangements that are currently in place to allow medical devices to continue to be marketed in the EU for a ‘grace period’ when a Notified Body ceases operation, and ask whether there is any good reason why similar arrangements should not be adopted in the event of a No Deal Brexit.

Continue reading →

I am responding to a claim made by Sam Lowe that new non-tariff barriers to trade would be ‘highly disruptive’ in the event of a No Deal Brexit. I am confining myself to those technical regulations which come under the WTO Technical Barriers to Trade (TBT) Agreement, rather than those covered by the WTO Agreement on Sanitary and Phytosanitary Measures. Like Lowe, I see three types of TBT barriers arising:

i) An EU ‘importer’ would be required (see part 2), who would have a responsibility to carry out checks that the manufacturer had carried out the necessary conformity procedures.

ii) UK ‘Notified Bodies’ will lose their notified status, and the certificates they have issued will lose their validity.

iii) UK exports to EU-27 would be subject to regulatory checks at the border.

In this post, I begin an examination of the difficulties that may arise in connection with UK Notified Bodies.

Continue reading →

I am responding to a chapter by Sam Lowe on non-tariff barriers to trade in a report on the implications of trading on WTO terms in the event of a No Deal Brexit. I am confining myself to those technical regulations which come under the WTO Technical Barriers to Trade Agreement, rather than those covered by the WTO Agreement on Sanitary and Phytosanitary Measures. I began in Part 1 by addressing the question, raised in the chapter’s heading, as to whether regulatory divergence would give rise to technical barriers to trade. I argued that if the UK regulations diverged from the EU after Brexit, this could create challenges for manufacturers, wherever based, to overcome in producing goods that satisfied the new regulations. These differences in regulations could be considered to be barriers, or hurdles, to the UK market, but hardly to the EU-27 market.

Continue reading →