The transfer of UL UK’s medical device EC Certificates to Poland

In my penultimate post, I discussed the closure of Lloyd Register’s medical devices Notified Body operation, announced on 13 June 2019. Less than three weeks later, on 1 July, the UK subsidiary of Underwriters Laboratories, announced that it too was closing its medical devices Notified Body operation, with effect from 1 September 2019:

Whereas Lloyd Register has ceased its medical device Notified Body work altogether, however, UL had entered into a ‘partnership’ with the Polish Notified Body PCBC (Polskie Centrum Badan I Certyfikacji):

to which 80% of certificates had been transferred, with the remainder having gone to another unspecified EU27 Notified Body:

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Why did SGS UK apparently not begin to transfer its medical device certificates to Finland and Belgium earlier this year?

I am continuing my series on medical devices currently certified for the EEA market by Notified Bodies established in the UK. For the sake of simplicity, I am confining myself to products covered by the Medical Devices Directive (MDD) rather than the IVDD (In Vitro Diagnostic Medical Devices Directive) or the AIMDD (Active Implantable Medical Devices Directive). 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.

As I discussed in my last post, Lloyds Register closed their medical devices notified body operation last month, leaving their clients little time to transfer their certification to another NB. BSI appear to have the matter well in hand, having established an operation in the Netherlands at the end of last year and having urged their clients early this year to take advantage of the opportunity to transfer their certification to that new NB. In this post, I examine the situation with SGS UK, SGS being reportedly the world’s largest testing, inspection and certifying company, headquartered in Switzerland.

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The closure of Lloyds Register’s medical devices Notified Body operation

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.

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Technical Barriers to Trade in the event of No Deal: Notified Bodies (3/4): Migration of BSI medical device certificates to the Netherlands (3d).

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.

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Technical Barriers to Trade in the event of No Deal: Notified Bodies (3/4): Current ‘grace period’ arrangements for medical devices (3c).

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.

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Technical Barriers to Trade in the event of No Deal: Notified Bodies (3/4): Is the Commission being consistent? (3b)

The European Commission has stated that, in the event of No Deal, product safety certificates issued by UK Notified Bodies (NBs) will become invalid for products placed on the EU-27 market after the withdrawal date:

In response, UK NBs have been seeking notified status in the EU-27 through a subsidiary or other arm of their company or organisation. In my last post, taking medical devices as an example, I examined how far this process has progressed. The largest UK medical devices NB, BSI, achieved notified status in the Netherlands in November 2018, and began transferring certificates across to its Dutch subsidiary. Lloyds Register and SGS UK are part way through the process, while UL UK do not appear to be making any such No Deal preparations.

While some manufacturers may have acted independently after the UK’s decision to leave the EU, and transferred to a different company already notified in the EU-27, it would appear from certificates currently available online that many have stayed with their UK NBs. As things stand, therefore, a No Deal withdrawal could result in an immediate loss of market access for many medical devices, with potentially serious consequences for recipients of medical services in the EU-27, and for manufacturers worldwide.

SGS, the world’s largest, Testing, Inspection and Certification company, have remained sanguine, describing the Commission’s position as ‘extreme’, and expressing confidence that the EU-27 will adopt a ‘more pragmatic position’ and allow UK NB certificates to continue to be recognised while they are being transferred to EU-27 bodies:

In this short post I:

i) show that EU product safety legislation does not contain provisions which specify the status of certificates issued prior to a denotification;

ii) argue that current Commission guidance indicates strongly that there should be no immediate loss of validity of such certificates.

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Technical Barriers to Trade in the event of No Deal: ‘Notified Bodies’ (3/4): Readiness (3a)

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.

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Technical Barriers to Trade in the event of No Deal: Importers (2/4)

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.

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Would UK regulatory divergence hinder our exports to the EU? (1/4)

On 6 December 2019, ‘The UK in a Changing Europe’, an ESRC-funded ‘Initiative‘ at King’s College London, published a report on the implications of trading under World Trade Organisation (WTO) rules (without a Free Trade Agreement or Customs Union with the EU) in the event of a no deal Brexit. Chapter 7, by Sam Lowe of the Centre for European Reform, concerns non-tariff barriers to trade under WTO trading: 1

My purpose here is to address Lowe’s first question:

I confine 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.

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Notes:

  1. As is customary, I use ‘WTO trading’ as a shorthand for trading under WTO rules without a GATT Article 24(8) customs union or free trade area.

Learned opinion against the High Court Judgement

Introduction: why are Government ‘sources’ predicting failure?

On 4 November 2016, the day after the High Court had handed down its judgement that the Government ‘does not have power under the Crown’s prerogative to issue the Article 50 notification’, the Prime Minister’s spokesman said that ‘the focus of the government’ was on the Supreme Court appeal, and that they remained ‘confident of winning that case and proceeding with Article 50’.

On 7 November 2016, David Davis told Parliament that the Government disagreed with the High Court’s judgement, that their position remained that ‘triggering Article 50 is properly a matter for the Government using its prerogative powers’, and that they would therefore be appealing the judgement at the Supreme Court.

On 1 December 2016, John Finnis, Emeritus Professor in the Faculty of Law at Oxford University, in his Thomas More Lecture at Lincoln’s Inn Fields, four days before the Supreme Court hearings and therefore presumably on the basis of the Government’s written submission, said that ‘the principle of constitutional dualism at the intersection of international affairs with domestic law’ had ‘been presented much more clearly and fully’ than it had been to the High Court, intimating that he had not given up hope of a reversal of the decision.

I find it odd therefore that Government sources were reported by the Guardian on 11 January 2017 to be ‘convinced’ that ‘seven of the 11 judges will uphold the high court’s’ judgement. Why the defeatism?

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