The transfer of CML’s ATEX certificates to the Netherlands

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As I described in my last post, all eight UK ATEX Notified Bodies have taken steps to establish an ATEX NB operation in the EU27, and so far five of them have completed the process, beginning with Certification Management Limited (CML), while the remaining three are only one short step away from doing so. In this article, I outline in a little more detail the establishment of CML B.V. (Netherlands) as an EU Notified Body, and attempt where possible to trace the transfer of certificates to it from CML UK or other UK NBs.

Certification Management Limited was taken over by Eurofins Scientific (headquartered in Luxembourg) in January 2019, and is now called Eurofins E&E CML Limited. The Dutch CML B.V. is a subsidiary of the UK company. CML B.V. achieved accreditation by the Dutch Accreditation Council in March 2018:

to carry out a full range of conformity assessment procedures (continuing for 7 pages of the schedule) under the ATEX Directive:

CML BV became an ATEX Notified Body two months later on 17 May 2018:

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No deal readiness for ATEX equipment (for potentially explosive atmospheres)

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Equipment for use in potentially explosive atmospheres in the EU has to meet the requirements of the ATEX Directive 2014/34/EU:

As one might expect given the nature of the risk, the requisite conformity assessment procedures for such equipment generally includes involvement by a third party Notified Party. The only exception is Category II.c, where only a ‘normal’ level of protection is required, and the probability of an explosive atmosphere is low (Annex I, 2.c):

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Is the European Commission right about certificate validity?

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On 22 January 2018, the European Commission issued a notice to the effect 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:

This announcement flew in the face of the Commission’s own guidance in the ‘Blue Guide‘ (5.3.4):

that certificates retain their validity, unless positive demonstration can be made that they should be withdrawn. EU legislation contains no provisions for the status of certificates previously issued by Notified Bodies which have lost their notified status, as pointed out for example by the French National Agency for the Safety of Medicines and Health Products (ANSM) stated in October 2016:

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

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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?

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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

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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).

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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).

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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)

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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)

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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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