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:
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):
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that certificates retain their validity, unless positive demonstration can be made that they should be withdrawn.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:
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:
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.