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.