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.

Continue reading

The EU-US MRAs (part 2): agency recognition as an alternative to MRAs

In my last post I traced the origins of the 1998 EU-US MRA on conformity assessment back to the Internal Market program of 1985-92 and its New Approach to product safety legislation. In accordance with the Community’s obligations under GATT, and the GATT Standards Code in particular, both the essential requirements that products had to meet, and the assessment procedures laid down to demonstrate their conformity with those requirements, were formally exactly the same for all products, whether imported or produced in Member States. The potential problem for third countries was that the third party conformity assessment bodies (CABs), whose involvement was necessary for some products, were designated by Member States and might naturally be expected to be established in the same Member State. Would it therefore be necessary for third country manufacturers to send their products to laboratories in the Community for type approval? And where the procedures required inspection of the manufacturing facilities and quality control systems, would inspectors have to come from Europe to carry them out, at considerable expense to the manufacturer?

Continue reading

Conformity assessment and the WTO option (part 3): testing in third countries

In my previous two posts (here and here), I have been examining the concern that has been expressed, notably by Andrew Tyrie MP, about the obstacles UK manufacturers might face in exporting to the EU under the WTO option, because of the need to ensure that their products continue to conform to EU product legislation, and because of a need moreover to be able to prove that conformity. I have been confining myself to products covered by the New Approach legislation, and have focussed on the form which that legislation has taken since the introduction of the New Legislative Framework in 2008. My main conclusions so far have been that:

Continue reading

Conformity assessment and the WTO option (part 2)

In my previous post, I introduced the concern that has been expressed, notably by Andrew Tyrie MP, about the obstacles UK manufacturers might face in exporting to the EU under the WTO option, because of the need to ensure that their products continue to conform to EU product legislation, and because of a need moreover to be able to prove that conformity. I am confining myself to products covered by the New Approach legislation, and have focussed on the form that legislation has taken since the introduction of the New Legislative Framework in 2008. The main points were:

Continue reading