Is the European Commission right about certificate validity?

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that certificates retain their validity, unless positive demonstration can be made that they should be withdrawn.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

The product itself, of course, would not immediately become more dangerous the day after a No Deal Brexit. In the case of medical devices at least, SGS reports that the Dutch Competent Authority has announced that they will accept UK certification for a limited period:

apparently disregarding the Commission’s notice that the certificates will become invalid. It has every right to do so under EU law so far as I can see.

Annex I of Decision 768/2008/EC ‘on a common framework for the marketing of products’ outlines the structure of community harmonisation product legislation. Article R31 gives the procedure for products presenting a risk at national level. A Member State with concerns about a product is to ‘carry out an evaluation’, and then require the relevant economic operator – the importer in this case – to take ‘appropriate corrective action’, or to recall it ‘within a reasonable period, commensurate with the nature of the risk’:

No sudden cut-offs are in view here, if the risk is moderate. The procedure takes the following form in the ATEX Directive (2014/34/EU), for example:

This is measured. A risk could arise over a period of time. The conformity assessment Modules require ongoing involvement by the Notified Body, in the form of audits, inspections, monitoring of technological changes that could affect the viability of the product, and so on. The absence of these would create a risk, over a period of months, certainly of years. But it would likely take between 3 and 9 months to transfer certification to a Notified Body in the EU27. The risk seems moderate. Very possibly, the manufacturer would in fact continue its involvement with its now denotified certifier until the new arrangement was in place. If it did, then this would surely greatly reassure any Member State that had concerns. The denotification would not affect the certifier’s accreditation with UKAS for the tasks concerned, and UKAS is continuing as a member of European Accreditation until at least 2021, so there should be no change in the quality of oversight in this eventuality.

Thus an admittedly cursory examination of EU product legislation seems to confirm the still current Blue Guide guidance that (5.3.4):

the suspension or withdrawal of a notification does not affect certificates issued by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.

A manufacturer can continue to produce a product which holds such a certificate, and continue to place it on the market, even though the previously Notified Body has lost its notified status.

The Commission claim in their Notice of January 2018 that:

a certificate delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market will be required..

While there would be no need to withdraw products that had already been placed on the market, no further products could be placed on the market once the Notified Body had lost its notified status.

The Commission’s Notice seems to be incompatible with its guidance. It cannot have it both ways. The UK should challenge the Commission to explain the inconsistency. If the Commission cannot justify its new position, then it must withdraw its Notice.

Andrew Chapman

2 thoughts on “Is the European Commission right about certificate validity?”

  1. “The UK should challenge the Commission to explain the inconsistency. If the Commission cannot justify its new position, then it must withdraw its Notice.”

    Your blog has excellent content, but can you clarify ‘must’ here? You mean they are morally obliged to, or something else?

  2. Hi Alan, yes I mean I suppose that the Commission has a moral obligation to abide by its own law and guidance, especially since the effect of their current policy would be to create unnecessary problems, for both manufacturers and consumers.

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