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.
The legal position
EU product safety legislation specifies that a Notified Body will lose its notified status if it ceases to fulfil the necessary criteria, as may be illustrated by the Medical Devices Directive 93/42/EEC and Article 16(2)-(3):
It does not however specify whether certificates issued by such NBs prior to their denotification remain valid or lose their validity. In a Best Practice Guide entitled ‘Change of Notified Body’ issued in November 2008 by the Notified Body Operations Group (NBOG), a body specific to the medical device sector, it is stated that there are no provisions in the relevant Directives or detailed information about how to proceed when a manufacturer changes their Notified Body, whether by choice or necessity:
Similarly the French National Agency for the Safety of Medicines and Health Products (ANSM) stated in October 2016 that the European regulations do not lay out the consequences of denotification:
The European Commission’s ‘Guide to the Implementation of Directives Based on the New Approach and the Global Approach’, 2000 edition, did address the consequences of denotification on existing certificates:
The current edition of the Blue Guide contains similar guidance:
Certificates issued by Notified Bodies prior to their notification do not lose their validity until such time as it can be positively shown that they should be withdrawn.
Why then has the Commission decided that certificates issued by UK Notified Bodies will lose their validity immediately in the event of a No Deal Brexit? Is this decision not at variance with the Commission’s own guidance?
It may be arguable that, in context, the guidance concerns the denotification of a conformity assessment body established in a country that continues to be an EU member state. The following sentence reads:
The ‘notifying Member State’ is given a role in ensuring continuity. Since the UK would no longer be a Member State, it would no longer be able to fulfil the role as stated. Perhaps it could be argued then that the whole paragraph is inapplicable to this case of a state withdrawing from the EU.
On the other hand, the continued validity of certificates is stated in the first sentence in unconditional terms: the ‘withdrawal of a notification does not affect certificates issued by the notified body up to that point..’.
Moreover, the underlying principle, to the extent that it may be discerned, would probably still apply. Surely the Commission must be basing its guidance on the thought that the conformity assessment body was properly notified at the time that it issued the certificate. This is true of the certificates issued by UK Notified Bodies.
Indeed, the principle would seem to apply a fortiore in the case of UK bodies. The section in which the paragraph occurs concerns the competence of Notified Bodies:
Although other grounds for suspension or withdrawal of Notified Bodies are discussed in the section, lack of competence is the primary one. Even when a body is denotified because of incompetence, the certificates it has issued previously retain their validity, until there is a positive demonstration that they must be withdrawn, even though there are legitimate grounds for concern, since current incompetence may indicate past incompetence.
The denotification of UK bodies in the event of a No Deal Brexit, however, bears no reflection on their competence. It is a purely legal matter, and there are no immediate grounds for concern about the safety of the products they have certified. Why then is the EU intending to use its product safety legislation to prevent access of UK NB certificated products to its market, immediately upon UK withdrawal, despite the absence of product safety concerns?