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. In my last post, I pointed to Commission guidance that certificates issued by a Notified Body should not lose their validity immediately in the event that it ceased operation, and asked why it was adopting a different approach with respect to UK Notified Bodies and Brexit. In this post, I describe the detailed arrangements that are currently in place to allow medical devices to continue to be marketed in the EU for a ‘grace period’ when a Notified Body ceases operation, and ask whether there is any good reason why similar arrangements should not be adopted in the event of a No Deal Brexit.
The Competent Authorities for Medical Devices (CAMD), an EU umbrella group, met in Slovakia on 17-19 October 2016. According to the French Competent Authority, the National Agency for Medicines and Health Products Safety (ANSM), the group agreed guidelines on the management of the situation created by the denotification of a notified body:
Although the CAMD guidance does not appear to be publicly available, its outlines can be traced from two subsequent national implementations of the guidelines.
On 24 October 2016, just a week after the CAMD meeting, the French National Agency for Medicines and Health Products Safety (ANSM) issued an information bulletin and a Q & A document on the de-notification or termination of notified bodies’ (“NB”) activities. An English version was released on 14 November 2016.
It began by stating that several notified bodies had ceased operation in the previous several months:
The PIP scandal
The reason is not stated, but can be traced to the PIP breast implant scandal, which broke in March 2010, when the French Competent Authority (then the AFSSAPS) recalled silicone gel breast implants manufactured by the French Poly Implant Prothèse (PIP) company, who had been fraudulently substituting industrial grade silicone for medical silicone.
In February 2012, the European Commission agreed with EU Member States a Joint Plan for Immediate Actions to be taken to strengthen controls under the existing medical device Directives, pending new legislation.
In October 2012, after an undercover investigation conducted jointly with the prestigious BMJ (British Medical Journal), the Daily Telegraph exposed the shocking weakness of the EU’s medical devices regulatory system (here, here, here, and here).
ITC, a Notified Body in the Czech Republic, told the reporters, who were posing as representatives of a medical device company, that they were ‘on the side of the manufacturer… not on the side of patients’:
An employee of ITC’s arm in Seoul, South Korea, told the undercover team that the EU system was ‘easier’ than the US one, because the certifiers were paid by the manufacturers and so had an interest in granting approvals:
Dr Carl Heneghan, Centre for Evidence-Based Medicine at the University of Oxford, wrote for the Telegraph that the EU system
now heavily favours manufacturers at the expense of patient safety.
Re-assessment of notified bodies
Meanwhile member states had been conducting re-assessments of the notified bodies under their jurisdiction which were designated for high risk devices, resulting in corrective measures or scope limitations for NBs in at least 8 countries, and in one NB withdrawing altogether from high risk medical device work:
Then in February 2013, joint assessments of notified bodies, undertaken by a team drawn from the Commission and member states, began on a voluntary basis. In September 2013, Commission Regulation (EU) 920/2013 ‘on the designation and the supervision of notified bodies’ under the medical device Directives was adopted. Among other matters, it put joint assessments on a legal basis (Article 3(2)):
58 joint assessments had been done (p. 6) by the end of 2016:
Six designations were withdrawn as a direct result of the joint assessments. But the indirect impact seems to have been greater still, since in 19 cases no joint assessment was carried out, either because of a voluntary withdrawal by the notified body, or because of a decision by the national authority (p. 10):
Out of 78 medical device notified bodies in October 2013, 25 were no longer operating in mid-2017:
Even if it was in general the smaller and less well established notified bodies that were ceasing operation, it can be seen that CAMD were addressing a major issue at their October 2016 meeting, with many products being ‘orphaned’, that is to say being no longer under notified body supervision.
The ANSM’s guidance of October 2016 applies to denotifications resulting from decisions made by Competent Authorities, and to voluntary decisions made by notified bodies to cease operations:
In the event of No Deal, the MHRA (Medicines & Healthcare products Regulatory Agency) would cease to be a Competent Authority under EU law, and therefore would be unable to withdraw the notification. The medical device Directives do not appear to make provision for any other method of denotification, the Medical Devices Directive 93/42/EEC, for example, providing only for action by Member States (Article 16(3)):
In lieu of denotification by a member state notifying authority, the European Commission announced in January 2018 that, since they would no longer meet the required conditions, UK Notified Bodies would lose their notified status upon the UK’s withdrawal from the EU, and be removed from the NANDO database:
In effect, they would apparently be denotified by the Commission rather than by a member state.
It seems to me that it is unclear whether the French guidance would apply to UK Notified Bodies which lost their notified status due to the UK withdrawal from the EU. While such an eventuality is not specifically mentioned, nothing can be read into the absence of mention of a procedure for denotification that did not yet exist in 2016.
Which manufacturers can benefit from the French guidance?
The guidance contained in the ANSM’s Information Bulletin of October 2016 appears to apply to all manufacturers, wherever located:
The accompanying Q & A, however, specified that the procedures apply only to manufacturers headquartered in France:
This more specific information might normally take precedence. The question is made less certain, however, by the apparent absence of the Q & A from the ANSM’s current list of publications in English, raising the possibility that it has been withdrawn, and only the Bulletin retained.
A 12 month grace period
The ANSM decided that a manufacturer, after its products had been orphaned, could, if certain conditions were satisfied, continue to market them for a period of 12 months, or until the expiry date of the certificate, whichever was shorter:
The manufacturer would have to provide a list of the affected medical devices along with their certificates, a statement to the effect that they continued to comply with the necessary requirements, and evidence that steps had been taken to migrate them to a new notified body:
The application should be sent to ANSM:
If the application were successful, then access would be granted to the entire EU market:
The Dutch guidance
Similar guidance has been issued by the Dutch Health and Youth Care Inspectorate. It assumes that any denotification has been carried out by a Competent Authority:
The guidance applies specifically to manufacturers and Authorised Representatives headquartered in The Netherlands:
The grace period is again limited to a maximum of 12 months:
The conditions are similar to those imposed by the French authorities, but are perhaps somewhat more specific and detailed:
The products are considered to be under the ‘temporary supervision’ of the inspectorate until they are transferred to a new notified body:
A practical approach
I considered the question of the validity of existing certificates issued by UK notified bodies in an article posted on 30 September 2016, less than three weeks before the CAMD meeting in Slovakia. I pointed out that products will not suddenly become less safe the day after the UK leaves the EU:
On the other hand, if the previously notified body were unable to continue with its supervisory role, then there would be genuine safety concerns in the longer term. I suggested therefore that one possible solution would be to allow existing certificates to continue to be used for up to one year, while the products were migrated to EU-27 notified bodies:
The same approach was agreed by the competent authorities meeting in Slovakia the next month. It seems to be me to be eminently practical. Is there any good reason why the EU should not adopt it?