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Focus on Regulation

Brexit, medical devices and transfer of notified bodies. What will be the procedure?

In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common rulebook” between the parties in relation to goods. The White Paper discusses what is foreseen as the future relationship between the parties in some detail. This includes the expectation that goods’ manufacturers should be required to undergo only one series of tests in either the EU or the UK, in order to place products in both markets. According to the White Paper, this approach would be “underpinned by strong reciprocal commitments to open and fair trade and a robust institutional framework”.

Among the aspects of the future relationship would be:

“accreditation of conformity assessment bodies – testing the testers within a jointly agreed accreditation framework, to provide mutual reassurance that UK and EU conformity assessments are robust”.

The White Paper adds that the Parties would continue to “recognise the activities of one another’s type approval authorities”.

For the medical device industry, the practical implications of the aims and expectations expressed in the White Paper could lead to two alternative conclusions:

i) UK notified bodies would, in essence, continue to be considered EU notified bodies. In practical terms, the UK notified bodies would issue CE Certificates of Conformity on the basis of applicable EU laws equivalent to those issued by notified bodies in the 27 EU Member States.

ii) The EU and the UK would agree to mutually recognise the certificates (either CE Certificates of Conformity or UK Certificates of Conformity) issued by notified bodies licensed to operate in their territory. The practical effect of this approach could be that, while medical devices covered by a UK Certificate of Conformity could be exported to and marketed in the EU, UK notified bodies would be unable to issue CE Certificates of Conformity based on EU law. This may lead to obstacles to the marketing of the devices in the EU, e.g. in access to public tenders in the 27 EU Member States.

If the EU and the UK were unable to find an agreement concerning the terms of Brexit, manufacturers currently working with UK notified bodies would be required to either change notified body or to transfer their CE Certificate of Conformities to another entity established by their notified body in one of the 27 EU Member States. In the latter case, the newly created structure of the notified body would be required to be “designated” or in simple terms licensed by the competent national authority in accordance with the current medical devices Directives and, in the future, with the MDR and IVDR to operate as a notified body. If designated under the Directive and then the MDR and IVDR in one of the 27 EU Member States, the new EU notified body which is an affiliate of a UK notified body is unlikely to be able to retain its existing UK notified body number. The new EU notified body will, therefore, receive a new notified body number. This change would need to be reflected on the labelling of and in the Instructions for Use of medical devices for which the entity is the notified body.

The regulatory basis on which a transfer of CE Certificate from an existing UK notified body to a new notified body in one of the 27 EU Member States is a matter for discussion.

Available guidance

In 2006, the Notified Body Operations Group (NBOG) developed a guidance document Change of Notified Body (NBOG BPG 2006-01) that may provide support in understanding transfers of notified body resulting from Brexit. The Guidance is intended to:

“provide manufacturers, Notified Bodies and Competent Authorities with guidance on the procedures that need to be taken into account when there is a change in the manufacturer’s Notified Body”.

The Guidance distinguishes between voluntary and enforced or involuntary transfers of notified body.  This distinction is important as the procedure which must be followed by manufacturers and notified bodies differs according to the nature of the transfer.

In the circumstances of a “Voluntary” change:

“The manufacturer (applicant) parts with the NB although the NB is able to continue to provide its service, or the NB parts with the manufacturer although he continues to produce the devices the NB has certified (dissolution of service agreement).”

An “Enforced/Involuntary” (unintended) change occurs where:

“The NB is no longer able or authorized to offer its service, either completely or partly (breakdown of NB).”

With a hard Brexit, UK notified bodies would lose their right to conduct conformity assessment in accordance with EU rules in relation to medical devices. The CE Certificates of Conformity issued by these notified bodies before 29 March 2019 would also cease to be valid. In these circumstances, it could be argued that any resultant transfer of notified body would be enforced rather than voluntary. The Guidance provides that, in the situation of an enforced transfer, the relevant competent authorities have an important role to play in relation to the transfer:

“The Competent Authority also has to take appropriate steps to ensure that another NB is taking over the tasks and – depending on the nature of the de-designation – to ensure that appropriate transfer measures are taken as well as time limits kept. The previous NB should provide all relevant information and materials to the manufacturer’s new NB to ensure a smooth transfer of the responsibilities for the conformity assessment.

In the above mentioned cases CAs may allow the manufacturer to place devices on the market for a certain time with the identification number of the previous NB although this NB does not offer its service any longer or is no longer existent”

The NBOG Guidance then distinguishes between circumstances in which the breakdown of a notified body is foreseeable and the situation where this breakdown in not foreseeable.

This is an important analysis as the conclusion will, in part determine whether a new certificate may be issued solely on the basis of the documentation held by the UK notified body (foreseeable breakdown) or whether a new conformity assessment which will include a review of the manufacturer’s documentation and/or a site visit by the new notified body may be necessary. Obviously the impact for manufacturers will be completely different.

This gives rise to two questions:

  • Can manufacturers legitimately rely on the NBOG Guidance to anticipate the consequences of Brexit for their activities in the EU?
  • Will UK notified bodies and competent authorities consider the consequences of Brexit as foreseeable?

Some clarification would be really useful.