+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Medical devices: the latest progresses in the post-Brexit scenario

The United Kingdom (UK) officially left the European Union on 1st February 2020. This decision resulted in the so called ‘transition period’, whose end has been fixed on 31 December 2020. The turmoil still existing at European and extra-European level on the topic of Brexit has brought significant developments. This article will examine some of them in depth.

First of all, it should be specified that, even if some of the consequences on the medical device market depend on the outcome of the ongoing negotiations between EU and UK, the impact of other measures taken by the United Kingdom will be immediately effective and inevitable, also considering the less and less remote possibility of a “Hard Brexit”.

The European Commission has just released communication COM (2020) 324, aiming at defining the measures to be worked on until the end of the transition period and avoid to be unprepared when the deadline expires. For instance, European products intended for exportation to the UK will be subject to controls by local authorities and shall comply with all locally valid legal provisions, since the European law will be no more applicable. Similarly, the consequences of Brexit will also fall on those distributing medical devices coming from UK, that will be considered as importers according to the European laws, with consequential application of the related obligations.

As for the notified bodies located in the United Kingdom, the validity of the certificates they released will end with the transition period, and they will be no more authorised to release new certificates according to the European regulations and directives. Many concerned notified bodies have already started to change their organisation, creating or using other headquarters located on the European Territory.

The position of the United Kingdom

The position of the United Kingdom is being defined along with the progress of the work and consultations at the European Commission, so that on 1 September a guideline was published on the official website “GOV.UK”, describing the measures and changes that are being taken to market medical devices in the UK. Different rules are provided for Northern Ireland. It should be said that the contents of the guideline will become binding only when they become law.

The surveillance of the market regarding medical devices will continue to be carried out by the MHRA (Medicines and Healthcare products Regulatory Agency), but the conformity requirements and the product marking will change, starting with the introduction of the Ukca marking on MDs. MHRA will also be entrusted with the designation of “UK Approved Bodies” (corresponding to the EU Notified Bodies and with the registration of medical devices. On this last point, the timelines for the registration of the MDs at the MHRA have already been defined:

  • 30 April 2021 for class IIIs and active implantable devices
  • 31 August 2021 class IIa/IIb devices
  • 31 December 2021 for class I devices

The way registrations should be carried out has not been defined yet, however it is likely that a registration will be requested to everyone wishing to sell in UK (not only manufacturers located in the UK), and that the responsibility will fall on importers, or on the “UK responsible person”.

Another factor to be considered is the imminent full application of Regulation 2017/745/EU, that will also condition the UK regulatory landscape. The Government has been in fact preparing the update of the law called “The Medical Devices Regulations 2002” to bring it in line with the MDR.

A new role has been introduced, the “UK responsible person”, whose appointment will be required for manufacturers located outside UK. Just to mention some of their tasks, the responsible person shall control and store the technical documentation, making sure that it meets the legal obligation and will interface with the manufacturer taking care of its relation with and any request from the Authority.

The Ukca brand and new UK regulatory requirements

The new UK requirements will apply as of 30 June 2023, after a transition period starting on 1 January 2021. During this period, manufacturers can adopt several approaches for the marketing: CE marking and conformity certificates will be valid in the United Kingdom throughout the transition period, so that manufacturers will not need to differentiate the MDs sold in UK from those sold in the EU during the transition period.

In contrast, the sole presence of the Ukca marking will only allow the marketing of MDs in the UK: for this reason, manufacturers will be authorised to put the CE marking concomitantly, and to continue their economic activities in the EU territory as well.

Written by: Riccardo Del Signore

Foto di stux da Pixabay