As of 1 January 2021, United Kingdom is no more a Member of the European Union. Every sector was affected in a different way by this event, and a relevant impact is also found in the sector of medical devices.
On 31 December 2020, the UK Ministry of Health (MHRA) published a new guideline on how UK domestic market will work and how economic operators with legal office in the UK should behave. It should be noted that, based on the Northern Ireland Protocol, the legislation applied in the Great Britain will not apply to Northern Ireland, that will have its own regulations.
As of 1 January 2021, all MDs, including in-vitro diagnostics (IVDs), marketed in Great Britain shall be registered at the MHRA. A transition period is provided for the registration, i.e.:
- class III and IIb implantable MDs, all active implantable MDs, and the product in the list IVD A shall be registered as of 1° May 2021;
- the remaining class IIb MDs and all class IIa MDs, and products in the list IVD B and self-diagnostic IVDs shall be registered as of 1 September 2021
- class I MDs, custom-made MDs and general IVDs shall be registered as of 1 January 2022.
Registrations can be performed only by subjects legally located in Great Britain.
The law regulating the MD marketing in Great Britain is still MDR 2002 (Medical Device Regulation 2002, as amended), still inspired to Directives 90/385/CEE, 93/42/CEE and 98/79/CE, although recently changed. It follows that the referred MD and IVD classification, for instance in terms of registration, is still that according to the directives and not according the MDR and IVDR.
A transition period for the market in Great Britain is provided for, and until 30 June 2023 all MDs with CE marking can be marketed in Great Britain; however, as early as 1 January 2021, all manufacturers with no legal office in UK shall appoint a UK responsible person, that will take on all responsibilities of the MDs in Great Britain.
The UK Responsible Person, who must necessarily have a legal office in the UK, will act on behalf of the manufacturer, and in compliance with the MDR 2002. This has a series of obligations such as, for instance, the DMs registration at the MHRA, ensuring that the manufacturer followed a suitable procedure to assess conformity, maintaining copy of all the relevant documentation, and cooperating with MHRA in case of requests aimed at demonstrating the MD conformity.
As already mentioned, it will be no more possible to market CE-marked products as of 30 June 2023; all MDs shall have the UKCA marking, only acknowledged in the UK. This marking shall be obtain for MDs requiring a certification via the assessment of their conformity by UK Notified Bodies, designated by MHRA, that will carry out their assessment in compliance with the MDR 2002. MDs complying with the UKCA marking shall bear it on the label together with the name and address of the UK Responsible Person where applicable.
Northern Ireland will not be subjected to MDR 2002, its inner market will be instead regulated by the EU legislation; this means that the MDR and the IVDR will become effective on the same date as in the EU. However, to be able to market MDs in the NI the designation of a UK responsible person will be still necessary for manufacturers not located in the UK, as the MHRA registration is still required; the only exception is for manufacturers of class I MDs, custom-made MDs, and “Other types of IVDs”, for which a registration at another European CA is sufficient, and that do not need a UK responsible person. Moreover, UKNI marking is provided; this marking, used in combination with the CE marking, allows the marketing in NI of MDs certified according to the European legislation but that also followed a certification process with a NB with legal office in UK. This marking is not recognised outside NI.
Finally, for MDs to be sold in the EU, the guideline confirms that these must have a CE marking to demonstrate their conformity and that the sole UKCA marking is not sufficient as it is not acknowledged by the EU. As early as 1 January 2021 it will not be possible to import in the EU market the following MDs:
- MDs whose certificates were issued by a NB with legal office in the UK;
- MDs reporting an authorised representative with legal office in GB;
- MDs from a manufacturer with legal office in GB without an authorised representative with legal office in the EU.
Written by: Daniele Scarpino