On 1 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) released a tranche of new Brexit guidance on the regulation of medicines, medical devices and in vitro diagnostic medical devices (IVDs) (together, Devices), from 1 January 2021 (Guidance). We explore the Devices section of the Guidance below.
It is worth noting that the Guidance will need to be given effect to by legislation, so the positions outlined below may change. References to Great Britain (GB) refer only to England, Scotland and Wales (not Northern Ireland (NI)).
While provisions have been made to seek a smooth transition from the current Devices regulatory regime (such as the continued recognition of CE marks for a period), there are indications (in the Guidance and elsewhere) that the MHRA intends to create a distinct Devices regime for the UK in the near future. The Guidance references to the new Medicines and Medical Devices Bill (the Bill), which provides broad regulation-making powers as regards Devices. The Guidance states that this presents the opportunity to develop a “robust, world-leading regulatory regime” and the chance to deliver “an attractive world-class regulatory system”. In our view, economic operators should be prepared for a regime which may look quite different in the medium term.
Dual paths to market after 1 January 2021
From 1 January 2021 to 30 June 2023 there will be two routes to the GB market for Devices: CE marks or UKCA marks.
Firstly, CE marked Devices (including under the existing Directives or the new EU Medical Device Regulation (2017/745) (MDR) and IVD Regulations (2017/746) (IVDR)) will continue to be able to be placed on the GB market. In theory, this means that a device CE marked under the Medical Device Directive 1993/42/EEC (MDD) could continue to be placed on the market in the UK after the date of application of the MDR (May 2021) for two years until 30 June 2023 even if it could not be placed on the market in the EU.
In addition, Devices will be able to be placed on the GB market if they bear the new UK Conformity Assessment (UKCA) mark. Assessments relevant to UKCA marks will be performed by a new UK entity, a Conformity Assessment Body (CAB) designated by the MHRA. All current UK Notified Bodies (noting there are only two currently) will automatically be designated as CABs. The UKCA mark will not be recognised in the EU.
From 1 July 2023, the dual paths to the GB market will end, and it will be mandatory for Devices to bear the UKCA mark before they can be placed on the GB market.
Registration and Responsible Person
All Devices placed on the GB market will need to be registered with the MHRA from 1 January 2021 subject to the following grace periods:
- four months for high risk Devices (class III medical devices, IVD List A etc.);
- eight months for moderate risk Devices (class IIa medical devices, IVD List B etc.); and
- twelve months for low risk Devices (class I medical devices, general IVDs etc.). This grace period does not apply in respect of Devices which are currently required to register with the MHRA.
In order to place a Device on the GB market, manufacturers based outside the UK will need to appoint a UK Responsible Person established in the UK. The registration for the relevant Devices will be the responsibility of the Responsible Person. The Responsible Person will need to be appointed in accordance with the registration timelines (i.e. the same grace periods will also apply to appointing a UK Responsible Person). In addition to registration, the UK Responsible Person is obliged to ensure that Devices conform with applicable requirements.
Under the terms of the Northern Ireland Protocol, the regulation of Devices placed on the NI market will differ to those in place for GB. From 1 July 2021, a CE mark will continue to be required to place Devices on the NI market, and EU rules, including those in the MDR and IVDR, will need to be met from when they apply in the EU. CABs will also be able to certify Devices for the NI market, with a UK(NI) mark, which will accompany CE marks. It is not entirely clear in the Guidance, but it appears that following 1 July 2023, Devices will need both a CE and UK(NI) mark to be placed on the NI market. Devices with both a CE mark and UK(NI) mark will not be capable of being placed on the EU market.
The registration requirements above will apply in respect of NI, meaning all Devices placed on the NI market will need to be registered with the MHRA in advance. Manufacturers based in NI will be able to register directly with the MHRA. Manufacturers based in GB will be required to appoint an EU authorised representative before placing Devices on the NI market. It appears that this entity must undertake the registration requirements with the MHRA. Conversely, EU based manufacturers will need to appoint a UK Responsible Person before placing a Device on the NI market. For manufacturers located in third countries (outside the UK and the EU/EEA) a UK Responsible Person or EU authorised representative will need to be appointed in respect of NI. In the case of the latter, the authorised representative must undertake the UK registration requirement.
In accordance with the Northern Ireland Protocol, the MHRA will continue to be the competent authority for surveillance and enforcement.
Manifestly, numerous issues may arise with the approaches described above. We can only hope that those issues will be addressed as they become apparent as we race to the end of 2020.
Key issues we foresee include the following. Firstly, it is unclear if and how the requirements for a new UKCA mark will depart from the requirements of the EU MDR and IVDR, particularly when the law in the UK is changed, in accordance with the Bill. In any case, the requirement for a new UKCA conformity mark necessitates some duplication of effort by Device manufacturers (and other economic operators), including in respect of labelling and appointment of locally established Responsible Persons. Further, it is possible that CAB capacity will be limited in the same way that new MDR/IVDR Notified Body capacity is limited, leading to delays.
Aside from those practical considerations, there are substantive regulatory matters not addressed in the Guidance, some of which were captured in the original Brexit amending statutory instrument for the UK Medical Device Regulations 2002 (UK MDR). These include:
- regulation of the devices set out in Annex XVI of the MDR (such as contact lenses) which are included in the scope of the MDR despite not having an intended medical purpose;
- obligations taken on by co-packagers of medical devices;
- obligations in regards to single-use medical devices and their reprocessing;
- in-house developed tests, in accordance with the IVDR; and
- requirements for labelling to include importer details (this may be particularly vexing for manufacturers in third countries, who could theoretically need importers designated and reflected on labels for both the UK/GB and EU markets).
The NI situation is also very complicated. Manufacturers will likely need to take particular steps for Devices for the NI market, including the obtaining of a CE and UK(NI) mark for these Devices (presumably both after 1 July 2023, although the Guidance is not clear on this). From when the MDR and IVDR apply, the potential for discrepancies in the NI and GB regimes increases. Registration and local establishment requirements will also need to be considered carefully. In view of the relatively small size of the NI market, this hopefully will not serve as a discouragement for manufacturers of Devices to supply to NI.
The following tables seek to summarise the requirements, terminology and new concepts:
Place on the Market (PotM)
|CE Marked under MDD/IVDD||CE Marked under MDR/IVDR||UKCA Marked under the UK MDR|
|UK (GB)||Can be PotM until June 2023.
Certificates issued by EEA-based Notified Bodies will continue to be valid for GB until 30 June 2023.
Up-classification of devices like software under MDR (May 2021) and IVDR (May 2022) is not relevant.
|Can be PotM until 30 June 2023.||Can be PotM indefinitely.|
|EU (+NI?)||Can be PotM until May 2021 (devices) or May 2022 (IVDs).
If eligible for transitional provisions, can be PotM until May 2024.
|Can be PotM indefinitely.||N/A.|
|UK Conformity Assessment Bodies||Notified Bodies||
Automatic designation for existing UK Notified Bodies with MDD, IVDD or AIMDD designations.
Certificates issued by EEA-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023.
New entities can apply to the MHRA for UK CAB designation from 1 Jan 2021. Can an EEA Notified Body (or equivalent) be designated as a UK CAB (whether for MDD or MDR)?
UK CABs will only be able to conduct UKCA conformity assessments for medical devices, AIMDs and IVDs under the UK MDR 2002 (as at 1 January 2021).
|UKCA Mark||CE Mark||The MHRA will recognise (automatically?) the CE Mark for devices until 30 June 2023. This will apply to products CE Marked under the MDD, IVDD, AIMDD, MDR and IVDR.
UK(NI) Mark: Where a Device has been assessed by a UK Approved Body, the UK(NI) mark will accompany, but not replace, the CE Mark. Devices carrying both the CE Mark and UK(NI) Mark cannot be placed on the market in the rest of the EU. UKCA marked devices will not be accepted in Northern Ireland unless accompanied by the CE or CE UK(NI) mark.
|UK Responsible Person||Authorised Representative||UK RP must be established in the UK and must be appointed for manufacturers based outside the UK who wish to PotM Devices.|
New Concepts: UK Registration (with the MHRA) for all Devices placed on the UK market
|Category||Expiry of grace period|
|Class III devices and Class IIb implantable devices, and all AIMDs||30 April 2021.|
|Other Class IIb and all Class IIa devices||31 August 2021.|
|Class I devices||31 December 2021.
No grace period for manufacturers of Class I devices and general IVDs that are already required to register with the MHRA.