Updated 16 November 2020
With the end of the transition period looming, and the UK/EU still in discussions in relation to a possible trade deal, the UK Government has published guidance in relation to the requirements for placing medical devices on the market in Great Britain (England, Scotland and Wales), Northern Ireland and the EU after 1 January 2021. The guidance, which has been updated a few times since it was first published, is in addition to a series of guidance published in relation to a range of issues concerning regulation of medicinal products and medical devices including clinical trials, licensing, importing and exporting, IT systems, pharmacovigilance and paediatrics. The guidance was also published at the same time as guidance in relation to products that are placed on the UK market generally, including in relation to marking requirements (discussed here).
The guidance given by the Government will be brought into effect via legislation to be adopted before the end of 2020, and so will be subject to parliamentary approval (see draft The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020).
As the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively (i.e., after the end of the transition period), they will not form part of 'retained EU law' in the UK. This means they will not apply automatically in Great Britain. The Medicines and Medical Devices Bill, currently going through Parliament, will provide for powers to create a 'world-leading' regulatory regime for medical devices, which will be the subject of public consultation.
From 1 January 2021, the MHRA will take on the responsibilities for the UK medical devices market currently undertaken through the EU system.
Requirements for those manufacturing and supplying devices in the UK
All medical devices and in vitro diagnostic medical devices (IVDs) to be placed on the GB market (England, Scotland, Wales) after 1 January 2021 will need to be registered with the MHRA, albeit with grace periods for registering as follows:
- 4 months (from 1 May 2021) ) for active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A products
- 8 months (from 1 September 2021) for Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B products and self-test IVDs
- 12 months (from 1 January 2022) for Class 1 devices and general IVDs (unless they are currently required to register with the MHRA - in which case, manufacturers should continue to register on the same basis as they do now until the new registration requirements start to apply to those devices; the grace period will not apply).
Registration will require a registered place of business in the UK. Manufacturers based outside of the UK that wish to place a product on the UK market will need to establish a UK Responsible Person who will take responsibility for the product in the UK.
Any medical device placed on the GB market from 1 January 2021 must have either a UKCA or CE mark, depending upon which legislation it has been certified under. In order to allow a streamlined transition, CE marking (including via self-certification) can continue to be used and recognised by the MHRA, and certificates issued by EEA-based Notified Bodies will continue to be valid, until 30 June 2023. However, a new route to market and product marking will be available for manufacturers wishing to place a device on the GB market from 1 January 2021, the UKCA (UK Conformity Assessed mark). We have discussed the new UKCA in more detail in our guidance here.
Manufacturers will able to choose to use the UKCA mark when placing a device on the GB market from 1 January 2021, and it must be used from 1 July 2023. Devices labelled with both CE and UKCA marks will continue to be accepted on the GB market after 1 July 2023.
Under the terms of the Northern Ireland protocol, there are different rules relating to medical devices being placed on the Northern Ireland market, which are discussed in more detail in a separate section in the MHRA guidance note. The MDR and IVDR will apply in Northern Ireland (from 26 May 2021 and 26 May 2022 respectively) and a CE mark will remain a requirement for devices placed on the Northern Ireland market. This means that, for example, from 1 July 2023, a CE mark must still be used on devices placed on the Northern Ireland market. The guidance also deals with when the UKNI marking will be required, in addition to the CE mark, for devices placed on the Northern Ireland market, and when such devices will need to be registered with the MHRA.
Placing a medical device on the EU market
From 1 January 2021, all medical devices for the EU market must adhere to the relevant EU legislation and be affixed with the CE mark to demonstrate compliance. The UKCA mark will not be recognised in the EU/EEA or Northern Ireland markets.
Where a UK-based Notified Body has been used to conduct mandatory third party conformity assessment in relation to devices placed on the market before 1 January 2021, these products may remain on the EU market. However, from 1 January 2021, a device cannot be placed on the EU market if the third party conformity assessment has been conducted by a UK Notified Body; an EEA-based Notified Body must be used.
Those manufacturers that currently CE mark on the basis of self-certification can continue to do so after 1 January 2021 for the EU market.
Regardless of when products were placed on the market, an EU/Northern Ireland based Authorised Representative will need to be appointed.