Medical Devices Regulation And Brexit
As we begin life outside of the EU, we summarise in this brief article the proposed approach that manufacturers and suppliers of medical devices need to do adopt in order to place a medical device on the United Kingdom (‘UK’) and European Union (‘EU’) markets from 1 January 2021.
The draft legislation (still to receive UK parliamentary approval) introduces, amongst a range of requirements, a new UK Conformity Assessed Mark (‘UKCA’) and business registration requirements for devices manufactured and supplied in England, Wales and Scotland (‘GB’) as well as the need to maintain existing European equivalents for devices supplied to the EU and Northern Ireland (‘NI’) markets.
Our summary is based on guidance published by the UK Government on 31 December 2020 and new draft legislation that is still subject to UK parliamentary approval.
New UK Legislation:
New draft UK legislation, governing the placing of medical devices on the UK market, is currently awaiting UK parliamentary approval. The proposed legislative approach is intended to apply to the UK instead of the delayed EU Medical Devices Regulation (‘MDR’) and In Vitro Diagnostic Medical Devices Regulation (‘IVDR’) (which will now apply in the EU from 26 May 2021 and 26 May 2022 respectively).
The new draft legislation outlines different requirements that will apply to medical devices placed on the market in GB compared to those placed on the market in NI (a consequence of the Northern Ireland Protocol).
Until this legislation is passed, the Medical Devices Regulations 2002 (derived from current EU legislation) continue to have effect in GB.
The UK’s Regulator:
The Medicines and Healthcare products Regulatory Agency (‘MHRA’) has now taken over responsibility for the UK medical devices market from the EU system, becoming the UK’s standalone regulator for medicines and medical devices.
Manufacturing And Supplying Medical Devices In GB:
From 1 January 2021, there are changes to how medical devices are placed on the GB market. Key points for stakeholders to be aware of include:
- all medical devices and in vitro diagnostic devices placed on the GB market after 1 January 2021 need to be registered with the MHRA – there will be a grace period for registering certain classed devices.
- The UKCA, issued by UK Approved Bodies, is available for manufacturers from 1 January 2021 – the UKCA will become mandatory after 1 July 2023.
- Any medical device must have either a UKCA or CE mark – CE marking (including self-certification) and certificates issued by EU-recognised Notified Bodies will continue to be valid until 30 June 2023.
- UK Notified Bodies are no longer able to issue CE certificates (other than for the purposes of CE UKNI marking, valid in NI) and have become UK Approved Bodies.
- Registration with the MHRA requires a registered place of business in the UK – manufacturers based outside of the UK that wish to place a product on the GB market will need to appoint a single UK Responsible Person who takes responsibility for the product in GB.
Manufacturing And Supplying Medical Devices In NI:
Under the Northern Ireland Protocol, from 1 January 2021, the rules for placing medical devices on the NI market differ from those applicable to GB. Key points for stakeholders to be aware of include:
- The MDR and IVDR will apply in NI (from 26 May 2021 and 26 May 2022 respectively).
- CE marking remains a requirement for medical devices placed on the NI market.
- GB based manufacturers need to appoint an EU or NI based Authorised Representative to place devices on the NI market.
- Certain medical devices, including in vitro diagnostic devices, placed on the NI market need to be registered with the MHRA. Registration timings for certain classes of device are subject to grace periods – Class I devices, custom-made devices and general in vitro diagnostic devices are required to be registered from 1 January 2021.
Manufacturing and supplying medical devices in the EU: From 1 January 2021, all medical devices placed on the EU market must adhere to the applicable EU legislation and be affixed with the CE mark to demonstrate compliance. Key points for stakeholders to be aware of include:
- UKCA marks are not recognised in the EU or NI markets.
- Where a UK-based Notified Body has been used to conduct mandatory third-party conformity assessments prior to 1 January 2021, those devices may remain on the EU market – this will cease to apply to new assessments conducted by a UK Notified body after 1 January 2021.
- Regardless of when products were placed on the market, an EU or NI based Authorised Representative must be appointed.
- Manufacturers that currently CE mark on the basis of self- certification can continue to do so after 1 January 2021 for the EU market.
While manufactures of medical devices will need to get up to speed quickly on the new regulatory landscape in GB, NI and EU, the end of the Brexit transition period, and conclusion of ‘The EU-UK Trade and Cooperation Agreement’, has provided welcomed clarity to the sector. Geldards will continue to monitor developments and share details as they become available.
Should you have any questions, please contact a member of our Commercial Team.