The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary:
- From 1 January 2021, different rules will apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed on the market in Northern Ireland and elsewhere in the EEA.
- Manufacturers may continue to use the CE-mark and it will be recognised in Great Britain until 30 June 2023.
- Manufactures may continue to rely on EEA Notified Body certificates until 30 June 2023 for products placed on the market in Great Britain.
- There will be a new route for conformity assessment of medical devices placed on the market in Great Britain from 1 January 2021.
- All medical devices and in vitro diagnostic medical devices (“IVDs”) placed on the market in the UK have to be registered with the MHRA. There will be certain grace periods for registering existing devices.
- Manufacturers based outside the UK will need to appoint a UK Responsible Person.
Future Regulation of Medical Devices and IVDs in the UK
In the EU, Regulation 2017/745 on medical devices (“MDR”) will enter into force on 26 May 2021 and Regulation 2017/746 on in vitro diagnostic medical devices (“IVDR”) on 26 May 2022. Since both Regulations will enter into force after the end of the Brexit transitional period, they will not be automatically transposed into UK domestic law through the EU Withdrawal Agreement Act. Thus, the UK Government intends to hold a formal consultation process with stakeholders in autumn 2020 with the aim of delivering an attractive world-class regulatory system. The Medicines and Medical Devices Bill, which seeks to increase oversight over medical devices and improve patient safety, is also currently pending before Parliament.
- Great Britain
The Guidance explains the different rules that will apply to medical devices placed on the market in Great Britain (i.e., England, Wales and Scotland) from 1 January 2021. We summarize certain of the key changes below.
a. Registration Requirements
Manufacturers who intend to place medical devices on the market in the UK have to register with the MHRA. Manufacturers based outside the UK will need to appoint a UK Responsible Person, established in the UK, to register on its behalf.
From 1 January 2021, any medical device, IVD or custom-made device must be registered with the MHRA before being placed on the UK market. There will be certain grace periods for manufacturers to complete the registration process. The length of the grace period depends on the category of device:
- Registration by 30 April 2021:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A
- Registration by 31 August 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B
- Self-test IVDs
- Registration by 31 December 2021:
- Class I medical devices
- General IVDs
The MHRA has published separate registration guidance to assist manufacturers with the process.
b. UK Conformity Assessment and UKCA Mark
Until 30 June 2023, manufacturers may rely on conformity certificates issued by EEA Notified Bodies for Class II and Class III devices. Moreover, until that date, the CE mark will be recognised on the Great Britain market. CE-marked devices that have been assessed by an EEA Notified Body will be deemed to meet the requirements of the new (UK conformity assessed) UKCA mark. From 1 July 2023, all devices placed on the Great Britain market, will have to bear the UKCA mark.
The UK intends to roll over the designation of any existing UK Notified Bodies, which are currently designated under the Medical Devices Directive 93/42/EEC, the in vitro Diagnostics Medical Devices Directive 98/79/EC and the Active Implantable Medical Devices Directive 90/385/EEC. From 1 January 2021, these bodies will be called “Approved Bodies”. These Approved Bodies will be able to carry out certain conformity assessments under the UK Medical Devices Regulations 2002, as amended.
For self-certification devices (Class I medical devices and general IVDs), the manufacturer will be able to complete the UK conformity assessment procedure and affix the UKCA mark to their devices. Manufacturers of these devices may also continue to rely on the EU CE-mark until 30 June 2023 for products placed on the Great Britain market.
From 1 January 2021, devices placed on the market in Great Britain will need to bear either the UKCA mark or the CE mark, as well as the number of the EEA Notified Body or UK Approved Body.
Products that bear the CE mark and the EEA Notified Body number do not have to be relabelled until 1 July 2023.
- Northern Ireland
Special rules will apply to devices placed on the market in Northern Ireland.
- Placing Devices on the EU Market
Any device placed on the EU market from 1 January 2021 must comply with the applicable EU legislation and the CE mark must be affixed to the device. The UKCA mark will not be recognised in the EU (including Northern Ireland), unless the device is also accompanied by the CE mark.
Manufacturers that are currently relying on a UK Notified Body need to bear in mind:
- Any devices placed on the EU market before 1 January 2021 in accordance with the EU-UK Withdrawal Agreement, may remain on the EU market.
- For any devices placed on the market after 1 January 2021, the manufacturer can no longer rely on the conformity assessment of a UK Notified Body. A conformity assessment by an EEA Notified Body will be required.
For self-certification devices, Great Britain-based manufacturers may continue to self-certify compliance with EU requirements. All Great Britain-based manufacturers intending to place CE-marked devices on the EU market will also need to appoint an Authorised Representative in the EEA.
Manufacturers based outside the EU may no longer rely on Great Britain-based Authorised Representatives for devices placed on the EU market. They will need to appoint an Authorised Representative in the EEA.