What changes have been enforced since 1 January 2021?
Due to Brexit, there were a number of changes made to legislation and requirements for those wishing to place products on the United Kingdom market. Inclusive of the secondary legislation, which has given product manufacturers in some industries extensions on the transition period/s, here are the key requirements to consider:
- The EU no longer recognises UK Notified Bodies
- UK Notified Bodies are not able to issue CE certificates
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- All medical devices placed on the Great Britain market need to be registered with the MHRA. There are several grace periods for some devices
- If you are a manufacturer based outside the UK, you will need to appoint a UK Responsible Person who will take responsibility for the product
What legislation applies in Great Britain?
Currently, devices are regulated under the following Directives:
- Active implantable devices – Directive 90/385/EEC (EU AIMDD)
- Medical devices – Directive 93/42/EEC (EU MDD)
- In vitro diagnostic medical devices – Directive 98/79/EC (EU IVDD)
The current legislation is still based on the requirements derived from current EU legislation.
What is the role of the MHRA?
The MHRA performs market surveillance of medical devices on the UK market and is able to take authority and make decisions on the marketing and supply of devices in the UK. They are the responsible body for the designation, auditing, and monitoring of UK Conformity Assessment Bodies.
The MHRA enforces these regulations via the Medical Devices Regulations 2002 (UK MDR 2002) and the General Product Safety Regulations 2005. These regulations are safety regulations under the Consumer Protection Act 1987 and as such give the MHRA the authority to investigate any business activity that is covered by these regulations in accordance with the Consumer Rights Act 2015.
What are the key requirements if I want to place my device on the UK market?
All medical devices, IVDs, and custom-made devices must be registered with the MHRA before they are placed on the market in Great Britain. The MHRA will only register devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK. If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a registered place of business in the UK.
In addition to these requirements, manufacturers may be required to affix the UKCA marking on their devices. The UKCA mark is a product marking used for certain goods being placed on the Great Britain market (England, Scotland and Wales). Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be a requirement to place a device on the Great Britain market.
Where third party conformity assessment is required, a UK Approved Body is needed. However, Class I devices and general IVD manufacturers can self-certify against the UKCA mark.
What is a UK Responsible Person?
A UK Responsible Person acts on behalf of any manufacturer who is not based in the United Kingdom and assumes the responsibility and legal obligations that a manufacturer based in the UK would undertake. In summary, the UK Responsible Person must adhere to the following:
- Ensuring that the declaration of conformity and technical files are completed and that any appropriate conformity assessment procedures have been carried out
- Keep all copies of the technical files, declaration of conformity, and certificates
- If approached by the MHRA, the Responsible Person must provide any necessary information or documentation to demonstrate the conformity of a device
- Comply with any request from the MHRA to provide samples or access to the device
- Immediately inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device
The name and address of the UK Responsible Person must be included on the product labelling where the UKCA mark has been affixed. This does not apply to labelling for CE marked devices.