An A-Z Guide to Medical Device Regulations in the United Kingdom
发表时间：2021-10-19 09:31作者：Clare Goodwin
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices. Since January 2021, there have been a number of changes when it comes to regulating medical products in the UK, and this article is intended to provide an easy-to-follow guide for ensuring your product meets the correct requirements.
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:
What legislation applies in Great Britain?
Currently, devices are regulated under the following Directives:
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:
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.
Certification Experts B.V. is an independent product compliance organisation. With over 25 years of experience, Certification Experts evolved into a hub of expertise and subsequently established a valuable track record. If you or your business require advice, certification or information surrounding the UK product market, please get in touch.