Medical Device Regulation 2002

Medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the Directive 90/385/EEC on active implantable medical devices (EU AIMDD), Directive 93/42/EEC on medical devices (EU MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).

Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in GB. Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland.

The responsible agency for regulating the UK medical devices market is the Medicines and Healthcare products Regulatory Agency (MHRA).

Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:

• a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the GB market;
• all medical devices, custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the GB market;
• if you are a medical device manufacturer based outside the UK and wish to place a device on the GB market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration;
• 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 GB market until 30 June 2023;
• the EU no longer recognises UK Notified Bodies;
• UK Notified Bodies are not able to issue CE certificates – and have become UK Approved Bodies;

Manufacturers of Class I medical devices and general IVDs can self-declare the conformity of their devices against the UK MDR. However, manufacturers of Class I medical devices that are sterile or have a measuring function must use a UK Approved Body to undertake third party conformity assessment in order to affix the UKCA mark. For higher classes (i.e. Class IIa, IIb and III) an Approved Body involvement is necessary. Currently there are only four UK Approved Bodies for medical devices – BSI, DEKRA, SGS and UL.

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