What is UK MDR 2002?
UK MDR 2002 is the short name for the Medical Devices Regulations 2002 (SI 2002/618). In Great Britain, that is England, Wales and Scotland, they set how a medical device reaches the market: classification, conformity assessment, marking, registration and post-market obligations. The Regulations originally implemented the EU medical device directives, and many requirements still refer to their annexes, for example classification under Annex IX of Directive 93/42/EEC. The regulator is the MHRA, acting for the Secretary of State.
In Northern Ireland, Regulation (EU) 2017/745 has applied since 26 May 2021, so a manufacturer selling across the United Kingdom may need to meet both regimes.
Who is it for?
The Regulations apply to anyone placing a medical device on the Great Britain market, wherever they are based. A manufacturer based outside the United Kingdom appoints a sole UK Responsible Person, established in the UK, who registers its devices with the MHRA (regulation 7A). Every device is registered with the MHRA through DORS before it is placed on the Great Britain market.
Key requirements
The Guardiso catalogue groups the requirements into seven requirement groups. The main ones are:
- Classification as Class I, IIa, IIb or III (regulation 7), conformity assessment and UKCA marking (regulations 10 and 13). MHRA guidance states that, among general medical devices, only non-sterile, non-measuring Class I devices can be self-certified; the others need a UK approved body.
- Registration with the MHRA before placing on the market, and a sole UK Responsible Person for a manufacturer outside the UK (regulation 7A).
- CE marked devices can be placed on the Great Britain market under regulation 19B (Directive 93/42/EEC) until 30 June 2028 and under regulation 19C (Regulation (EU) 2017/745) until 30 June 2030 (regulation 1ZA), with the technical documentation and declaration of conformity in English.
- Post-market surveillance under Part 4A, inserted by SI 2024/1368 for devices placed on the market after 16 June 2025: PMS system and plan, preventive and corrective actions, a PMS report for Class I or a PSUR, and retention of records for the longer of the PMS period and 10 years, or 15 years for implantable devices.
- Serious incident reports to the MHRA within 15 days, 10 days for a death or an unanticipated serious deterioration in health and 2 days for a serious public health threat, final reports, field safety corrective actions with field safety notices, and trend reports, submitted through the MHRA MORE portal.
- Enforcement: the MHRA can serve compliance, suspension, safety and information notices (sections 21 to 24 of the Medicines and Medical Devices Act 2021).
UK MDR 2002 and MDR (EU) 2017/745
Part 4A describes post-market surveillance and vigilance in a similar way to Articles 83 to 89 of Regulation (EU) 2017/745, including the same time limits for serious incident reports, so one surveillance process can serve both markets.
Market access works differently: MHRA registration instead of EUDAMED, a UK Responsible Person instead of an authorised representative, and UK approved bodies and UKCA marking instead of notified bodies and CE marking. The exception is CE marked devices accepted until the dates in regulation 1ZA.
The requirements for the device itself also differ. For general medical devices the UKCA route applies the essential requirements in Annex I of Directive 93/42/EEC (regulation 8) and the classification rules in Annex IX of that Directive (regulation 7). Active implantable medical devices and in vitro diagnostic medical devices have their own Parts of the Regulations. The EU applies the general safety and performance requirements in Annex I and the classification rules in Annex VIII of Regulation (EU) 2017/745.
How does Guardiso help?
Guardiso organises the requirements and the evidence. It does not register devices with the MHRA, submit reports to the MORE portal or grant UKCA marking; the manufacturer or its UK Responsible Person does that.
- When you enable the framework, the UK MDR 2002 requirements are added as controls with the regulation number, a status and an owner.
- Each requirement has an item in the evidence register describing the record to keep, for example a DORS registration confirmation, the PMS plan or an incident report.
- Cross-mapping to Articles 11, 29 and 83 to 89 of Regulation (EU) 2017/745 for companies selling in Great Britain and the EU.
- The framework page links to the incidents, policies, evidence and audits modules.
- The Medical Devices Regulations 2002 (SI 2002/618), consolidated text, legislation.gov.uk ↗
- SI 2024/1368, post-market surveillance requirements (Part 4A), legislation.gov.uk ↗
- MHRA: Regulating medical devices in the UK (gov.uk) ↗
- MHRA: Register medical devices to place on the market (gov.uk) ↗
- MHRA: Medical devices post-market surveillance requirements (gov.uk) ↗