Approval of medical devices in the UK - A guide for manufacturers
Following Brexit, the United Kingdom has established an independent regulatory system for medical devices. While the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) were not automatically adopted, the UK Medical Devices Regulations 2002 (UK MDR 2002) continue to apply. In addition, the country is gradually introducing new requirements for UKCA labeling, which will become mandatory from July 2025.
This guide provides a comprehensive overview of the current regulatory requirements for the approval of medical devices in the UK.
General overview of the medical device market in the UK
Population size
The United Kingdom has a population of around 67 million people.
Market volume
- The UK market for medical devices is one of the largest in Europe and is estimated to be worth over 14 billion pounds (GBP).
- The UK imports a large proportion of its medical technology products, particularly from the EU.
Forecasts for the next three years
- The market for medical technology is expected to grow at a compound annual growth rate (CAGR) of 5 to 7 percent.
- Increasing investment in digital health technologies and the modernization of the National Health Service (NHS) are continuing to drive growth.
Competent authority for medical devices in the United Kingdom
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medical devices in the United Kingdom.
Tasks of the MHRA
- Implementation and enforcement of the UK MDR 2002
- Registration of medical devices
- Market surveillance and enforcement of vigilance requirements
- Designation and monitoring of UK Approved Bodies (UKABs)
- Regulation of UKCA labeling for medical devices
Official source of information
Further information can be found on the MHRA website.
Legal requirements in the United Kingdom
Overview of the UK MDR 2002
After Brexit, the existing UK Medical Devices Regulations 2002 (UK MDR 2002) were retained. These are based on the previous EU directives:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
The UK government is planning to gradually adapt these regulations in order to partially adopt the requirements of the MDR and IVDR.
Transitional arrangements for CE-marked products
Transition periods for CE-marked products have been set to avoid supply bottlenecks:
- MDD/AIMDD legacy devices: until June 30, 2028 or until the certificate expires
- IVDD legacy devices: until June 30, 2030 or until the certificate expires
- MDR/IVDR-certified products: until June 30, 2030
After these deadlines, products must either bear the UKCA mark or comply with new regulatory requirements.
UKCA labeling
The UK Conformity Assessed (UKCA) Mark replaces the CE marking for products placed on the market after July 1, 2025.
The procedure for obtaining the UKCA marking is similar to that for CE certification, but with some country-specific differences.
Information on the need for a local representative
Is a local representative required to approve or register medical devices?
Yes, manufacturers outside the UK must appoint a UK Responsible Person (UKRP).
Tasks of the UK Responsible Person (UKRP)
- Registration of medical devices with the MHRA
- Checking the technical documentation for conformity with UK regulations
- Support with vigilance and reporting obligations
A manufacturer can only name one UKRP at any given time.
Definition and classification of medical devices
Under what law is this determined in the UK?
Medical devices are classified in accordance with the UK Medical Devices Regulations 2002 (UK MDR 2002).
Classification of medical devices according to UK MDR
The United Kingdom follows the former EU directives, so that medical devices are divided into the following classes:
- Class I - Low risk
- Class IIa - Medium risk
- Class IIb - Higher risk
- Class III - High risk
Special categories:
- Active implantable medical devices (AIMD)
- In-vitro diagnostics (IVD)
Approval procedure for medical devices in the United Kingdom
What approval procedures are there?
All medical devices must be registered with the MHRA before being placed on the market.
Documents required for registration
- Designation letter in which the UKRP is named
- Table of contents of the technical documentation
- Declaration of conformity
- UKCA certificates for products in risk class II and higher
Average duration of approval procedures
- The processing time for a registration is usually a few days, provided that all documents are complete.
Costs incurred
- The registration costs vary depending on the product class.
Validity of the registration or approval
- The UKCA label remains valid as long as the underlying certificates do not expire.
Language requirement
- All submissions must be in English.
Conclusion
The approval of medical devices in the UK requires early preparation, as the regulations after Brexit differ from EU regulations.
Important points summarized:
- Medical devices must be either CE or UKCA marked
- Transition periods for CE products apply until 2028 or 2030
- UK Responsible Person (UKRP) required for non-GB manufacturers
- All documentation and submissions must be in English
Support from MEDAGENT
MEDAGENT offers comprehensive services for market access in the United Kingdom:
- Assumption of the UK Responsible Person (UKRP) function
- Support with UKCA labeling and registration
- Advice on quality management in accordance with ISO 13485
- Direct communication with the MHRA to optimize the approval process
