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December 2, 2024
Approximately 5 minutes
UK Medical Device Regulation: The Role of the MHRA, UKCA Marking, and Transitional Arrangements
UK Medical Device Regulation: Key Requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the medical devices market in the United Kingdom (UK). This guidance primarily focuses on the requirements for placing devices on the Great Britain (GB) market (England, Wales, and Scotland).
1. Legislation and Conformity Marking
The regulation is based on the Medical Devices Regulations 2002 (UK MDR 2002), which originally implemented legacy EU directives (EU MDD, EU AIMDD, EU IVDD).
The UKCA Marking
The UKCA (UK Conformity Assessed) marking is the new product marking for medical devices placed on the Great Britain market, replacing the CE marking for the long term.
- For devices requiring third-party conformity assessment, a UK Approved Body must be used.
- Manufacturers of non-sterile and non-measuring Class I devices and general IVDs can use self-certification for the UKCA mark.
Transitional Acceptance of the CE Marking
The UK government has introduced transitional measures to allow the continued acceptance of CE-marked medical devices on the GB market beyond June 30, 2023. The acceptance period depends on the device's classification and its compliance status:
| Device Type | Compliance Basis | Final Date for Placement on GB Market |
|---|---|---|
| General Medical Devices | EU MDD/AIMDD (with valid certificate) | Sooner of certificate expiry or June 30, 2028 |
| IVDs | EU IVDD (with valid certificate) | Sooner of certificate expiry or June 30, 2030 |
| All Devices (including custom-made) | EU MDR/IVDR compliant | June 30, 2030 |
2. Registration and UK Responsible Person
All medical devices, including IVDs and custom-made devices, must be registered with the MHRA before they are placed on the Great Britain market.
The UK Responsible Person (UKRP)
Manufacturers based outside the UK must appoint a single UK Responsible Person (UKRP) for all their devices. The UKRP acts on the manufacturer's behalf to carry out specified tasks, including:
- Registering the manufacturer's devices with the MHRA.
- Ensuring the Declaration of Conformity and technical documentation have been drawn up.
- Providing documentation to the MHRA upon request.
- Cooperating with the MHRA on any preventive or corrective actions.
The name and address of the UK Responsible Person must be included on the product labeling, outer packaging, or Instructions for Use when the UKCA marking is affixed.
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