How to Register Your Medical Device in UK
Registering a medical device with the Medicines and Healthcare products Regulatory Agency (MHRA) is a mandatory requirement before placing it on the UK market. The process ensures that only safe, effective, and compliant devices reach patients and healthcare providers. Below is a step-by-step guide to help manufacturers navigate the process.
1. Determine Your Device Classification
The first step is to correctly identify the risk classification of your device as per the UK Medical Device Regulations (UK MDR 2002). Devices can be categorized into:
- Class I (low risk)
- Class IIa and IIb (medium risk)
- Class III (high risk)
Classification impacts the level of regulatory scrutiny and the type of conformity assessment required.
2. Conformity Assessment
Once classification is established, a conformity assessment must be carried out to demonstrate compliance with the relevant safety and performance requirements. For higher-risk devices, this involves engagement with a UK Approved Body. The outcome of the assessment will determine whether the device is suitable for the UK market placement.
3. Technical Documentation and UKCA Marking
Manufacturers must compile comprehensive technical documentation covering the design, risk management, clinical evaluation, and performance testing of the device.
- Devices placed on the UK market require a UKCA mark.
- CE marking may still be recognized in Great Britain until specific transition deadlines, but manufacturers should plan for UKCA marking as the long-term requirement.
4. Appointing a UK Responsible Person (UKRP)
Non-UK manufacturers must appoint a UK Responsible Person (UKRP). The UKRP acts as the main contact with MHRA and assumes certain legal responsibilities, including:
- Registering the device with MHRA.
- Ensuring documentation and declarations of conformity are available.
- Cooperating with MHRA in case of safety or compliance concerns.
5. Device Registration with MHRA
Before the device can be marketed, it must be registered with the MHRA. Key steps include:
- Creating an MHRA account through the Device Online Registration System (DORS).
- Submit the required device information (classification, intended use, manufacturer details, UKRP details, and conformity assessment evidence).
- Paying the applicable registration fees.
Registration Fees: A statutory fee of £261 applies for each registration application. For more details on how fees are calculated, manufacturers should refer to the current MHRA fees schedule and the official fees consultation response.
Only once MHRA registration is complete, the device can be legally placed on the UK market.
6. Post-Market Surveillance and Vigilance
Regulatory responsibilities do not end after registration. Manufacturers and UKRPs must maintain post-market surveillance (PMS) systems to monitor device performance and ensure ongoing safety. Requirements include:
- Collecting and analyzing data from real-world use.
- Reporting adverse incidents and safety issues promptly to MHRA.
- Implementing corrective and preventive actions where necessary.
This ongoing vigilance is crucial for maintaining compliance and protecting patient safety.