UK Responsible Person for Medical Devices & IVDs
Following the UK’s departure from the EU, manufacturers of medical devices (MDs) and in vitro diagnostic devices (IVDs) must appoint a UK-based Responsible Person to comply with the revised UK regulatory framework. Mutual recognition with the EU no longer applies, making this step essential for lawful market access in Great Britain and Northern Ireland.
Manufacturers seeking to place devices on the EU market can no longer rely on a UK-based Authorised Representative. A new EU Authorised Representative must be appointed, and all necessary product registrations completed according to EU requirements.
Grace periods for product registration vary depending on device classification. To help manufacturers navigate these changes, we have developed two concise videos explaining the new UK and Northern Ireland medical device requirements and compliance obligations.
REGULATING MEDICAL DEVICES (UK)
- You can read more information on the UK Gov web site here about what is actually required.
- However to summarise:
A new role – the UK Responsible Person – has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market
You can read more about the UK Responsible Person’s obligations in regulation 77 (for medical devices) and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
UK RESPONSIBLE PERSON RESPONSIBILITIES
The UK Responsible Person roles are generally similar and include:
DOCUMENTATION CHECK
- Verify the Declaration of Conformity
- Review the Technical Documentation
- Check where applicable that an appropriate conformity assessment exist
- Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years and for implantable devices, it’s 15 years)
- Record Retention and Document control including version controls.
- Ensure Labelling is correct and includes the details of the Authorized Representative.
REGISTRATION CHECK
- Verify that the manufacturer is complying with the registration of the Unique Device Identification according to article 27
- Make sure that the registration of the device is performed according to article 29, Register on MHRA database for UK.
- Also that the registration of the manufacturer, Authorized Representative and importers are done according to article 31
AUDIT SUPPORT
- In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
- Keep the manufacturer informed of any request coming from the competent authorities.
- Verify that the competent authorities receive the samples or is given access to the device.
- Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices
VIGILANCE REPORT / MONITORING
- Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device.
- This can be something important to precisely write on the agreement. Check the last chapter on KPIs
COMPLIANCE
- Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation
- (Note: the requirements for In-vitro Devices are slightly different.)
CHANGING YOUR AUTHORISED REPRESENTATIVE
- Changing your Authorized Representative is a fairly straightforward process. The Medical Device Regulations 2000 gives full details of how this can be done.
- First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights.
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.