UKRP April 2023
Understanding the Role of UKRP in UK Medical Device Regulations
In the world of medical devices, compliance with regulations is paramount to ensure the safety and efficacy of products. For medical device manufacturers looking to enter the United Kingdom (UK) market, understanding the concept of a UKRP or United Kingdom Responsible Person is crucial. In this blog, we will explore the legal basis, responsibilities, and other pertinent information related to UKRPs in the context of UK medical device regulations.
What is a UKRP?
UKRP stands for United Kingdom Responsible Person. It is a mandatory appointment required for medical device manufacturers located outside the UK and lacking local business offices. The UKRP acts on behalf of the foreign manufacturer and takes on specific responsibilities, ensuring the device's compliance with UK regulations. This appointment is a prerequisite for registering and launching medical devices in the UK market.
Legal Basis for a UKRP
The legal framework for UKRPs is established in the UK MDR 2002 (Medical Device Regulations 2002). This regulation sets out the pre-requisites to appoint a UKRP and defines their responsibilities, along with other related information.
When to Appoint a UKRP?
For medical device manufacturers with devices already marketed in the UK, appointing a UK Responsible Person was required by January 1st, 2021. On the other hand, manufacturers intending to place their devices in the UK market must appoint a UKRP before initiating the device registration process with the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Responsibilities of a UKRP
The UK Responsible Person holds significant responsibilities to ensure compliance and facilitate smooth market access for medical devices. Their responsibilities include:
Device Registration: The UKRP acts on behalf of the foreign manufacturer to register the medical devices with the MHRA before they are placed in the UK market.
Document Compliance: Ensuring all necessary device technical documentation and applicable declaration of conformity documents are in place, and that the conformity assessment has been completed by the device manufacturer.
Document Maintenance: Keeping copies of original and updated technical documentation, declarations of conformity, and certificates. These documents must be readily available for inspection by the MHRA.
Conformity Assurance: Being able to present documents that demonstrate the device's conformity with relevant regulations.
Incident Reporting: Promptly informing the foreign manufacturer about any suspected incidents, complaints, or reports received from healthcare professionals, patients, and users. The UKRP must also cooperate with the MHRA for any corrective or preventive actions taken to mitigate identified risks.
Sample Access: Either maintaining samples of the device or having access to them for providing them to the MHRA upon request. If unable to do so, the UKRP must forward the MHRA's request for samples or access to the manufacturer.
Non-Conformities: In the case of non-conformities with applicable regulations, the UKRP shall terminate the agreement with the device manufacturer and inform the MHRA and relevant Notified Body, if applicable.
Who can Act as a UKRP?
Any third-party entity, importer, or distributor can act as a UK Responsible Person on behalf of the foreign manufacturer. The appointed UKRP must register with the MHRA to assume their responsibilities.
Labeling Requirements for UKRPs
Starting from January 1st, 2021, it is mandatory to include the name and address of the United Kingdom Representative on the label of a medical device bearing the UKCA mark.
In conclusion, understanding the role of a UKRP is crucial for medical device manufacturers seeking entry into the UK market. Compliance with UK medical device regulations through the appointment of a UK Responsible Person ensures adherence to safety standards and facilitates a successful market launch in the UK. As the landscape of regulations evolves, manufacturers must stay informed and partner with reliable UKRPs to navigate the complexities of the UK medical device market.