Exit of the United Kingdom from the European Union has implications on the medical device and IVD industry. The post-Brexit medical device regulations released by the UK MHRA mandated that all the foreign medical devices and IVD companies to appoint a United Kingdom Responsible Person (UKRP) to act on their behalf.
As a result of the UK MHRA mandate, starting from January 01, 2021, the manufacturers have already been appointing the UK Responsible Person as per the four (04) months, eight (08) months and 12 months’ transition timelines for various device categories. Though appointing a UK Responsible Person sounds like a one-time activity, there are various aspects to be taken care from time to time post the appointment.
If your device is UKCA (UK Conformity Assessed) labeled product, you need to add the details of your UK representative (UKRP), immediately after appointing one. In case your device is CE marked and is entitled to marketing till 2023 timeline, the UKRP details need not be added to the device labels till then. The UKRP details, however, should be included after these timelines.
The manufacturer should periodically review the ongoing communications between the UK MHRA, United Kingdom Representative (UKRP) entity and the manufacturer. The manufacturer must ensure that the ongoing communications are compliant and that the UKRP is transferring the information on a timely basis. Some UKRP entities submit quarterly or bi-annual reports to their manufacturers.
There are periodic renewals that the manufacturer must ensure for continued compliance. The expiration dates for service agreement made between the UKRP and the manufacturer must be actively monitored and the renewal process must be initiated well in advance to ensure its renewal before the expiration date. Many manufacturers prefer to appoint an UKRP on annual basis for the first year and depending on the reliability and service satisfaction, the agreements are renewed for multiple years thereafter.
The UK MHRA device registration expiration dates shall be tracked and renewed. The approvals are usually required to be renewed on annual basis for the first time and subsequently for every two (02) years. The manufacturer shall co-ordinate with the UKRP and ensure that the Periodic Safety Update Reports (PSURs) are submitted to the UK MHRA at a frequency defined in the regulations for a given device class.
The UKRP ensures continued compliance to the new amendments made to the MHRA’s Medical Device Regulations. The regulations have been previously amended in 2019 and 2020. Currently, more amendments are being introduced in these regulations to match up with the key requirements defined in the EU Medical Device Regulations. The new amendments are expected to be finalized and released in the later months of 2021.
With the above scenarios comprehensively discussed, it is clear that every non-UK medical device manufacturer willing to access the UK market must understand the importance of appointing a UKRP and they should be aware of various considerable aspects after appointing a UKRP. Gain more insights on UKRP? Reach out to a regional Regulatory expert. Stay informed. Stay compliant.