Since 01st January 2021, all non-UK medical device manufacturers (including IVDs) have been required to appoint a UK Responsible Person (UKRP) to act on their behalf in carrying out specific tasks, in order to place their devices on the Great Britain market.
In summary, the UKRP’s responsibilities include the following as a minimum:
- Device registration
- Technical documentation review
- MHRA engagement
- Vigilance and complaint support
We are just over 7 months into the requirement and now that 01st May 2021 has come and gone, all Annex II List A IVDs should be registered with the MHRA. Annex II List B and Self-test IVDs have until 01st September 2021 to be registered and General IVDs have until 01st January 2022.
So, what lessons have we learnt so far for IVDs?
Letter of Designation
Non-UK manufacturers must prepare a Letter of Designation (LoD) to appoint their UKRP. This needs to be signed by both parties and is provided to the MHRA as part of device registration.
The device registration process will be a lot smoother if non-UK manufacturers and their designated UKRP ensure the LoD takes into account the following:
1) Manufacturer’s details, especially the name and address, are consistent within the LoD, Declaration of Conformity (DoC), EC certificates (where applicable) and the device registration application;
2) Include an expiry date for the LoD;
3) Attach a list of all IVDs (device name and code) to be registered to the LoD;
4) Specify the UKRP responsibilities as mentioned in the MHRA guidance (https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk).
Device Names and Codes
When compiling a list of IVDs to be registered, I urge manufacturers to check that device names and any reference codes are consistent with, i.e. appears the same as, other documents such as labels, DoC and EC certificates. The UKRP will use this list to register the devices and getting it right first time will reduce the risk of application rejection.
Manufacturers also need to consider and communicate with their UKRP what device information they want printed on an MHRA Certificate of Free Sales (CFS). Do you just want the device name to be printed, or do you have different models and reference codes that also need to appear on a CFS?
Global Medical Device Nomenclature (GMDN) codes are used to name and group medical devices and are required as part of MHRA device registration. Manufacturers need to register for an account on the GMDN website (https://www.gmdnagency.org/) to obtain GMDN codes.
Manufacturers should aim to obtain GMDN codes, for every IVD to be registered, early in the process. Include them in the list of devices to be registered that is provided to the UKRP. Without them, submission of the registration application can be delayed.
As an aside, where manufacturers have more than one device with the same GMDN codes, the UKRP can register the devices using a bulk upload. This saves a lot of time and will speed up the UKRP’s preparation time for the device registration application.
Finally, manufacturers need to find the right people with the experience to help walk through the process. Device registration is just the beginning, and this includes technical documentation reviews by the UKRP. Finding and appointing a UKRP that is the right fit for a non-UK manufacturer will pave the way for a smoother ride further down the line. This is critically important as we get closer to understanding the new requirements of the UKCA process, where the UKRP will play a key role to providing information back to the manufacturer.
Key points for non-UK IVD manufacturers to consider for appointing their UKRP and MHRA device registration: