Steps and timing to transfer your UK Responsible Person
What Happened to the European Single Market?
February 10, 2022
Labeling Requirements for the EU, UK and Switzerland In-Country Representative
February 21, 2022Is it possible to transfer your UKRP?
Yes, it is possible to transfer your UKRP. There is nothing that prohibits transferring your UKRP from one company to another.
For more information about the role of the UKRP and how Casus can help, please read: UK Responsible Person Overview
Can I appoint more than one UKRP?
No, it is not possible to have more than one UKRP at the same time. Per the MHRA’s Guidance on Regulation Medical Devices in the UK, manufacturers can only have one UKRP and that UKRP must represent all of the manufacturer’s devices in Great Britain .
“If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.”
Therefore, this is an especially key role in the UK.
You designate an importer/distributor as your UKRP. That importer only sells certain devices in your product line, and you intend to sell different products to other distributors / hospitals / end users. That UKRP must still act as the UKRP for all those other devices. They must also register those devices, and your other importers, with the MHRA since they are the UKRP.
This is different from Europe, in which a manufacturer can have multiple EU Authorized Representatives, as long as they represent different devices.
Is a Transfer Agreement needed between UKRPs?
No, not at this time.
The reason this question is relevant is because the European MDR/IVDR (Art. 12) requires that:
“detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative.”
The UK left the European Union in the so-called ‘Brexit’ before the MDR/IVDR dates of application. As a result, the UK’s current legislation is still based on the old Directives , which were in force at the time they left the EU. The old Directives do not require a transfer agreement. That said, the MHRA is in the process of updating its legislation, with many MDR/IVDR level changes proposed. Therefore, it could be required in the future.
Steps to Transfer
The manufacturer must time the transition from its current UKRP to the new UKRP.
This is important because a UKRP is required to register the manufacturer they represent, and the manufacturer’s devices. However, the new UKRP cannot do this if there is already an active registration under a different UKRP. If so, the MHRA will reject the new UKRP’s application.
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- The original UKRP must log into their MHRA registration portal and deactivate the manufacturer’s registration. They should do so by selecting that they no longer represent the manufacturer as the UKRP. This process takes only a few minutes. The MHRA will then send an email notification of the change to both the UKRP and the manufacturer.
- The new UKRP will submit a registration application to the MHRA. As part of that, they must submit a ‘letter of designation’ verifying they are the UKRP. This must be “a legal contract, stating that you are the exclusive UK Responsible Person acting for the manufacturer…”
- The MHRA will review the new application. Barring any questions, registrations are generally approved within 6 business days, which is the MHRA’s quoted timeframe to complete registrations. Timeframes may be longer depending on staffing and volume of submissions.
Once the new registration is granted, the MHRA will issue a confirmation letter and publish the manufacturer and device registration on its public database.
The above is based upon the devices being CE marked. European CE marking is currently accepted by the MHRA due to a transition allowance. If the device is UKCA marked, then the following additional steps apply before starting the re-registration process:
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- If you have any Class I measuring/sterile, IIa, IIb, III/AIMD devices, inform your UK Approved Body of the change
- Update your documentation to reflect the new UKRP, e.g., Declaration of Conformity, technical documentation file, vigilance/post-market surveillance procedures
- Update labeling to reflect the new UKRP’s information
For more information on UKCA marking transition dates, please read: New Dates for UK Regulation & CE Marking
Labeling Updates
If you are placing devices onto Great Britain via the CE Marking transition period allowance, then no labeling updates are required. Per the MHRA guidance Regulating Medical Devices in the UK:
“The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.”
A few notes on the transition period:
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- The CE marking allowance is in place until June 2028 or June 2030, depending on the device. After the transition period ends, devices must have UKCA marking in order to continue to be placed onto the Great Britain market. For more information on the extact transition dates, please read: New Dates for UK Regulation & CE Marking
- Manufacturers may UKCA mark at any time, and do not have to wait for the above deadline. If you have opted to UKCA Mark early, then the UKRP information is mandatory on the labeling. In this situation, you must update your labeling to remove the old UKRP and add the new one.
Timing
It is ultimately based on:
1) the timeframe for the old UKRP to notify the MHRA that they no longer act as your UKRP
2) the timeframe for the new UKRP to submit the registration request
3) the timeframe for the MHRA to approve the application
If all parties move at a reasonable pace, it can be completed within two weeks.
