Estimated Timeline: 2 Weeks, if the device is already CE Marked or UKCA Marked. If the device is not CE or UKCA Marked, the process may take an additional 2-4 months (lowest risk device) to 1-2 years (mid-to-high risk device).
1. Obtain product approval
Complete EU CE Marking or UK Conformity Assessment (UKCA Marking).
Manufacturers can leverage their European CE Marking to place devices throughout the UK until 2028-2030, depending on the type of device.
IMPORTANT: the requirements will be different between Great Britain
and Northern Ireland. For Great Britain, medical device manufacturers must obtain UKCA Marking by 2028-2030 (depending on the type of device), in order to continue placing devices onto the market. Northern Ireland, however, will continue to require CE Marking after this time.
UKCA Marking is separate from, but similar to CE Marking requirements. The lowest risk devices will be self-certified by the manufacturer. Meanwhile, higher risk devices will require a UKCA Marking certificate issued by a UK Approved Body.
A UK Responsible Person (UKRP) is required for non-UK based manufacturers.
The MHRA granted transition deadlines over the course of 2021 for manufacturers to appoint a UKRP. However, the transition period is now over. As of 1 January 2022, a UKRP is mandatory to place medical devices onto the market.
The UKRP’s role is currently similar to the role of the EU Authorized Representative (AR) under the old European Directives.
However, the MHRA has proposed changes to the role within their public consultation published in September 2021. These changes increase the responsibilities and liability of the UKRP, making the role more similar to the EU AR under the new European Medical Device & IVD Regulations.
Your UKRP registers your company and devices with the Medicines and Healthcare products Regulatory Agency (MHRA). UK-based manufacturers will create an account with the MHRA and register themselves.
Basic information about the device and manufacturer are submitted as part of the registration process, along with the manufacturer’s declaration of conformity (for self-certified products) or conformity assessment certificate.
As part of the registration process, the UKRP must provide documentation proving that you have granted authority for the company to act as the UKRP, such as a Letter of Designation or copy of the UKRP Agreement.
The MHRA quotes up to 5 days to process the application. The information in the application and timing are generally the same for all risk classes of devices.
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