How does the recent EU-proposed amendment to the MDR affect products sold in the UK?
Over the past few months, we have provided updates regarding the proposed amendments to MDR Regulations (EU) 2017/745 and (EU) 2017/746 by the European Commission, which is now in effect.
However, how does this amendment affect products going to the UK?
A guidance document containing frequently asked questions regarding the amendment has been released. This amendment extends the MDR transitional period and eliminates the “sell-off” period for both medical devices and IVDs.
Unfortunately, the expected Questions and Answers (Q&A) on the practical implementation of the extension of the Medical Devices Regulation (MDR) transitional period have not been published yet.
Regarding the UK market.
Existing medical device stock (Trade name, Model/Version, Catalogue/Reference) already placed on the UK market (including stock in UK warehouses) prior to the expiry of the CE/UKCA certificate can remain on the UK market.
The EU extensions apply automatically in Northern Ireland. Certificates that have been extended will also be recognised as valid for placing CE-marked devices on the GB market. But you should note that if the CE certificate is extended beyond the date at which UKCA marking is mandatory then the products must be UKCA compliant.
However, you cannot register or place devices (including new stock) with expired CE or UKCA certificates on the UK market. Any existing registrations where the CE/UKCA certificate has expired will have a status of ‘Conformity Assessment Certificate expired’ until updated or new certificate details have been provided.
This status will also be appended to the GMDN Term on the Public Access Registration Database (PARD). You will also be unable to order Certificates of Free Sale for the affected products until a new CE or UKCA certificate is uploaded in the device registration system.
If you need to place medical devices that do not have the required CE or UKCA certificate on the UK market, you can contact the NHRA Exceptional Use team at Devices.ExceptionalUse@mhra.gov.uk for information on the process to obtain an exemption from the UK Medical Devices Regulations.