In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is considering the possibility to postpone the requirement for affixing of the UKCA marking under certain unavoidable conditions.
The scenario proposed as a result of the aforementioned assessment would amend of what has already been published within the Regulating Medical Devices in the UK guideline updated last January, which set June 30, 2023 as the final and mandatory deadline for affixing the UKCA mark.
As reflected in the document Government response to consultation on the future regulation of Medical Devices in the United Kingdom updated last June 26, MHRA in fact expresses the possibility of allowing devices already CE-marked to remain on the UK market after June 30, 2023. Such an extension would depend on the expiration of the certificate or a defined term, namely 3 years (for Medical Devices) and 5 years (for IVDs).
In detail, the extension would be as follows:
- CE marked devices benefitting from a Period of Grace in accordance with MDD, AIMDD and IVDD: can be placed on the market for 3-5 years from 01/07/2023;
- CE marked devices in accordance with MDR and IVDR: can be placed on the market for 3-5 years or until the expiration of the EU certificate, whichever is earlier.
However, it would be possible to take advantage of this extension upon the occurrence of certain conditions during the transitional period, in particular:
- the absence of significant changes involving the design or intended use of the device;
- full compliance with the post-market surveillance requirements defined by UK regulations;
- that certificate and declaration of conformity have been issued prior to 30/06/2023;
- that the devices were placed on the market in the territory before 30/06/2023 in compliance with UK legislative and regulatory requirements, particularly with regard to registration with MHRA.
No problem of free circulation in the UK territory, on the other hand, for devices already with UKCA marking as of July 1, 2023.
If ratified, this choice would be of clear benefit to all non-UK manufacturers of Medical Devices and IVDs, ensuring them a useful extension of time to obtain a UKCA certificate from designated Notified Bodies who today are still insufficient in number to be able to cope with market and health needs.
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Source: Government response to consultation on the future regulation of Medical Devices in the United Kingdom