Latest guidance on marking following the transition period
UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.
UKCA can be used to replace the CE Marking requirements at the end of the European Union exit transition period. This is referred to officially as the implementation period completion day (“IP Completion day”) which is scheduled to occur at 23:00 on 31st December 2020.
On 1 September 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance on how medical devices will be regulated in the UK after this transition period
The following timeline provides information on the key dates, including the requirements for registering products with the MHRA (please note that this is the current guidance, which may change as the political and trade negotiations continue):
Other points to note:
The two key immediate points of impact for you as a manufacturer are:
If your device is CE certified, you can continue place your product in the market in the UK until 30 June 2023, there will not be the need to re-label.
Please note that the requirements in Great Britain (England, Wales, Scotland) and Northern Ireland differ:
For over 30 years, TÜV SÜD has provided market access solutions and regulatory expertise for manufacturers and suppliers of medical devices and in vitro diagnostics. Our services put your product through its paces and ensure medical device market approval and acceptance.
With our TÜV SÜD Product Service GmbH Notified Body and TÜV SÜD Limited (UK) applying to become a UKCA Approved Body, our dedicated team of experts will be able to offer both CE marking and UKCA marking services following the transition.
The UK Approved Body designation process will open from 1 January 2021 under the UK Legislation MDR 2002, SI #618) and TÜV SÜD has already engaged in the process with the MHRA.
Please note, this information is based on current guidance. As the political and trade negotiations continue between the UK Government and the EU, there may be further changes to our current understanding. TÜV SÜD will continue to keep you informed on any changes and how it may affect you.