Latest guidance on marking following the transition period
On 31 December 2020, the transition period following the United Kingdom’s (UK) exit from the European Union (EU) came to an end. A new regulatory scheme, UKCA (UK Conformity Assessed) will be applied to products being placed on the market in the UK.
For medical devices, 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 from 1 January 2021.
The legislation that applies in the UK is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). The UK MDR incorporates the requirements according to EU legislation on:
CE marked devices can still be placed on the market in the UK until 30 June 2023. However, manufacturers must:
For continued and uninterrupted service to our customers, TÜV SÜD is in the application process with the MHRA to be designated as a UK Approved Body for medical devices. TÜV SÜD BABT is already a UK Approved Body for the following regulations below:
The following timeline provides information on the key dates, including the requirements for registering products with the MHRA:
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 diagnostic devices. Our services put your product through its paces and ensure medical device market approval and acceptance.
TÜV SÜD (UK) is in the application process to become a UK Approved Body and once designated, together with our TÜV SÜD Product Service GmbH Notified Body, our dedicated team of experts will be able to offer both CE marking and UKCA marking services.
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