Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark.
UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that is now required for any product being placed on the market in Great Britain (GB) - England, Scotland, Wales, substituting the European Union’s (EU) requirements for CE marking. As from 1 July 2023, it will be mandatory for every medical device, to display the UKCA marking.
For medical devices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. As of 1 January 2021, medical devices being placed on the market in the UK must follow new legislation - the Medical Devices Regulations 2002 (SI 2002 No 618, as amended).
While all medical devices, in vitro diagnostic devices (IVD), and custom-made devices must be registered with the MHRA as from 1 January 2021, depending on the classification of a product there is a grace period according to the device type and its classification. While it is possible to register devices ahead of the dates below, there is no legal obligation to do so:
From 1 May 2021:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A products
From 1 September 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- self-test IVDs
From 1 January 2022 (Note: in Northern Ireland, these products must be registered by 1 January 2021):
- Class I medical devices
- general IVDs
Any medical devices that were previously registered with the MHRA before 1 January 2021, do not require re-registration.
Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark. It is important to note that the exception to the rule is Class I medical devices that are sterile or have a measuring function, as they require approval from a UK Approved Body.
If the manufacturer is located outside the UK, they must appoint a UK Responsible Person (UKRP), who must be based in the UK. The UKRP then acts on behalf of the outside-UK manufacturer to ensure that their obligations are carried out, and it is permitted for an importer or distributor to act as a UKRP. In all instances, where the UKCA mark has been affixed, the name and address of the UKRP must be included on product labelling.
Under the NI Protocol, the CE mark is still required in NI. So, even after 30 June 2023 CE marked medical devices can continue to be placed on the market. Under these rules, qualifying goods are those in free circulation in NI - not those under a customs procedure or in an authorised temporary storage facility before being moved between NI and GB.
If a UK body carries out a mandatory third-party conformity assessment, then a UKNI marking must be applied – but must be accompanied by EU conformity marking (e.g. CE marking). Goods with both the CE and UKNI marking cannot be placed on the rest of the EU market. If a mandatory third-party conformity assessment was carried out by an EU-recognised notified body, goods with the CE marking can be placed on NI and EU markets.
As a deviation from the GB requirements, the Medical Device Regulations, 2017/745(EU MDR) and the In Vitro Diagnostic Medical Device Regulations, 2017/746(EU IVDR) apply in NI from 26 May 2021 and 26 May 2022, respectively. This means that GB manufacturers will require an EU Authorised Representative, located either in NI or the EU, to place products in the NI market.
The changes being made to accommodate UKCA marking requirements necessitate a new approach and it is imperative to register products with the MHRA as soon as possible. To register with the MHRA you must show evidence that your medical device has undergone conformity assessment by a UK Approved Body, which must be based in the UK. Following approval from a UK Approved Body, the manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland). Alternatively, if your products are CE marked, then you may also use your CE certificate as evidence to register with MHRA until 30 June 2023.
