Medical Electronics


What does UKCA marking mean for medical devices?


By Itoro Udofia, director, medical health service at TÜV SÜD, a global product testing and certification organisation


Medical devices must now be registered with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). However, there is a grace period according to the device type and its classification, which is intended to allow time for manufacturers to comply with the new registration process. 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


that a product placed on the market meets the requirements of Great Britain (GB) - England, Scotland, Wales, substituting the EU’s requirements for CE Marking. Although the UKCA mark may be required to place medical devices on the market in GB, CE marked devices are also permitted until 1 July 2023. As of 1 January 2021, new medical devices being placed on the market in the UK must follow the Medical Devices Regulations 2002 (UK MDR), which


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incorporates the requirements for: • Active implantable medical devices, Directive 90/385/EEC (AIMDD)


• General medical devices, Directive 93/42/EEC (MDD)


• In vitro diagnostic medical devices, Directive 98/79/EC (IVDD)


34 October 2021


devices that are sterile or have a measuring function, as they require approval from a UK Approved Body in order to affix the UKCA mark and be placed on the GB market.


Components in Electronics


If a UK body carries out a mandatory third- party conformity assessment, then a UKNI marking must be applied – but must be


KCA (UK Conformity Assessed) marking was specified in the original ‘European Union (EU) Exit’ UK Statutory Instruments. It indicates


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


UK responsible person


If the manufacturer is located outside the UK, they must appoint a UK responsible person (UKRP), who must be based in the UK and acts on behalf of the manufacturer to ensure that their obligations are carried out. It is permitted for an importer or distributor to act as a UKRP, and their responsibilities include registering the device with the MHRA, as well as ensuring the manufacturer is compliant and holds relevant documentation. It is important to note that the MHRA will only register devices where the manufacturer or their UKRP has a registered place of business in the UK. In all instances, where the UKCA mark has been affixed the name and address of the UKRP must be included on product labelling.


NI Protocol The Northern Ireland (NI) Protocol has created another layer of complexity for medical devices manufacturers as it means that NI aligns with relevant EU rules relating to placing manufactured goods on the market. This means that in NI, the CE mark is still required, 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.


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. The UK government guarantees NI businesses unfettered access to the UK market, without the need for additional approvals. Qualifying NI goods can therefore be placed on the GB market based on the conformity markings used in NI, such as the CE, and CE/UKNI markings. However, the UKCA mark cannot be used for goods placed on the NI market.


A new approach 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, where applicable, 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.


www.tuvsud.com/uk www.cieonline.co.uk


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