FEATURE u Medical Equipment & Devices


Medical device UKCA challenges


By Itoro Udofia, Director of Medical Health Service at TÜV SÜD, a global product testing and certification organisation.


I


UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that substitutes the European


Union’s (EU) requirements for CE Marking. It is now required for any product being placed on the market, including all medical devices, in England, Scotland and Wales. It is also important to take into consideration that additional requirements may need to be considered for products being placed on the UK Northern Ireland market due to separate NI Protocol requirements. 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) (UK MDR)). The UK MDR incorporates the requirements according to EU legislation 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) Any medical devices that were previously


registered with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) before 1 January 2021, do not require re-registration. To allow time for manufacturers to comply with the new registration process, there is a grace period according to the device type and its classification. While it is possible to register devices with the MHRA 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 (In Northern Ireland, these products must have been registered by 1 January 2021):


32 October 2021 Irish Manufacturing


• Class I medical devices • general IVDs


The 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. 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 the 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, in order to place products in the NI market. The UK government guarantees businesses in NI 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. Initially, the UKCA marking requirements will align with the CE marking requirements that they replace, but overtime divergence is possible. It’s also important to take into consideration that additional requirements may need to be considered for products being placed on the UK Northern Ireland market due to separate NI Protocol requirements. It is imperative that manufacturers register


products with the MHRA as soon as possible. To register with the MHRA, manufacturers must, where applicable, show evidence that their medical device has undergone conformity assessment by a UK Approved Body, which must be based in the UK. Following approval, the manufacturer will be able to affix the UKCA or UK(NI) mark. Alternatively, if a manufacturer’s products are CE marked, then they may also use their CE certificate as evidence to register with MHRA until 30 June 2023.


TÜV SÜD www.tuvsud.com/uk


www.irish-manufacturing.com


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