Post-Brexit: UKCA marking practicalities for medical devices
01 August 2021
MHRA provides medical device regulation guidance
Following Brexit, UKCA (UK Conformity Assessed) marking is the UK product marking requirement 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. This encompasses all medical devices, including those with electronic components or functionality.
This tutorial was originally featured in the August 2021 issue of EPDT magazine [read the digital issue]. And sign up to receive your own copy each month.
Here, Itoro Udofia, Director, Medical Health Service at global product testing & certification organisation, TÜV SÜD outlines the practicalities involved for medical devices…
UKCA marking was specified in the original ‘EU Exit’ UK Statutory Instruments, and indicates that a product placed on the market meets GB requirements. Initially, the UKCA marking requirements will align with the CE marking requirements that they replace, but over time, divergence is possible. It’s also important to take into consideration that additional requirements may be needed for products being placed on the UK Northern Ireland (NI) market, due to separate NI Protocol requirements.
For medical devices, the UK’s Medicines & 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) (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)
Although the UKCA mark may be required to place medical devices on the market in GB from 1 January 2021, CE marked devices are also permitted. However, as from 1 July 2023, it will be mandatory for every medical device to display the UKCA marking. So, manufacturers with CE marked products can continue to access the GB market until 1 July 2023, after which UKCA becomes mandatory.
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. This is intended to allow time for manufacturers to comply with the new registration process. 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 in order to be affix the UKCA mark and be placed on the GB market.
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; it is permitted for an importer or distributor to act as a UKRP. Their responsibilities include registering the medical devices with the MHRA before they can be placed on the UK market, and ensuring the manufacturer is compliant with the requirement 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.
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 (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 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.
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.
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