12 Jun 23
UKCA marking, or UK Conformity Assessed (UKCA) is the medical device manufacturer’s mark demonstrating that a product meets the Essential Requirements (ER) of the United Kingdom Medical Device Regulation 2002 (as amended) known as UK MDR 2002.
UKCA marking came into force for medical devices in January 2021 when the United Kingdom (UK) left the European Union.
There have since been a number of changes introduced through secondary legislation which affect how medical devices, including IVD’s are placed on the UK market.
The UK government plans to review the current legislation with a plan to introduce the new legalisation by July 2025 including transitional arrangements.
Based on UK governments acceptance of (EU) 2023/607 (the regulation extending the duration of CE marking certificates for legacy devices under Regulation 2017/745) *certified medical devices that meet the criteria of MDR Article 120 and (EU) 2023/607 may be placed on the UK market until:
• 31 December 2027 for Class III and certain Class IIb implantable devices
• 31 December 2028 for other Class IIb, Class II, Class Is, Class Ir, Class Im devices.
After these timelines only UKCA marking will be accepted.
It is important to note that the Northern Ireland (NI) protocol is still under discussion and therefore it is likely that any new legalisation may differ for NI.
*https://www.gov.uk/government/news/extension-of-ce-certificates
The following devices are currently covered by the UK MDR 2002 (as amended) and are expected to be covered by the new legislation:
• Medical Devices
• Active Implantable Medical Devices
• In-Vitro Diagnostic Medical Devices
Generally, those manufacturers that self-declare under MDD 93/42/EEC and MDR 2017/745 will be able to continue to self-declare under UK MDR 2002, but please check the latest MHRA updates as it is the manufacturers responsibility to ensure they comply with all relevant legislation.
To place a medical device on the UK market (England, Scotland, Wales) manufacturers based outside of the UK must appoint a UK RP.
According to the current version of the UK medical device legislation (UK MDR 2002 as amended) a manufacturer shall designate only one UK RP.
The UK RP has specific responsibilities and must provide written evidence that they have the manufacturers authority to act as their UK RP.
The UK RP is defined as “a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom” and that “has specified tasks with regard to the manufacturer’s obligations” under the regulation.
Below is a *short summary of the UK RP responsibilities:
• Register with the **MHRA
• Ensure that copies of the relevant manufacturer’s documentation are available including the UK declaration of conformity.
• Where applicable ensure that the manufacturer has completed the appropriate conformity assessment
• Respond to MHRA
• Co-operate with the MHRA
• Provide samples of the relevant device/s on request
• Ensure any complaints and/or reports are passed to the relevant persons
*Not an exhaustive list
** MHRA = UK competent authority, Medicines and Healthcare products Regulatory Agency
The timelines for registration of UK RP and the medical devices/IVD’s they are responsible for have already passed:
• 30 April 2021 for high-risk devices (Class IIb & III implantable devices, AIMD, IVD list A)
• 31 August 2021 for medium risk devices (Class IIa & IIb non-implantable devices, IVD list B, IVD self-testing)
• 31 December 2021 for low-risk devices (Class I and general IVD’s)
The expectation was that most manufacturers would apply for UKCA under UK MDR 2002 (as amended) in late 2022, however, as the new legislation is not expected until 2025 with suspected transition dates thereafter it is expected that manufacturers may push out their submission of their UKCA applications.
As yet, there are only a handful of United Kingdom Approved Bodies (UK AB) designated to review UKCA applications and grant UKCA marking (MHRA website, correct as of 20 Dec 2022):
• BSI Assurance UK Ltd. (0086)
• DEKRA Certification UK Ltd. (8505)
• SGS United Kingdom Ltd. (0120)
• UL International (UK) Ltd. (0843)
Due to the low number of UKAB’s and only a few years to review thousands of devices it is in the interest of manufacturers to apply for UKCA at the earliest opportunity. Whilst the new legislation and the transition times seem to be way in the future it is the small number of designated UK AB’s and their capacities and resources that will be the significant pressure point.
*The manufacturer must have:
• Records of how the device is designed and manufactured.
• Records of how the device meets the relevant requirements.
• The correct labelling
• Compliant PMS and vigilance processes
• A UK declaration of conformity (DoC)
• A list of relevant UK designated standards
*Not an exhaustive list
A signed/dated agreement
Once a manufacturer is in compliance with the current UK legislation then the UKCA can be applied to their device labelling with the addition of a UK CA mark, along with the number of the UK AB (if relevant).
For those manufacturers outside of the UK, once they are in compliance with the UK legislation, the UKRP details (name and address) also need to be applied to their device labelling.
Notes:
• For implantable devices it is thought there may be a future requirement for an implant card
• Dual marking, for example, UKCA and CE mark on the same device is likely to be accepted by the UK authorities
Compliance timelines and therefore company internal labelling changeover timelines.
Ensure continued compliance by keeping up to date with MHRA news for UKCA timelines including labelling.
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