Since Brexit, manufacturers seeking to place medical devices on the Great Britain market (England, Wales, and Scotland) must comply with UK-specific regulations. While EU conformity routes remain accepted, allowing CE-marked medical devices to enter the Great Britain market, manufacturers based outside the UK are still required to appoint a UK-based Responsible Person and register their devices locally.
Steps to enter the UK market
Manufacturers intending to sell medical devices in Great Britain should:
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- Assess whether their devices qualify for self-declaration or require third-party conformity assessment.
- Choose either the CE marking or the UKCA marking as a conformity assessment route:
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- Manufacturers can use UKCA marking to declare compliance with the UK regulations. It is important to note that the EU, EEA, or Northern Ireland do not recognise the UKCA marking, where a CE marking remains necessary.
- CE marking is accepted if the device fully complies with EU regulations (e.g. MDR or IVDR).
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- Appoint a UK Responsible Person to fulfil compliance responsibilities (applicable to non-UK manufacturers).
- Register their devices with the Medicines and Healthcare products Regulatory Agency (MHRA), before market placement. For non-UK manufacturers, the UK responsible person registers the devices.
How to achieve UKCA marking
The process for obtaining the UKCA marking varies depending on the classification of the medical device:
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- Self-declaration for class I devices and general IVDs
Manufacturers of class I medical devices that are non-sterile and without a measuring function, as well as general in vitro diagnostic devices, can self-declare conformity to the UK Medical Device Regulations (UK MDR 2002).
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- Third-party assessment for higher-risk class devices
Class I devices that are sterile or include a measuring function, as well as higher-class devices, must undergo a conformity assessment by a UK Approved Body. For in vitro diagnostic devices (IVDs), UK Approved Body involvement is not determined by risk class but rather by specific criteria. These include devices listed in Annex II, List A (e.g., devices for testing high-risk infections or blood group typing) and List B (e.g., devices for detecting certain infectious diseases), as well as IVDs intended for self-testing. These third-party assessment bodies, designated by the MHRA, are responsible for evaluating whether manufacturers comply with the requirements of the Medical Devices Regulations 2002.
Current transitional measures for CE-marked medical devices
The UK government has extended the acceptance of CE-marked devices beyond the initial deadline of 30 June 2023. To facilitate the transition, MHRA has introduced new timelines, providing manufacturers with additional time to adopt UKCA marking for medical devices and in vitro diagnostic devices:
Source of images: MHRA, GOV.UK
Role of the UK Responsible Person
Non-UK manufacturers are required to appoint a UK Responsible Person (UKRP), to manage compliance-related obligations within Great Britain. Obelis UK, as UK Responsible Person, plays a critical role in ensuring regulatory adherence, including:
Device registration: The UKRP must register all devices with the MHRA before they are placed on the Great Britain market.
Conformity assessment verification: The UKRP is responsible for verifying that the correct conformity assessment procedure has been applied and ensuring that the Declaration of Conformity (DoC) and Technical Documentation (TD) are properly drawn up.
Document availability: The UKRP ensures that the DoC, TD, and any required certificates are maintained and readily available for inspection by the MHRA.
Communication and incident management: The UKRP acts as a liaison with the MHRA, providing any requested information or documentation and facilitating access to devices or samples. Additionally, the UKRP is responsible for reporting incidents or complaints to the manufacturer.
Regulatory compliance enforcement: If the manufacturer fails to meet its regulatory obligations, the UKRP must terminate their relationship and notify the MHRA and, where applicable, the relevant Approved Body. It is important to note that while CE marking can be used to access the UK market, manufacturers will still need to appoint a UKRP.
Do you have any questions about compliance requirements for MDs and IVDs in the UK?
Meric Gonul
Regulatory Intelligence & Innovation
25/11/2024
Reference:
MHRA (2020, updated: 2024) Guidance on regulating medical devices in the UK. Retrieved on 18.11.2024.