Today the UK MHRA released a new guidance document on how to market IVD devices in Great Britain: HERE

Brief Introduction

• • The current UK legislation (UK Medical Device Regulation (MDR) 2002, as amended) is based on the old European Directives – MDD/AIMDD/IVDD.
    • If a company complies with the UK MDR 2002, then the device is UKCA Marked.
    • For more information, please read: UKCA Marking Fact Sheet for Medical Devices & IVDs

• • The MHRA currently accepts EU CE Marking.
    • For IVDs, this acceptance lasts until 30 June 2030, as long as the device continues to comply with the applicable EU legislation. I.e., as an IVDD legacy device or IVDR device.
    • The UK MDR 2002 has been amended to reflect the acceptance of CE Marked devices onto the market; however, this does not mean that the devices are considered UKCA Marked. UKCA Marking is still a distinct and separate process.

• • New UK legislation is expected to be implemented in July 2025. It will be more robust and will align with (though not identical to) the EU MDR/IVDR.
  • Companies may voluntarily UKCA Mark prior to 1) the new legislation or 2) before the CE Marking acceptance period ends. However, they are not obliged to do so.
    • For more information, please read: Is there any advantage to UKCA Marking early?

• • Medical devices & IVDs require registration with the MHRA prior to being marketed. Non-UK companies must appoint a UK Responsible Person (UKRP) that will complete the registration on the manufacturer’s behalf.
    • For more information, please read: UK MHRA Registration

What is included in the new MHRA IVD Guidance?

The definition of IVDs

Including, specimen receptacles are considered IVDs, and products for general laboratory use are not IVDs unless they are specifically intended to be used for in vitro diagnostic examination of samples derived from the human body for the purposes outlined in the definition of an IVD.

Requirements for devices for performance evaluation

Including, while they are not subject to normal conformity assessment procedures, they do still require registration with the MHRA.

Certified reference materials

Confirms that while they, and those materials used for external quality assurance schemes, are not covered by the UK MDR 2002, that calibrators and control materials needed to establish or verify the performance of devices are IVDs.

Trade fairs

IVDs that are not in compliance with the legislation may still be shown at trade shows, exhibitions, and scientific gatherings, as long as 1) are not used on specimens taken from participants and 2) a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the UK MDR 2002.

Classification

Same as under the EU IVDD, the classification scheme for UKCA Marking is:

• General IVDs, i.e., all IVDs other than those covered below (“self-certified” by the manufacturer)
• IVDs for self-testing (requires certification through a UK Approved Body)
• IVDs identified in Annex II, List B (requires certification through a UK Approved Body)
• IVDs identified in Annex II, List A (requires certification through a UK Approved Body)

The MHRA notes:

“It is possible that Annex II Lists A and B (Part IV of the UK MDR 2002, as modified by Part III of Schedule 2A) may be amended or extended in the future.”

See pages 10 & 11 for flowcharts of the UKCA Marking pathway for each classification.

Registration

A manufacturer who “places a relevant device on the Great Britain market, or who makes available a device for performance evaluation under their own name must register the device(s) with the MHRA prior to it being placed on the market.”

UK Responsible Person

Manufacturers who “do not have a registered place of business in the United Kingdom must designate a UK Responsible Person to perform certain obligations (e.g., to make certain documentation available on request) (Regulation 33A).”

Additional legislation that may apply to IVDs

The Health and Safety at Work Act 1974

The Radioactive Material (Road Transport) (Great Britain) Regulations 2002