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UK MHRA Publishes Common Specification Requirements for IVD Devices

Do you have IVDs on the UK market? Read our analysis of the outcome of the UK medical device regulator’s consultation and its impact on IVDs.

London Bridge at dusk

July 10, 2025

By Karen Hill

The Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation from May 20 to June 14, 2024, on their proposed amendments to the Medical Devices Regulations 2002 (MDR 2002) regarding the Common Specifications (CS) requirements for certain high-risk in vitro diagnostic (IVD) devices, including COVID-19 tests. In this blog, we discuss the outcome of the consultation and the impact on your business as it places IVDs on the market in the UK. 

The consultation on high-risk IVDs

The consultation proposed to amend the Medical Devices Regulation 2002 (MDR 2002) to incorporate the common specifications (CS) set out in the Commission Implementing Regulation (EU) 2022/1107, and to require manufacturers to meet those CS as a condition for placing their devices on the Great Britain market. In addition, they also sought views on the removal of the Coronavirus (SARS-CoV-2) Test Device Approval (CTDA) process (desktop review) to avoid duplication with the CS requirements.

The consultation comprised three questions:

  1. “Do you agree that the CS for certain Class D IVDs, as set out in Commission Implementing Regulation (EU) 2022/1107, should be incorporated into the UK Medical Devices Regulation 2002?
  2. Do you think meeting CS requirements should be a requirement in a Post Market Performance Follow-up Plan?
  3. The government proposes removing the requirements for coronavirus test devices from the MDR 2002. The government proposes to require COVID-19 test devices to undergo a conformity assessment by an Approved Body, meeting common specification requirements in line with Commission Implementing Regulation (EU) 2022/1107, the EU Common Specifications for Certain Class D IVDs.”

Results of the consultation

A total of 39 responses were received from a diverse range of respondents, including IVD manufacturers, healthcare professionals, trade associations, academic institutions, public bodies, patient groups, and individuals from various locations both within and outside the UK.

Of 39 respondents, 92% agreed with the proposal that the MDR 2002 should include CS for certain Class D IVD devices, as set out in the Commission Implementing Regulation (EU) 2022/1107.

Further, 82% of respondents agreed that CS requirements must be in a Post-Market Performance Follow-up Plan.

MHRA intends to incorporate CS

Having considered all responses and taking concerns raised into account, the MHRA intends to amend the MDR 2002 to incorporate the CS for certain Class D IVDs, and to require manufacturers to meet those CS as a condition for placing their devices on the Great Britain market. CS will only apply to Class D IVDs where there is a significant risk associated with the use of the device for public health and patient safety. In addition, the proposal to include CS requirements in the PMPF will be implemented in the future, but will not be more stringent than what is required in Northern Ireland and the EU.

Coronavirus test device approvals

The Coronavirus (SARS-CoV-2) Test Device Approval (CTDA) process (desktop review) was introduced in April 2020 as an interim measure to support the availability of safe COVID-19 tests in response to the pandemic. Regarding the proposal to remove the process, 90% of respondents agreed with the proposal, and as a result, the MHRA intends to remove the CTDA process and introduce CS requirements for high-risk IVD devices.

Timeline for implementation

Implementation of the proposed updates will be incorporated into the new pre-market SI, currently anticipated to become effective in 2026. In the interim, an accelerated CTDA process will be introduced for COVID-19 devices that have CE marking under the European IVD Regulations (EU IVDR) and meet CS requirements.

Goal: improved safety and quality

The MHRA believes that the adoption of the CS will improve the safety and quality of certain high-risk IVDs, provide consistency and harmonization across Great Britain and Northern Ireland markets, align Great Britain with the international standards and best practices for IVD regulation, and benefit the healthcare system and public health by confirming the safety of certain high-risk IVDs.

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