Why the UK is moving toward EU-aligned standards for IVDs
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
The UK’s decision to adopt EU Common Specifications for high-risk in vitro diagnostic (IVD) devices reflects a regulatory shift toward performance-based requirements and alignment with internationally recognised standards. This approach supports public health objectives, replaces legacy mechanisms such as the CTDA, and sets the foundation for a more consistent regulatory framework.
What are Common Specifications under EU IVDR?
Common Specifications (CS) are legally binding sets of technical and performance requirements adopted at the EU level. Under the In Vitro Diagnostic Medical Devices Regulation (IVDR), they apply to specific high-risk devices when harmonised standards are not available or additional regulatory clarity is required.
The scope of these specifications includes IVDs intended for detecting serious infectious diseases such as HIV, hepatitis B, C and D, and syphilis, as well as devices used for blood grouping and tissue typing. These diagnostics are critical for patient management, clinical decision-making, and public health surveillance.
Why is the UK adopting these standards now?
As stated by the UK government, the aim is to establish a performance-driven regulatory model that ensures IVDs meet stringent safety and efficacy thresholds. This move also reflects the outcome of a public consultation in which stakeholders expressed overwhelming support for the repeal of the Coronavirus Test Device Approvals (CTDA) and the adoption of Common Specifications as a replacement.
The government’s position is that aligning with European-level requirements will not only reinforce the scientific rigour of the UK framework but also facilitate operational consistency for manufacturers placing products on both UK and EU markets.
According to Rob Reid, Deputy Director of Innovative Devices at the MHRA:
“By aligning with standards already in place across Europe, we’re not only enhancing patient safety but also making it easier for manufacturers to navigate regulatory requirements across different markets.”
What is changing for COVID-19 test regulation?
The existing CTDA process, implemented during the pandemic to control the quality of COVID-19 tests sold in Great Britain, will be formally repealed. In its place, an interim accelerated CTDA pathway will remain available for COVID-19 tests that:
- Are CE marked under the EU IVDR
- Comply with the relevant EU Common Specifications
This transitional measure is intended to ensure continued access to high-quality COVID-19 diagnostics while the UK prepares for full integration of Common Specifications into its domestic law.
When will these changes take effect?
The government has stated that the new specifications will be introduced in regulations expected to be published later this year. The reforms form part of a broader program to modernise the regulation of medical devices and diagnostics in Great Britain, as outlined by the Medicines and Healthcare products Regulatory Agency (MHRA).
Conclusion
The UK is aligning with the EU’s Common Specifications for high-risk IVDs. This change will replace the CTDA framework, raise performance expectations, and create greater regulatory coherence across UK and EU markets.
At CMC Medical Devices, we support IVD manufacturers in adapting to evolving regulatory frameworks, from CE marking under IVDR to aligning with new UK, specific requirements.
Contact us to schedule a consultation and prepare your documentation for the next phase of UK market access.
These changes were officially announced by the UK government in July 2025 as part of its ongoing regulatory reform programme:
Government to align with European specifications on high-risk in vitro diagnostic devices
