UK IVD Alignment

UK Government to Align High-Risk IVD Regulations with EU Standards

Why IVD and Updates matters 🌍

The UK government has revealed plans to harmonise regulatory requirements for high-risk in vitro diagnostic (IVD) devices with the European Union’s Common Specifications— a key move designed to reduce regulatory burdens while upholding patient safety.

These regulations specifically target Class D IVD devices, which include tests for serious infectious diseases (e.g., HIV, Hepatitis B/C/D, Syphilis), blood grouping, tissue typing, and COVID‑19 detection—all crucial tools in modern healthcare.

Key IVD changes at a glance

Area	Before	After
Coronavirus Test Device Approvals (CTDA)	A separate, interim approval pathway since 2020	Abolished; COVID‑19 tests undergo standard conformity assessment via EU specs
Standards for Class D IVD devices	UK-specific requirements under Medical Devices Regulations 2002	EU Common Specifications will guide performance, evidence, sampling, PMPF
Post-Market Performance Follow-up (PMPF)	No binding Common Specification requirement	PMPF now includes ongoing compliance, aligning with EU norms
Transitional COVID‑19 pathway	None for CE-marked EU tests	Introduces a short‑term accelerated route for EU IVDR CE-marked devices

What stakeholders said

A public consultation (20 May–14 June 2024) garnered 39 responses: 92 % backed Common Specifications for Class D IVDs, and 90 % supported ending CTDA in favour of alignment.

While some raised concerns—including the burden of continuous compliance and premature inclusion of COVID‑19 tests—the majority view prevailed that maintaining high‑rigour oversight remains vital, especially given the risk of new SARS‑CoV‑2 variants.

MHRA’s response & next steps

MHRA Deputy Director Rob Reid explained: “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.” 

Next steps include:

• Amending the Medical Devices Regulations 2002 later this year with provisions for Common Specifications and CTDA repeal.

• Issuing clear guidance for manufacturers to support a smooth transition.

• Monitoring availability of high‑risk IVD devices and adjusting implementation if needed.

• Launching an accelerated interim route for CE‑marked COVID‑19 tests aligned with EU IVDR specs.

  
  

Why this is a win–win

1. Reduced duplication: Manufacturers can streamline testing and approval across GB and EU markets.

2. Elevated safety standards: Class D IVDs will now need rigorous clinical justification, analytical performance, and post-market oversight.

3. Regulatory clarity: A unified framework supports both public health and innovation in MedTech.

4. Agile pandemic readiness: The UK retains the flexibility to respond swiftly to COVID‑19 or future threats.

   
   

AF Pharma: Your UK Responsible Person (UKRP)

For non-UK IVD manufacturers needing a UK Responsible Person (UKRP) to access the Great Britain market, AF Pharma—officially MHRA-approved—offers full compliance support. They assist with registering devices, maintaining technical documentation, managing MHRA liaison, handling post-market vigilance, and securing UKCA marking. Learn more on their site: https://www.afpharmaservice.com/ukrp-medical-device

In summary

This shift underscores the UK’s commitment to regulatory alignment with Europe—delivering a simpler, faster, and safer landscape for high-risk diagnostic devices. By adopting EU Common Specifications, abolishing CTDA, and reinforcing post-market oversight, the UK is paving the way toward a future-ready IVD regulatory regime.

📌 Expect updated regulations and manufacturer guidance later this year. In the meantime, services like those from AF Pharma offer essential support for navigating these changes.

The UK government has announced its decision to align the regulatory requirements for high-risk in vitro diagnostic (IVD) devices—such as HIV, hepatitis, and COVID-19 tests—with the European Union’s Common Specifications, replacing the CTDA process and introducing a transitional route for CE-marked COVID-19 tests. This alignment reduces the regulatory burden while maintaining patient safety, offering manufacturers a clearer and more efficient pathway to market. If you're a non-UK manufacturer, AF Pharma can act as your UK Responsible Person (UKRP), handling MHRA registration, technical documentation, and post-market vigilance with flat-fee pricing and expert support. Learn more about AF Pharma’s UKRP services here: www.afpharmaservice.com/ukrp-medical-device.

🔗 Sources: GOV.UK Press Release, GOV.UK Consultation Outcome.