MHRA Proposes Common Specifications for High-Risk IVD Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed future amendments to the Medical Devices Regulations 2002 (MDR 2002). These amendments would introduce common specifications requirements for high-risk in-vitro diagnostic (IVD) devices, aiming to align with the General Safety and Performance Requirements (GSPR) of the In Vitro Diagnostic Regulation (IVDR). This initiative includes specific requirements for COVID-19 test devices as part of the Medical Device Regulations 2021. 

The common specifications concept is akin to the common technical specifications already applicable to certain high-risk IVD devices under the current MDR 2002. The proposed amendments will update the IVD classification system to a risk-based approach, categorizing devices from Class A (lowest risk) to Class D (highest risk). MHRA proposes to implement Common Specifications requirements for specific Class D IVD devices under future regulations. 

Proposal Highlights: 

1. Introduction of Common Specifications for Class D IVD Devices: 

• • • Align with EU Commission Implementing Regulation 2022/1107. 

2. Incorporation into Post Market Performance Follow-Up (PMPF): 

• • • Include Common Specification requirements as part of the PMPF process. 

3. Removal of COVID-19 Test Device Requirements from MDR 2002: 

• • • Avoid regulatory duplication, ensuring manufacturers only comply with Common Specifications for SARS-CoV-2 tests instead of the Coronavirus Test Device Approvals requirements in MDR 2002. 

For further details, you can access the full consultation document, which includes the consultation questions at the end: Consultation Document: Common Specification Requirements for In Vitro Diagnostic Devices. 

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If you have any question about the MHRA’s proposed future amendments to common specifications requirements for high-risk in-vitro diagnostic (IVD) devices, contact us so our consultants can assist you.

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