The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Table of content
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a consultation document dedicated to common specification requirements for in vitro diagnostic medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration to ensure compliance.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Consultation Questions
Apart from describing the existing legal framework and providing justification for the ideas behind the changes suggested, the document also contains a list of questions raised by the authority to get feedback from the stakeholders.
The main questions include the following:
- Proposal for Common Specifications for Class D IVDs: The government proposes that the Medical Devices Regulations 2002 (MDR 2002) incorporate Common Specifications for certain Class D in vitro diagnostic devices (IVDs), aligning with the Commission Implementing Regulation (EU) 2022/1107. The public is invited to express their agreement or disagreement with this proposal and provide additional comments if necessary.
- Post-Market Performance Follow-up Plan: The consultation seeks opinions on whether meeting Common Specifications requirements should be mandatory in a Post-Market Performance Follow-up (PMPF) Plan. Respondents can agree, disagree, or provide further comments on this proposal.
- Removal of Requirements for Coronavirus Test Devices: The government proposes to remove the specific requirements for Coronavirus test devices from MDR 2002. Instead, it suggests that COVID-19 test devices undergo a conformity assessment by an Approved Body, meeting Common Specifications requirements consistent with EU regulations for certain Class D IVDs. Public agreement or disagreement with this proposal is sought, along with any additional comments the stakeholders might have.
- Demographic Information: Participants are asked to specify their primary capacity in responding to the survey, whether as individuals sharing personal or professional views or on behalf of an organization. Further questions include the respondent’s professional status, organizational affiliation, and geographical location. For those responding on behalf of organizations, additional details about the organization’s operations, employee count, and product involvement are requested.
- Satisfaction Survey: Participants are invited to provide feedback on their experience with the consultation process in general. Questions focus on the ease of participation and the clarity of supporting information, with options ranging from strong agreement to strong disagreement. A free text box is provided for suggestions on improvements.
Terms and Definitions
Apart from the above, the document also provides definitions of the most important terms and concepts to ensure proper interoperation of the respective legal provisions. For instance, medical devices and in vitro diagnostic medical devices are defined under regulation 2(1) of the UK Medical Devices Regulations 2002, as amended.
The definitions specify the intended use, scope, and function of these devices, highlighting their roles in diagnosis, monitoring, treatment, and more.
Legal Basis and Assessment
The Medicines and Medical Devices Act 2021 provides the legal foundation for proposing these regulatory changes. The Act provides that regulations must prioritize public health, considering the safety and availability of medical devices, and the UK’s attractiveness as a jurisdiction for medical device research, development, manufacturing, and supply.
Assessment of the Proposal
The authority additionally emphasizes the key impact points, including:
- Safety: The Common Specifications policy is expected to enhance the safety profile of high-risk IVD devices, including COVID-19 tests, by ensuring compliance with stringent standards. This is intended to address public health concerns and protect patient safety.
- Availability: By eliminating the need for COVID-19 tests to undergo an additional market access route (the CTDA process), the Common Specifications will streamline regulatory requirements, reducing the burden on manufacturers and ensuring consistent access to the market and availability of such products.
- Favourability: Aligning with the General Safety and Performance Requirements (GSPR) in the IVDR, as supported in the November 2021 consultation, promotes consistency with EU regulations. This alignment is expected to enhance the favourability and availability of the UK market for high-risk IVD devices.
Conclusion
In summary, the proposed adoption of Common Specifications for certain high-risk IVD devices, including COVID-19 tests, is intended to ensure safety, streamline regulatory processes, and maintain alignment with international standards. The present consolation was initiated by the authority due to the public input being crucial in refining and implementing these regulatory changes.
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