Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination Group (MDCG) has released a Joint Implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) to ensure an operational system before 26 May 2022 – the date of application of the IVDR.
The Joint Implementation Plan establishes two sets of priorities based on the objectives of public health, patient safety and transparency, which are urgent matters for stakeholders and key to the IVDR. In addition, it sets out concrete actions to promote collaboration between EU stakeholders, the European Commission and the Member States and to ensure an optimal implementation of the legal framework of the new legislation within the limits of the available resources.
Set A focuses on priority actions to allow manufacturers to place their devices on the market. It includes actions related to:
- A framework for contingency planning and monitoring
- Engage in an MDCG-level forum to communicate on critical issues related to IVDR implementation, on potential risks of shortages and measures taken to ensure availability of safe and critical IVDs. (Commission, MDCG)
- Perform a market monitoring exercise to obtain as much data as possible on the preparedness of different stakeholders and aiming at detecting possible barriers that could lead to shortage of devices on the market (Commission, CAMD)
- Analyse the IVDR in the context of hypothetical scenarios of an urgent response to a health crisis, scenarios to consider and methodology to be defined (Commission, MDCG IVD WG)
- Availability of notified bodies
- Make available national experts for joint assessment of notified bodies( Member States)
- Consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances (Commission, MDCG)
- Designation of EU reference laboratories
- Discussion with Member States on practical aspects related to EU reference laboratories (Commission, MDCG/MDCG IVD WG?)
- Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories (Commission, Committee on Medical Devices)
- Carry out survey on needed capacity of EU reference laboratories (Commission)
- Issue call for application to Member States and the Joint Research Centre (Commission)
- Assess the applications and designate the EU reference laboratories (Commission)
- Investigate a Union contribution for tasks that are not covered by fees (Commission)
Set B describes high priority actions to facilitate the work of the involved economic operators, including:
- Common specifications
- Propose the sets of CS will form part of the first adoption round (Commission)
- Agree on the text to be adopted as part of the first round (MDCG IVD WG, MDCG, Commission)
- Adopt the first implementing act containing common specifications (Commission, Committee on Medical Devices)
- Guidance for notified bodies
- Complete and endorse guidance on notified body designation codes. (MDCG NBO WG, MDCG IVD WG, Commission, MDCG)
- Complete and endorse guidance on batch testing for notified bodies (MDCG NBO WG, MDCG IVD WG, Commission, MDCG
- Performance evaluation and expert panels
- Complete and endorse guidance on performance evaluation. (MDCGIVD WG, MDCG CIE WG, MDCG)
- Develop and endorse a clarification on what constitutes a “type of device” and on the process to be followed by notified bodies in context of views of the expert panel. (MDCG NBO WG, MDCG IVD WG, MDCG)
- Develop and endorse template for summary of safety and performance (MDCG IVD WG, MDCG CIE WG, MDCG
- Standards
- Adopt the implementing action the MDR/IVDR standardisation request (Commission, Committee on Standards) and accept it (CEN/CENELEC)
- Adopt the implementing act on the publication in the OJEU of references to harmonised European standards in support of the IVDR requirements (Commission)
- Companion diagnostics
- Regarding the consultation of medicinal product authorities, accompany the work of the EMA and stakeholders, notably on procedural elements (MDCG IVD WG, medicinal product authorities, EMA)
- In-house devices
- Develop guidance explaining the provisions on in-house devices (MDCG IVD WG, MDCG MS WG)
The Annex of the Plan contains a summary of the actions, including an indicative timeline that must be completed by the date of application of the IVDR.
It is also noted that cooperation and collaboration between the actors on market surveillance and vigilance is necessary to ensure safety on the market and further guidance in the areas of performance studies, summary of safety and performance, in-house devices, companion diagnostics and qualification of devices used in clinical trials of medicinal products is expected to be provided.
Furthermore, the Commission will regularly update MDCG on the overall progress towards full functionality of EUDAMED. Additional guidelines on resources optimization and coordination with and between MDCG sub-groups will be needed within the next year.
Full text of the Joint Implementation Plan is available in our Library of Documents – MDCG.
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