The European Commission published its update from March of the Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining the priorities and actions to be completed by the Member States and the European Commission services. Despite significant progress achieved on many aspects – as explained in the last release of the Plan, the document states that the IVDR implementation remains a ”very challenging task”.
The Implementation plan itself is divided into two sets of priorities. Set A includes actions that are essential for devices to have access to the EU market. In contrast, Set B includes legislation and guidance documents, which are not obligatory, but fundamentally assist in the implementation. Here below, we list priority actions, responsible entity, and the timeline.
SET A – ESSENTIAL ACTIONS
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): Regular, from Q4 2020
- 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): Regular, from Q4 2020
- 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): Q2 2022
Availability of notified bodies
- Make available national experts for joint assessment of notified bodies (Member States): Continuous
- Consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances (Commission, MDCG): Until the end of the pandemic
- Member State discussion on increasing notified body capacity (MDCG, MDCG NBO WG, MDCG IVD WG, Commission): Continuous
SET B– HIGH PRIORITY ACTIONS
EU reference laboratories (nominated by the EU Member States)
- Discussion with Member States on practical aspects related to EU reference laboratories (Commission, MDCG/MDCG IVD WG): Continuous
- Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories (Commission, Committee on Medical Devices): Q2 2022 – In final stages of adoption
- Carry out survey on needed capacity of EU reference laboratories (Commission): Completed
- Issue call for application to Member States and the Joint Research Centre (Commission): Q2 2022 – Draft in revision
- Assess the applications and designate the EU reference laboratories (Commission): Q1 2023
- Investigate a Union contribution for tasks that are not covered by fees (Commission): Q3-Q4 2021
Common specifications
- Propose the sets of CS will form part of the first adoption round (Commission): Completed
- Agree on the text to be adopted as part of the first round (MDCG IVD WG, MDCG, Commission): Completed
- Adopt the first implementing act containing common specifications (Commission, Committee on Medical Devices): Q2 2022
Guidance for notified bodies
- Complete and endorse guidance on notified body designation codes. (MDCG NBO WG, MDCG IVD WG, Commission, MDCG): Completed
- Complete and endorse guidance on batch testing for notified bodies (MDCG NBO WG, MDCG IVD WG, Commission, MDCG): Completed
- Develop guidance on significant changes as referred to in Article 110(3) of IVDR (MDCG NBO WG, MDCG IVD WG, Commission, MDCG): Q2 2022
- Develop guidance on appropriate surveillance as referred to in Article 110(3) of the IVDR (MDCG NBO WG, MDCG IVD WG, Commission, MDC): Q3 2022
Performance evaluation and expert panels
- Complete and endorse guidance on clinical evidence for IVDs. (MDCG IVD WG, MDCG CIE WG, MDCG): Completed
- 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): Completed
- Develop and endorse template for summary of safety and performance (MDCG IVD WG, MDCG CIE WG, MDCG: Q2 2022 – In preparation for endorsement
- Develop and endorse template for application/notification of performance studies. (MDCG CIE WG, MDCG IVD WG, MDCG): Q2 – Draft in preparation
Standards
- Adopt the implementing act on the MDR/IVDR standardisation request (Commission, Committee on Standards) and accept it (CEN/CENELEC): Adopted by Commission and accepted by 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): First publication done Q2 2021, 2nd in Q1 2022 and third publication foreseen for Q2 2022
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): Q1 2022
In-house devices
- Develop guidance explaining the provisions on in-house devices (MDCG IVD WG, MDCG MS WG): Q2 2022
Legacy devices
- Develop and endorse a guidance document on the application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (MDCG IVD WG, MDCG NBO WG, MDCG PMSV WG, MDCG MS WG, MDCG): Q2 2022
Eudamed
- Develop and endorse IVDR–specific guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (MDCG Eudamed WG, MDCG IVD WG, MDCG): Q2 2022
You can find the full text of the Join Implementation and preparedness plan in our dedicated IVDR Library – European Commission.
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