The MDCG has released the updated Joint implementation and preparedness Plan for IVDR noting significant progress has been achieved. For example,
- The necessary implementing acts and administrative arrangements enabling the designation of notified bodies have been put in place. Six notified bodies have been designated as of October 2021 and further applications are being processed.
- The Unique Device Identifier system has been set up.
- The Eudamed database is under development.
- The IVD expert panel has been designated and experts appointed.
- A number of new common specifications are in development.
- Many guidance documents either have been published or are in a mature preparation stage. (MDCG, 2021)
The Implementation plan itself is divided in two sets of priorities. Set A includes actions that are essential for devices to have access to the EU market, while 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 as well as 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): Q1 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): Q4 2021
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?): Q1 2021
- Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories (Commission, Committee on Medical Devices): Q1 2022
- 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): Q1 2022
- 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
SET B– HIGH PRIORITY ACTIONS
- 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: Q1 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): Q4 2021
- Develop guidance on significant changes as referred to in Article 110(3) of IVDR (MDCG NBO WG, MDCG IVD WG, Commission, MDCG): TBC
Performance evaluation and expert panels
- Complete and endorse guidance on performance evaluation. (MDCG IVD WG, MDCG CIE WG, MDCG): Q1 2022
- 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: Q1 2022
- 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, next Q4 2021 and Q1-2 2022
- 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 2021
- Develop guidance explaining the provisions on in-house devices (MDCG IVD WG, MDCG MS WG): Q1 2022
You can find the full text of the Join Implementation and preparedness plan in our dedicated IVDR Library – MDCG.