In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its joint plan on the preparedness and implementation of the In Vitro Diagnostic Regulation (IVDR). Despite the progress made – as explained in the last release of the Plan, the transition from the IVD Directive presents a significant challenge to stakeholders.
For this reason, the joint plan has two parts. Specifically, part A focuses on actions that are vital for devices to have access to the market. Part B addresses legislation and guidance documents that facilitate the work of stakeholders.
In particular, the Annex of the plan lists the following actions, indicating their timeline and status:
SET A – ESSENTIAL ACTIONS
1. Contingency planning and monitoring
- MDCG–level forum for Member States to discuss risks to product availability and work on proposed solutions. Regular, from Q4 2020.
- Market monitoring exercises. Regular, from Q4 2020.
- To analyse the IVDR in the context of hypothetical scenarios of an urgent response to a health crisis. Expected Q4 2022.
2. Availability of notified bodies
- Member States to provide experts for joint assessments. Continuous.
- MDCG to consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances. Until the end of the pandemic. Notice published.
- Member States to discuss on notified body capacity. Continuous.
SET B – HIGH PRIORITY ACTIONS
3. EU Reference Laboratories (EURLs)
- Discussion with Member States on practical issues related to EU reference laboratories. Continuous.
- Implementing acts on tasks and criteria and on fees. Completed
- Survey on expected EURL demand. Completed
- Issue call for application. Completed
- Complete assessment and designate the EURLs. Expected Q3 2023
- Investigate Union contribution for tasks not covered by fees. Expected Q3 2023
4. Common specifications
- Propose which sets of CS will form part of the first adoption round. Completed
- Discuss the text to be adopted in the first adoption round. Completed
- Adoption procedure of the first implementing act on common specifications. Completed
5. Guidance for notified bodies
- Explanatory note on notified body designation codes. Completed
- Guidance for notified bodies on batch testing. Completed
- Guidance on significant changes referred to in Article 110(3). Completed
- Guidance on “appropriate surveillance” according to Article110 (3) IVDR. Completed
6. Performance evaluation and expert panels
- Guidance on clinical evidence for IVDs. Completed
- Clarification on what constitutes a “type of device” and on process to be followed by NBs in context of views of expert panel. Completed
- Template for summary of safety and performance. Completed
- Template for application/notification for performance studies. Ongoing
7. Standards
- Adopt the implementing act on the MDR/IVDR standardisation request. Adopted by COM and accepted by CEN/Cenelec
- Adopt the implementing act on the publication in the OJEU of references of harmonised European standards. 4th publication foreseen Q4 2022
8. Companion diagnostics
- Regarding the consultation of medicinal product authorities, accompany the work of the EMA and stakeholders, notably on procedural elements. Completed
9. In-house devices
- Guidance on in-house devices. In preparation for endorsement
10. Legacy devices
- Guidance on application of IVDR requirements to legacy devices and those placed on the market before 26 May 2022. Completed
11. Eudamed
- IVDR-specific guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. Completed
Full text of the Joint Implementation Plan as well as the above-mentioned guidance documents are available in our Library of Documents – MDCG.
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