MDCG Joint Implementation plan on IVDR

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:


1. Contingency planning and monitoring

  • MDCGlevel 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 assessmentsContinuous
  • 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.


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 feesExpected 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 IVDsCompleted
  • 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 requestAdopted 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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