April 19, 2022 Medical Device - Clinical


Set A – Essential Actions

No Topic Action Timeline Status
1 Contingency planning and monitoring
1.1 MDCG-level forum for Member States to discuss risks to product  availability    and work on proposed solutions Regular,from   Q4  2020 Ongoing
1.2 Market monitoring exercise (including quantitative information on stakeholder    readiness, barriers to designation and to certification of devices) Regular, from   Q4 2020    Ongoing
1.3 Analyse the IVDR in context of hypothetical scenarios of an urgent response     to a health crisis  Q2 2022    Ongoing
2 Availability of notified bodies
2.1    MS to provide experts for joint assessments  Continuous    Ongoing
2.2 Consider how notified bodies can perform conformity assessment activities       in COVID-19 circumstances Until the end of the pandemic    Notice published
   Monitoring ongoing
2.3    MS discussion on increasing notified body capacity  Continuous    Ongoing

Set B – High Priority Actions

No Topic Action Timeline Status
3.1 Discussion with Member States on practical issues related to EU reference laboratories Continuous     Ongoing
3.2    Implementing acts on tasks and criteria and on fees Q2 2022    In final stages of                adoption
3.3    Survey on expected EURL demand Q1 2021    Completed
3.4    Issue call for application Q2 2022    Draft in revision
3.5    Complete assessment and designate the EURLs Q1 2023    Not yet started
3.6    Investigate Union contribution for tasks not covered by fees Q3-4 2021    Ongoing
4 Common specifications
4.1    Propose which sets of CS will form part of the first adoption round Q1 2021    Completed
4.2    Discuss the text to be adopted in the first adoption round Q1-2 2021    Completed
4.3    Adoption procedure of the first implementing act on common specifications Q2 2022     Ongoing
5 Guidance for notified bodies
5.1    Explanatory note on notified body designation codes Q2 2021    Completed
5.2    Guidance for notified bodies on batch testing Q4 2021    Completed
5.3    Guidance on significant changes referred to in Article 110(3) Q2 2022    Ongoing
5.4    Guidance on “appropriate surveillance” according to Article 110 (3) IVDR Q3 2022    In preparation
6 Performance evaluation and expert panels
6.1    Guidance on clinical evidence for IVDs Q1 2022    Completed
6.2 Clarification on what constitutes a “type of device” and on process to be followed by NBs in context of views of expert panel Q2 2021    Completed
6.3    Template for summary of safety and performance Q2 2022 In preparation for   endorsement
6.4    Template for application/notification for performance studies Q2 2022    Draft in preparation
7 Standards
7.1    Adopt the implementing act on the MDR/IVDR standardisation reques Q2 2021 Adopted by COM and   accepted by   CEN/Cenelec
7.2 Adopt the implementing act on the publication in the OJEU of references of harmonised European standards Q2 2021 1st publication done Q2    2021, 2nd publication   done Q1 2022, 3rd publication foreseen for Q2 2022
8 Companion diagnostics
8.1 Regarding the consultation of medicinal product authorities, accompany the work of the EMA and stakeholders, notably on procedural elements Q1 2022    Ongoing
9 In-house devices
9.1    Guidance on in-house devices Q2 2022 Processing outcome of stakeholder consultation
10 Legacy devices
10.1 Guidance on application of IVDR requirements to legacy devices and those placed on the market before 26 May 2022 Q2 2022    Consultation ongoing
11 Eudamed
11.1 IVDR-specific guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional Q2 2022    Consultation ongoing