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 | EURLs | |||
| 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 | |