The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different statuses: pending, in preparation, published, completed. The whole document is accessible here, and some important points here below:
| Subject | Legal basis | Description | Expected timelines | State-of-play/Next step |
| Common specifications for products without a medical purpose |
Articles 1(2) and 9(1) |
Commission implementing act Common specifications (CS) addressing for any of the groups of products listed in Annex XVI of the MDR, at least, application of risk management as set out in Annex I and, where necessary, clinical evaluation regarding safety. Application of MDR to Annex XVI products depends on the adoption of CS. |
Expected date of final adoption/accomplishment: Q4 2022 | In progress.
The Committee on Medical Devices delivered a positive |
| Reclassification of certain Annex XVI active products | Article 51(3) | Commission implementing act on reclassification of groups of active products without an intended medical purpose, by way of derogation from Annex VIII to Regulation (EU) 2017/745 of the European Parliament and of the Council. |
Expected date of final adoption/accomplishment:
Q4 2022 |
In progress.
The Committee on Medical Devices delivered a positive |
| Setting up of new structures under IVD: – EU reference laboratories |
recital 94 Articles 48(6), 100(1) and (3) IVDR, Article 113(d) IVDR |
Implementing Act (no comitology involved) Designation of EU reference laboratories, active in the IVD field. Tasks are described in Article 100. Designation may take place no earlier than 25 November 2020, according to IVDR Article 113(d) |
Expected date of final adoption/accomplishment: Q3 2023 | In preparation. |
| Unique Device Identification (UDI) System |
Article 27 (10) (b) | Commission Delegated Regulation on UDI assignment criteria for highly individualised devices (contact lenses) |
Expected date of final adoption/accomplishment: Q1 2023 | In progress. |
| Eudamed: Audit of functional specifications and publication of the notice of full functionality |
Article 34(2) and 34(3) MDR |
Independent audit report based on which the Commission shall inform the MDCG that Eudamed has achieved full functionality and meets the drawn up functional specifications. Publication of the notice of achieved full functionality. |
Expected date of final adoption/accomplishment: Q1/Q2 2024 | In progress. |
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