The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts and actions to take with different statuses: in progress, in preparation, published, completed. The document is accessible here, and we highlight some important points below:
| Common specifications for products without a medical purpose (Annex XVI products) |
Articles 1(2) and 9(1) MDR | 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: Updated information to be provided following the next meeting of the Committee on Medical Devices. |
Discussions ongoing within the Committee on Medical Devices. Minutes of the meetings, voting sheets and drafts of the voted measures are available online on the Comitology register website. A new meeting of the committee will be convened in September 2022 |
| 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: Updated information to be provided following the |
In preparation. |
| Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria |
Implementing Act Rules to facilitate application of IVDR Article 100 (2) listing the tasks of the EURLs; rules to ensure compliance with criteria for an EURL listed in IVDR Article 100 (4). Date of application of the act may not be earlier than 25 November 2020 according to IVDR Article 113(d). |
Expected date of final adoption/accomplishment:
Q2 2022 |
Completed. |
| Fees for EURL service | Implementing Act Definition of rules for fees for the advice/testing activities performed by EURL. Date of application of the act may not be earlier than 25 November 2020 according to IVDR Article 113(d). |
Expected date of final adoption/accomplishment: Q2 2022 |
Completed. |
| Setting up of new structures under IVDR: – 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:
Q1 2023 |
In preparation. |
| Common specifications for IVD Class |
Commission implementing act Common Specifications for certain IVDs in class D. Important to facilitate conformity assessment by manufacturers, notified bodies, expert panels and EU reference laboratories. |
Expected date of final adoption/accomplishment:
Q2 2022 |
Completed. |
| Harmonised standards in support of MDR and IVDR | Articles 8(1) of the MDR and IVDR and correlatives |
Commission implementing decisions Periodical publication in the OJEU of lists of references of harmonised standards to confer presumption of conformity with the requirements of the new Regulations the standards aim to cover. |
Expected date of final adoption/accomplishment: Q2 2021, Q4 2021 Q2 2022. Q4 2022 |
Completed.
MDlaw: Click here for more info on MDR, IVDR! |
| 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 fucntionality |
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 |
Development of the Minimum Viable Product (MVP) scope is ongoing and must be finalised before the audit can be performed.
Audit of MVP planned for Q2 2022. MDlaw: Click here. For already available modules on Actor and Device registration. |
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