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:
| Common specifications for products without a medical purpose |
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: Q1 2022. | In progress. |
| 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: Q1-2 2022. | In preparation. |
| Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria |
Article 100(8)(a | 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: Q3 2021. |
In progress. |
| Fees for EURL service | Article 100(8)(b) IVD | 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: Q3 2021. |
In progress. |
| Eudamed | Article 33(8) MDR Article 30(1) IVDR |
Commission implementing act Definition of detailed arrangements necessary for the setting up and maintenance of Eudamed. This IA is mainly related to support, change management and maintenance rules. |
Expected date of final adoption/accomplishment: Q3 2021. |
In progress. |
| Common specifications for IVD Class |
Article 9 and 48(6) IVDR |
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: Q2-3 2021. |
In progress. |
| Harmonised standards in support of MDR and IVDR | Articles 8(1) of the MDR and IVDR and correlative |
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. |
Expected date of final adoption/accomplishment: Q4 2021, Q1-2 202. |
First lists for MDR and IVDR, published in the OJEU on 19 and 20 July 2021 respectively. New publications, in progress. |
| Eudamed: drawing up of functional specifications | Article 34(1) MDR | Functional specifications for Eudamed, to be drawn up by the Commission, in cooperation with the MDCG. | Expected date of final adoption/accomplishment: Q1 2019 (high-level functional specifications). |
High-level functional specifications publically issued on the Commission website in March 2019. |
| 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 functionali | Expected date of final adoption/accomplishment: Q1/Q2 2023. |
Pending; (first three modules: Actor, UDI Device and NBs and Certificates are/will be made available as soon as functional.) |
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