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:
EUDAMED go-live | Article 34 MDR | Eudamed may go-live from the moment a notice is published in the Official Journal of the European Union after a positive independent audit was performed that satisfies the MDCG | Notice to be published in 2022. | Deployment of fully functional EUDAMED intended to take place in 2022.
In agreement with the MDCG, the Commission has pledged to make available the six modules on a roling basis as soon as each module becomes operational. |
Standardisation Request | Article 10 of Regulation (EU) No 1025/2012 (the ‘Standardisation Regulation’) | Request to the relevant European Standardisation Organisations (CEN and CENELEC) for development of standards in the field of medical devices in support of the new Regulations – the existing standards harmonised under the current Medical Device Directives need to be aligned to the new framework. | Commission Implementing Decision adopted on 15 May 2020 and notified to CEN and CENELEC on 18 May 2020 for their acceptance. | Acceptance under discussion in CEN and CENELEC. Deadline for the decision: 17 June 2020. |
Common specifications for IVD Class D | Article 9 and 48(6) IVDR | Commissioin implementing act
Common Specifications for IVD Class D in the context of the scrutiny mechanism for high risk devices |
Q3 2020 | In planning. |
Reprocessing of single-use medical devices | Article 17(5) MDR | Commission implementing act
Common specifications laying down requirements related to reprocessing of single-use devices concerning: — risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing, — the validation of procedures for the entire process, including cleaning steps, — the product release and performance testing, — the quality management system, — the reporting of incidents involving devices that have been reprocessed, and — the traceability of reprocessed devices. |
Q3 2020 | Undergoing formal adoption procedure. |
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. |
Q4 2020 | In planning. |
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