Updated EC Implementation Rolling Plan (MDR/IVDR)

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 specificationsfor products without amedical purpose

 

Articles 1(2) and 9(1)MDR
Commission implementing actCommon specifications (CS) addressing for any of the groups of products listed in AnnexXVI of the MDR, at least, application of risk management as set out in Annex I and, wherenecessary, clinical evaluation regarding safety. Application of MDR to Annex XVI productsdepends on the adoption of CS.
Expected date of final adoption/accomplishment: Q4 2022
In progress.

The Committee on Medical Devices delivered a positiveopinion on 13 October 2022. The adoption procedure isongoing.

Reclassification of certain Annex XVI active products
Article 51(3)
Commission implementing acton 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 positiveopinion on 13 October 2022. The adoption procedure isongoing.

Setting up of newstructures under IVD:- EU referencelaboratories
recital 94Articles 48(6), 100(1)and (3) IVDR, Article113(d) IVDR
Implementing Act (no comitology involved)Designation of EU reference laboratories, active in the IVD field. Tasks are described inArticle 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 DeviceIdentification (UDI)System
Article 27 (10) (b)
Commission Delegated Regulation on UDI assignment criteria for highly individualiseddevices (contact lenses)
Expected date of final adoption/accomplishment: Q1 2023
In progress.

Eudamed: Audit offunctional specificationsand publication of thenotice of full functionality
Article 34(2) and 34(3)MDR
Independent audit report based on which the Commission shall inform the MDCG thatEudamed has achieved full functionality and meets the drawn up functionalspecifications. Publication of the notice of achieved full functionality.
Expected date of final adoption/accomplishment: Q1/Q2 2024
In progress.

 

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