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Listed below are some of the most recent publications supporting the implementation of the EU IVDR.
February 2025:
January 2025:
- Update of MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts.
- News announcement: New guidance available on the EMDN (European Medical Device Nomenclature).
- News announcement: Revised templates and forms available to the Notified Bodies.
December 2024:
- (New) First publication of MDCG 2024-16 - Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices.
November 2024:
- (New) First publication of Gradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 (November 2024).
- Update of MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746.
October 2024:
- (New) First publication of Q&A - Obligation to inform in case of interruption or discontinuation of supply.
- (New) First publication of MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices.
September 2024:
- Update of MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices.
July 2024:
- Update of MDCG 2020-16 Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
- Update of MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices.
June 2024:
- (New) Publication, in the Official Journal, of Regulation (EU) 2024/1860 implementing a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
- Update of SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.