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Unofficial consolidated textConsolidated 2026-01-01English

Article 26

Reproduced from official EUR-Lex 1/1/2026.

Official catalogue · non-binding

Related guidance (9)

Current English catalogue entries that refer to Article 26. Guidance is non-binding and kept separate from the regulation text.

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MDCG 2020-7Guidance on PMCF plan templateApril 2020
MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022
Gradual roll out of EUDAMEDQ&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 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards 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 devices1November 2024
MDCG 2024-2 rev.1Procedures for the updates of the EMDNJanuary 2025
MDCG 2021-12 rev.2FAQ on the European Medical Device Nomenclature (EMDN)April 2026
MDCG 2018-2Future EU medical device nomenclature - Description of requirementsMarch 2018
MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022
MDCG 2021-19Guidance note integration of the UDI within an organisation’s quality management systemJuly 2021
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MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018

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