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Accueil DM-DIV DM DIV Europe Europe – Ongoing consultations under the PECP
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  • DM DIV Europe

Europe – Ongoing consultations under the PECP

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20/09/2023
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6) of Regulation (EU) 2017/746, as well as the completed templates describing the types of device for which consultations under the PECP are ongoing (see guidance document MDCG 2021-22…

SourceRead more - European Commission
RIS.WORLD

ARTICLES CONNEXESPLUS DE L'AUTEUR

DM DIV Amériques

USA – FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease

DM DIV Asie-Pacifique

Australia – Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
DM DIV Europe

Europe – MIR PDF 7.3.1 New MIR form – mandatory as from November 2025

ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.
DM DIV International

International – ISO 10993-23: 2021/Amd.1:2025 – Biological evaluation of medical devices — Part 23: Tests for irritation Amendment 1: Additional in vitro reconstructed human...

DM DIV Europe

UK – Nice recommends first AI medical device for skin cancer diagnosis in the NHS

DM DIV Europe

Europe – EUDAMED user guide : UDI Devices

TEAM-NB : Survey on NBs applications against IVD new regulation
DM DIV Europe

Europe – European Artificial Intelligence Act (Version 2)

TEAM-NB : Survey on NBs applications against IVD new regulation
DM DIV Europe

Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745

DM DIV Europe

UK – Clinical investigations of medical devices – guidance for manufacturers

ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.
DM DIV International

International – ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General...

DM DIV International

International – Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

DM DIV International

International – IMDRF guidance details when regulators should share postmarket surveillance reports

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