European Commission’s MCGD New Guidance on Classification of Medical Devices
Updated Guidance for e-Submissions for CEP applications
MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
MDCG 2021-14 - Explanatory note on IVDR codes - European Commission
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe
PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release
Open Consultation for EU common standard on electronic product information- EMA
EU IDMP Implementation Guide - version 2.0