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Evaluation of the EU drug precursors regulations
The CND Nomenclature - background and general principles
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES.
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES. Version 1.19 of April 2018
Poison Centre study - Feasibility study on interlinked databases, format and basic application to facilitate exchange of information between Poison Centres, according to Article 45 (4) of EC Regulation No 1272/2008 (CLP Regulation)
Guidance document on grey zone problem: Is a specific product covered by the Toy Safety Directive 2009/48/EC or not
Manual on Borderline and Classification in the Community regulatory framework for medical Devices
List of Members Borderline and Classification Medical Devices Expert Group
RPS Pilot Plan adopted by the IMDRF Management Committee
official request for expression of interest from Notified Bodies
EU's classification matrices for MDD
EU's classification matrices for IVD
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