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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
Study on “Development of enforcement indicators for REACH and CLP” - Final Report
CLP Regulation - Study on the harmonisation of the information to be submitted to Poison Centres, according to article 45 (4) of the Regulation (EC) No 1272/2008
Instructions - Access to CARACAL papers publicly available in CircaBC - REACH - CLP
WORKING DOCUMENT on the main text and Annex I of the CLP Regulation (EC) No 1272/2008 consolidated version with Regulation (EC) No 487/2013 (4th ATP to CLP)
Manual on borderline and classification in the community regulatory framework for medical devices
Review of the functioning of the CPV codes/system
Chemicals - Poison centres - Harmonisation of Information for Poison Centres - Review according to Article 45(4) of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
Chemicals - Commission review for the harmonisation of information relating to emergency health response (Art. 45 CLP Poison Centres)
Guidance document - In vitro diagnostic medical devices - Borderline and Classification issues. A guide for manufacturers and notified bodies - MEDDEV 2.14/1 rev.2
Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand alone software - MEDDEV 2.1/6
Guidance document - Classification of Medical Devices - MEDDEV 2.4/1 rev.9
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