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SINGLE DIGITAL GATEWAY - FRONT OFFICE SPECIFICATIONS
MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
MDCG 2019-14 Explanatory note on MDR codes
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies - August 2019
GROW/E3 - Hackathons - Bucharest - Programme 18-19 May 2019
Machinery Directive 2006/42/EC - Technical sheets for coordination vertical Recommendation for Use sheets (RfUs)
MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746
MDCG 2018-7 Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745
Machinery Directive 2006/42/EC - Technical sheets for coordination horizontal Recommendation for Use sheets (RfUs)
Functional requirements for Copernicus Distribution Service and DIAS
Executive summary of the feasibility study for a dedicated database containing all Union and domestic labelling rules and providing a simple way to identify concrete mandatory labelling requirements per product
Feasibility study for a dedicated database containing all Union and domestic labelling rules and providing a simple way to identify concrete mandatory labelling requirements per product - Final report
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)
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