Good Distribution Practices for Medical Devices Requirements of New Regulations MDR 745/2017 and IVDR 746/2017
Περιεχόμενα Εκπαιδευτικού Προγράμματος
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, (application date: 26 May 2021)
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (application date: 26 May 2022)
Approved MDCG Directives (relating to Marketing, as well as references to relevant MEDDEVs, Consensus statements and Informative documents / Factsheets
Substitution (in force as applicable in cases of product categories in a transitional period and other relevant references):
Directive 93/42/EEC on medical devices: Harmonization of National Legislation: DY8d/G.P.oik130648/Government Gazette 2198B/02-10-2009
Directive 90/385/EEC on Active Implantable Medical Devices: Harmonization of National Legislation: DY8d/G.P.oik130644/Government Gazette 2197B/02-10-2009
Directive 98/79/EC – 27/10/98 (FOR IN VITRO DIAGNOSTIC MEDICAL PRODUCTS): Harmonization: DY8d/oik3607/892/Government Gazette 1060B’/10-8-01
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Good Distribution Practices for Medical Devices Requirements of New Regulations MDR 745/2017 and IVDR 746/2017
