European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers - Couverture souple

O'Brien, Mr Des

 
9781092813518: European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers
Couverture souple
ISBN 10 : 1092813519 ISBN 13 : 9781092813518
Editeur : Independently published, 2019

Synopsis

The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
Independently published
Date d'édition
2019
Langue
anglais
ISBN 10 
1092813519
ISBN 13 
9781092813518
Reliure
Broché
Nombre de pages
127
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
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