1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Recommendation for a book about the EU regulations

Discussion in 'EU Medical Device Regulations' started by Anna Lee, Jun 21, 2016.

  1. Anna Lee

    Anna Lee New Member

    Joined:
    Jun 21, 2016
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Hi,

    I am looking for a recommendation for a book about the EU regulations i.e. a book that gives an overview of the medical device regulations in the EU etc. Would anyone have some suggestions?

    AL.
     
  2. Marcus Emne

    Marcus Emne New Member

    Joined:
    Apr 8, 2021
    Messages:
    1
    Likes Received:
    1
    Trophy Points:
    1
    Old thread but unanswered. Regulations changes too often and what is in print becomes obsolete too fast, hence no books. If there was one, I would not rely on it. To get a baseline overview you would need to gather documentations per market (local country) and EU. There might be local differences in some aspects and sometimes people forget that Norway, UK, Switzerland are outside EU.

    Secondly you would need to monitor changes and upcoming changes per local market and EU. On top of that I strongly recommend that you also monitor what experts writes about the regulations, it is not completely black / white after all...
     
    Last edited by a moderator: Apr 8, 2021
    Atul Khandekar likes this.
  3. Pubrica healthcare

    Pubrica healthcare New Member

    Joined:
    Apr 20, 2021
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Medical devices terminology broadly covers any instrument, implement, apparatus, in-vitro reagent, machine, software or an article used in human beings health care. WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, European Union Medical Device Regulation of 2017 are available for free download.Fundamentals of EU Regulatory Affairs spotlights the important transformation of the healthcare product regulatory sector in the European Union (EU). European Medical Device Regulation for MedTech and Medical Device Manufacturers is also a reference book.
     
    Last edited by a moderator: May 24, 2021

Share This Page