MDR 745/2017 keynote - I'm a student and I'm writing a thesis

[Ramor]

Hi, I'm a student and I'm writing a thesis on the evolution of regulamentation of medical devices. If anyone could send me info, notes or somethings else, expecially on the transition I would be really greatful

 

[rob73]

Hi Ramor
There is plenty of good information out in the interbubs, take a look at
Global Medical Device Consulting – Regulatory, Quality, Clinical | Emergo
Standards, Training, Testing, Assessment and Certification | BSI Group
This is a pretty good flow chart showing the regulatory process for medical devices
www.medtecheurope.org/regulatory/mdr_flowchart

BTW i am not affiliated with any of these, just found them helpful.

 

[pkost]

which country are you studying in? If you are in Europe it may be worth contacting your local competent authority and speaking to the policy people

 

[Yasuaki]

If you want to know the history of the lawmaking process of MDR, using the Advanced search of EUR-Lex (the following link) may be useful, especially "Procedure" tag.

<http://eur-lex.europa.eu/advanced-search-form.html>

 

[Ramor]

Thank you all