Blog
RSS FeedPosted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...
Posted by Michael Wonder on 01 Mar 2022
Regulation on EMA’s extended mandate becomes applicable
1 March 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes ...
Posted by Michael Wonder on 26 May 2021
Medical device regulation comes into application
26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...
Posted by Michael Wonder on 21 Apr 2020
Why countries can’t meet the demand for gear against COVID-19
19 April 2020 - A host of efforts are under way to unblock bottlenecks. ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...
Posted by Michael Wonder on 28 Feb 2019
First guidance on new rules for certain medical devices
28 February 2019 - EMA has published today the first of a series of guidance documents to help applicants prepare ...
Posted by Michael Wonder on 10 Aug 2018
The need for transparency of clinical evidence for medical devices in Europe
11 August 2018 - To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for ...
Posted by Michael Wonder on 08 Jun 2016
EU agrees tighter standards for medical devices
1 June 2016 - The European Union has agreed major changes to its 20 year old regulatory framework for medical devices. ...