The Medical Device Regulation 2017/745 (MDR)1 has been out and about for almost four years after its entry into force in May 2017. This new legal framework has had a massive impact on the medical devices sector and, even though the different economic operators, notified bodies (NBs) and competent authorities had an extra year to get ready before it fully replaces the Medical Device Directive 93/42/EEC (MDD)2 (after the date of application was postponed due to the COVID-19 outbreak by means of Regulation (EU) 2020/5613), there are still lots of uncertainties regarding the implementation of several of its articles.
Asphalion’s Medical Devices Experts have developed a white paper which provides an overview of the impact of article 117 MDR will pose on Directive 2001/83/EC.
This White Paper is aimed at clarifying the principal points that should be taken into account by Pharmaceutical Companies with regard to their integral DDCs while preparing the MAA dossiers or maintaining the granted licenses during life-cycle management in Europe.
You can download this white paper here: WHITE PAPER | Impact of MDR on Directive 2001/83/EC