This regulatory topic has become increasingly pertinent, ahead of the countdown to the EU's new medical device and in-vitro diagnostic rules, set to take effect in May 2020 and 2022, respectively. In a PharmaTimes article, consultant Cliodhna McDonough considers why the new medical device regulations in Europe present a huge challenge to manufacturers, but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.

To read the article, click here.