In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020.
-
May 22, 2020 Medical Devices, Regulatory Affairs -
August 30, 2019 Medical Devices, Regulatory AffairsThe European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market.
-
November 7, 2017 Regulatory Labeling, Health Authority UpdatesDo you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.