The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply feasibility.
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. Considering the current global scenario and the shortage of devices and other medicinal products, the EC deemed it necessary to focus on ensuring the adequate supply of devices, as usual, instead of stressing more on the transition of the EU MDR.
The 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. The MDR and IVDR aim to ensure that products are effective, safe, as well as freely and fairly traded throughout the region.
Do 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.