Back in April, 2020, the European Commission has committed itself to set up a database of CE marked COVID-19 IVD tests. The Commission has now published a link under which… Read More
mdi Europa has been contacted frequently throughout the COVID-19 crisis regarding regulatory requirements for surgical masks in Europe under Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) on medical devices.… Read More
The German Federal Institute for Drugs and Medical Devices (BfArM) has specified on its website the provisions for this special route, which follows Recommendation (EU) 2020/403 from March 13. The article… Read More
What has been proposed by the European Commission and confirmed by the European Parliament has been signed off by the European Council. As a consequence, the delay of Regulation (EU)… Read More
The European Commission has published a derogatory report on the level of evidence available for COVID-19 tests – RNA, antigen and antibody tests – arriving on the market. It explains… Read More
The proposal for a one-year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step… Read More
The European Commission has continued to work on guidance for manufacturers and other economic operators of medical devices and personal protective equipment (PPE) to provide answers on specific questions that… Read More
