The European Commission’s “State of play of joint Implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR”, which… Read More
Tag: European Commission
Relocation of the European Commission website on medical devices
In summer 2019, mdi Europa has reported that the European Commission has restructured its website on medical devices. Since then, manufacturers could retrieve valuable information about EU regulatory requirements under… Read More
European Commission’s device standardisation request rejected
The formal standardisation request from the European Commission to the European standards bodies will get essential standards work to support compliance with Regulation (EU) 2017/745 on medical devices (MDR). The… Read More
Updated timetable for Eudamed
On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database. According to the Commission,… Read More
Surgical and FFP masks in the COVID-19 crisis
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
MDR Postponed by One Year!
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
European Commission gives details of how to prevent COVID-19 test failures
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
MDR Postponement – Handle with Care!
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
Guidance on MD and PPE in times of COVID-19 and local provisions
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
Latest MDCG Preparedness Plan and MDR Delay
The European Commission proposed a delay of the MDR and suggested to postpone the date of application for one year due to the current COVID-19 crisis. The Joint Implementation/Preparedness Plan… Read More
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
The European Commission proposed to exempt certain medical devices and personal protective equipment (PPE) urgently required in the current COVID-19 crisis from regular CE marking requirements. Germany and the UK… Read More
News on EUDAMED
From different sources we have heard that the introduction of EUDAMED will be delayed – probably for two years. In the meantime, this has been confirmed on the European Commission’s… Read More
European Commission Website on Regulations MDR / IVDR Restructured
The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices… Read More