It is commonly known that COVID-19 IVD tests may be CE marked under annex III of the IVD Directive without the involvement of a Notified Body. To nonetheless increase supervision,… Read More
Tag: COVID-19
Update from the European Commission for protective equipment in the COVID-19 crisis
The European Commission has updated its Q&A document on conformity assessment procedures for protective equipment like face masks, gloves, coveralls, etc. The corresponding document can be downloaded here. Furthermore, the… Read More
COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
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
European Commission guidance on surgical masks
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
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