- in the first quarter of 2023, all restrictions were lifted until further notice
- Corona self-tests listed with the BfArM
- Corona self-tests, tested by the Paul Ehrlich Institute
- Exemption from customs duties and VAT on imports of medical devices and protective equipment until 31 December 2021 in the EU
- As of 12.4.21, the BfArM has granted special approvals to 35 antigen tests for self-testing by non-professionals.
- Stiftung Warentest tested 10 FFP2 masks. The test winner was the Aura 9320+ mask from 3M.
- EU Commission has created the possibility for Notified Bodies to carry out virtual audits in individual cases. Notice.
- from 1.10.2020 only FFP2 and FFP3 masks with a CE mark may be sold in Europe (according to Dekra)
- the Federal Ministry of Economics has launched a matching platform for protective equipment (PPE) (MAPS)
- to recognise a good FFP2 mask
- new general ruling on hand disinfectants issued by the Federal Institute for Occupational Safety and Health (BAuA)
- Portal with PPE providers in Berlin and Brandenburg
- German register for outpatient intensive care
- New guideline for the funding of projects on the „Prevention and treatment of epidemic infections with innovative medical technology“ from the German Federal Ministry of Education and Research, published on 3 August 2020
- EU Commission extends customs and VAT exemption on the import of medical devices and protective equipment (PPE) from third countries until the end of June 2022
- The European Commission demands preferential certification of coronary medical devices by Notified Bodies and publishes a new „Covi-19 list of essential medical devices (MDs and IVDs)“
- Information from BfArM on the use of mouth-nose covers, medical face masks and particle-filtering half masks – intended use, classification as medical device or protective equipment, the testing and certification and protective effect
- Application portal for the fast track procedure of Medical Apps of the BfArM. More info.
- The German Federal Institute for Drugs and Medical Devices (BfArM) has updated the instructions for manufacturers, importers and distributors for the special approval of medical mouth and nose protection (MNS) and filtrating half masks (FFP2 and FFP3). According to BfArM, there is currently no longer a supply bottleneck for these products in the current SARS-CoV-2 pandemic situation. Therefore, the special approval was adjusted accordingly. Read more (status March 2022)
- The Federal Ministry of Health (BMG) published a Sars-CoV-2 Drug Regulation on April 21, 2020. Also affected are specifications for medical devices in the context of the corona epidemic.
- Europe Acts initiated Europe vs Covid-19, a free, Europe-wide platform for companies and hospitals offering or requesting medical products
