Covid-19 worth knowing (Germany)

by Klaas | May 18, 2021 | uncategorized

• 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.
• Recommendations of the GKV-Spitzenverband to ensure the supply of medical aids during the spread of the coronavirus SARS-CoV2, valid until 31 March 2021
• 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)
• EU response to the coronavirus – strategic rescEU medical stockpile for ventilators, PPE products, vaccines et al hosted by 6 EU member states: Denmark, Germany, Greece, Hungary, Romania, Sweden
• 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 April 2021
• 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 Sept. 2020)
• 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
• GHX offers a free supplier list for healthcare providers – for face and eye protection, respiratory protection mask, surgical masks, hygiene supplies, disinfectants, disposable garments, cannulas, respiratory equipment, disposable gloves, protective covers for couches

Healthcare statistics of selected EU countries.

by Klaas | May 21, 2018 | uncategorized

The medical devices markets of Germany, United Kingdom, France, Italy and Spain are the largest in Europe. Some of the best-known medical device manufacturers are based in these G5 countries and some major players from around the world have operations here. Nevertheless, small-to mid-sized medical device companies make up the majority of the industry.

Health Expenditure Profile
European Countries
Source: WHO 2020