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
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
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.
Total population
Total expenditure on health
Total expenditure on health
2017
per capita (Intl.$,2017)
% of GDP (2017)
Austria
8,772,865
4,940
10,4
Belgium
11,351,727
4,507
10.3
Czech Republic
10,578,820
1,476
7.2
Denmark
5,748,769
5,800
10.1
Finland
5,523,231
4,206
9.2
France
66,804,120
4,380
11.3
Germany
82,521,656
5,033
11.2
Greece
10,768,193
1,517
8.0
Ireland
4,784,383
4,977
7.2
Italy
60,589,444
2,840
8,2
Luxembourg
590,667
5,783
5,5
Netherlands
17,081,508
4,911
10.1
Norway
5,258,317
7,936
10,4
Poland
37,972,964
0,907
6.5
Spain
46,528,024
2,506
8,9
Sweden
9,995,153
5,905
11.0
Switzerland
8,419,550
9,956
12,3
United Kingdom
65,844,144
3,859
9.6
Health Expenditure Profile European Countries Source: WHO 2020
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Latest Insights
Medical device manufacturers can apply to the Joint Federal Committee (G-BA) for the NUB and receive advice on the procedure. Rules of Procedure of the G-BA.
Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
30 Notified Bodies are now accredited. Currently (May 2022) there are 7 in Italy, 2 in Finland, 3 in the Netherlands and 8 in Germany; in addition, one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Ireland, Poland and Croatia. Nando database; see also MTD
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
28 Notified Bodies are now accredited. Currently (April 2022) there are 7 in Italy, 2 in Finland, 3 in the Netherlands and 7 in Germany; in addition, one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Ireland and Croatia. Nando database
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
28 Notified Bodies are now accredited. Currently (April 2022) there are 7 in Italy, 2 in Finland, 3 in the Netherlands and 7 in Germany; in addition, one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Ireland and Croatia. Nando database
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.
