The new Medical Devices Regulations (MDR) – what you need to know!
photo: iStock CE mark according to MDR
The new Medical Devices Regulations (MDR) and the Active Implantable Medical Devices Directive (AIMDD) were published in May 2017. Its transitional period will end on 26 May 2020. From that date the MDR will apply fully.
picture: IStock Digitization of Medical Healthcare
August 2019 – Transforming the MedTech Industry – why is that the future?
According to a commissioned study of the United Nations, the world population will increase to 10 billion by 2050. 2 out of 5 people will be over 60 years old and 434 million over 80.
Efficiency increase of the strategic distribution of medical devices in Europe for SMEs
Juli 2019 – Many medical device companies aim to sell their products on European markets. Their own budget bottlenecks allow only limited market opportunities. What are the reasons and what considerations should SMEs make to increase the efficiency of the strategic distribution of their medical devices?
Germany’s Medical Technology Industry Still No. 1 in Europe
24.06.2019 – In 2015, EUR 32.39 billion was generated with medical devices in Germany. Thus Germany’s Medical Technology is clearly No. 1 with 34% of the total European sales of EUR 95 billion.
QB-Analyzer: Your online tool for the targeted analysis of the German hospital market
Marketing and Sales Tool
The QB-Analyzer analyzes and digitizes “annually” all data of the quality reports of German hospitals. Therefore, it is interactive and web-based.
As a result, ideal for identifying market potential and efficiently managing sales. In other words, it is an online tool for the targeted analysis of the German hospital market.
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.