Market Barriers to the introduction of medical devices in Germany. What could these be and how can they be overcome?

Latest Insights

• (June 22) studies published by the German Society for Biomedical Engineering in the VDE (VDE DGBMT)
  1. "Use of sensors in combination with implants and application systems".
  2. "Approval of medical implants according to the European Medical Device Regulation (MDR)".
• (June 22) the EU Commission published a document in June 22 for the IVDR: "Harmonised administrative practices and alternative technical solutions until EUDAMED is fully operational".
• (June 22) The Interest Group for Medical Devices in Germany (IG-NB) has published 2 guides on the topics of
  1. artificial intelligence (AI)
  2. cybersecurity
• 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.
• (April 22) Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
• GTAI has created a special page on sanctions and the consequences of the war in Ukraine.
• Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
• (May 22) 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.
• New web portal for the list of medical aids according to §139 SGB V of the GKV-Spitzenverband: for reference and online application
• Revised guidance on "Designation of a Swiss authorised representative under the new MepV" of 29 January 2021, addressed to Swiss distributors and importers.
• Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
• (August 22) 32 Notified Bodies are now accredited. Currently there are 8 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, Spain (July 22), 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
• BfArM included the first “apps on prescription” in the new directory for digital health applications (DiGA) in early October 2020
• 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
• EU-implementation regulation for the reprocessing of disposable products, valid from 26 May 2021
• FDA increases medical device registration fees from October 2020
• The European Commission published the new “Clinical evaluation assessment report template” of the Medical Devices Coordination Group (MDCG) on 17 July 2020
• In-vitro-diagsnostics must be re-evaluated according to the new IVDR by 26 May 2022.
• The new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 has entered into force. It must be implemented for products... with higher risk by May 2025, ...with lower risk class C by May 2026, ...with lower risk classes B and A by May 2027
• 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.
• New web portal for the list of medical aids according to §139 SGB V of the GKV-Spitzenverband: for reference and online application
• Revised guidance on "Designation of a Swiss authorised representative under the new MepV" of 29 January 2021, addressed to Swiss distributors and importers.
• 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
• EU-implementation regulation for the reprocessing of disposable products, valid from 26 May 2021
• In-vitro-diagsnostics must be re-evaluated according to the new IVDR by 26 May 2022.
• The new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 has entered into force. It must be implemented for products... with higher risk by May 2025, ...with lower risk class C by May 2016, ...with lower risk classes B and A by May 2027
• The European Council postpones the application of EUDAMED by two years until May 2022