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

Latest Insights

• (Aug 23) Swissdamed (Swiss Database on Medical): ACT module, available from the beginning of 2024 for the registration of companies; registration of products via UDI module, available from summer 2024.
• (Aug 23) 39 Notified Bodies in 16 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland and Poland and one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Spain, Ireland, Croatia, Cyprus and Czech Republic . Nando database
• (Aug 23) TÜV Süd, Germany also UK Approved Body (UKAB) for medical devices. Current list of UKAB according to the UK Government's Medicines and Healthcare products Regulatory Agency.
• (May 23) The Medical Device Regulation Group (MDCG) published guidance on 12 May 2023 on the significant changes to the transitional provision under Article 120 of the MDR
• (May 23) Great Britain decides to extend the deadline for CE marking of medical devices according to MDR. From July 2025, the new legal framework is to apply
• (March 23) Transition periods for the approval of medical devices in Europe now legally extended.
  • May 2026: Custom-made medical devices (Class III).
  • December 2027: Higher-risk medical devices (non-exempt Class IIb implants and Class III medical devices)
  • December 2028: Low-risk medical devices (Class IIa, Ir, Im, Is).
• (March 23) Current information from BfArM on the German Medical Devices Information Database System (DMDIS), "Clinical Investigations/Performance Evaluations" module for all user groups (as of Jan. 30, 2023)
• (Jan 23) Manufacturers of digital care applications (DiPA) can now apply directly to the BfArM for inclusion of their application in the DiPA directory via a digital application portal
• (Jan 23) Since 1.1.2023, condoms have been available free of charge in pharmacies in France for people between 18 and 25 years of age. Since 1 year also contraceptives, e.g. IUDs and the birth control pill.
• (Dec 22) According to. MHRA (Medicines & Healthcare products Regulatory Agency), the United Kingdom will continue to recognise the CE mark for medical devices until 30 June 2024. Previously, 30.6.2023 was planned.
• (Dec 22) According to the Roland Berger MedTech@Hospital study, about two-thirds of German hospitals expect to close the 2022 financial year in the red. More than half also plan to invest less in medical technology.
• (Nov 22) According to the Roland Berger study "Global MedTech-How to succeed in uncertain times", the medical technology industry is struggling with high energy costs, rising inflation and supply chain problems. Solutions are offered by digitalisation, more benefit-based billing models and the shift towards personalised medicine.
• (Nov 22) Facts&Figures 2022 from MedTech Europe, the European trade association for the medical technology industry
• (Nov 22) New MDCG document on requirements for Notified Bodies - in the context of the MDR as well as IVDR
• (Nov 22) Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
• (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
• 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
• Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
• 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
• 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
• The European Council postpones the application of EUDAMED by two years until May 2022