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.
28.09.2018 – The MDR (Medical Devices Regulation) will cause great changes in the world of medical technology. The MDR has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive).
Meet us at Arab Health (January 27-30 November 2025) – ask for an appointment!
Latest Insights
(Dec 24) Number of hospital treatments in Germany increased by 2.4% to 17.2 million in 2023. Nevertheless, not yet at the pre-corona level of 2019 of 19.4 million (according to the Federal Statistical Office). Read more about the QB Analyser. It can tell you in which hospitals the treatments take place.
(Dec 24) India: according to an E&A analysis, the medtech market is expected to grow from USD 12 billion in 2023/24 to USD 50 billion by 2030. India will remain heavily dependent on imports. In 2023/24, approx. 85% was sourced from abroad. Germany accounted for 11%. Market entry India: read here.
(Aug 24) 48 Notified Bodies in 18 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland, Poland and Czech Republic and one each in Belgium, Denmark, Hungary, Lithuania, Norway, Slovakia, Slovenia, Spain, Sweden,Turkey, Ireland, Croatia and Cyprus. Nando database. GMED SAS from France, Paris is no longer a Notified Body
(Aug 24) Roland Berger Hospital Study 2024 in Germany. Larger hospitals expect a positive development in the coming years. Smaller hospitals are rather pessimistic about the future. According to the study, mergers could be a solution. (in German)
(July 24) New MDCG guideline on the clinical evaluation of orphan devices
(July 24) According to the current Hospital Rating Report 2024, 10% of hospitals are in the "red zone" with an increased risk of insolvency.
(June 24) According to the spring survey of the Hospital Index of the German Hospital Institute (DKI) (in German) 61% of German general hospitals rate their current economic situation as poor (40%) or very poor (21%). The reason for this is the forthcoming Hospital Care Improvement Act (KHVVG)
(Jan 24) TÜV Süd BABT Unlimited is an approved UK Aproved Body (UKAB) for Part III of the UK Medical Devices Regulations 2002 for Active Implantable Medical Devices (AIMD). Manufacturers can now obtain both UKCA and CE certification from TÜV Süd at the lysame time.
(Jan 24) Expansion of the AOP catalogue by the GKV-Spitzenverband
(Jan 24) Eudamed: the mandatory use of the UDI/Medical Devices Registration and Certificates/Notified Bodies modules has been postponed from Q1 2026 to Q2 2029
(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.
(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
(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.
(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 aleaflet 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)
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
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.
