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Market entry and devolpment medical devices
Market Segmentation in Germany

Market Segmentation in Germany

Market Segmentation in Germany as a Key Success Factor for Market Entry July 2021 - Market Segmentation in Germany - According to the Federal Ministry of Health, there are about 400,000 different...

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MRA between Switzerland and the EU

MRA between Switzerland and the EU

MRA: Switzerland is preparing a worst-case-szenario April 2021 - MRA between Switzerland and the EU has to be updated. The new MDR has implications for the market introduction of medical devices in...

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Medical Device market in France

Medical Device market in France

With 67 million inhabitants, France is the second largest market in Europe after Germany. And this also applies to the Medical Device sector. Therefore, medical device manufacturers from all over the world would like to place their products here as well.

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Medical Devices Regulations (MDR)

Medical Devices Regulations (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.

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Strategic distribution of medical devices in Europe

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?

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Meet us in Duesseldorf or virtually 15-18 Nov. 21

Medica 2021 Duesseldorf

Latest Insights

  • 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
  • 22 Notified Bodies are now accredited. Currently (August 21) there are 4 in Italy, 2 in Finland, 3 in the Netherlands and 6 in Germany; in addition, one each in Slovakia, Hungary, Norway, France, Sweden, Ireland and Croatia. Nando database
  • 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
  • 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.
  • In-vitro-diagsnostics must be re-evaluated according to the new IVDR by 26 May 2022.
  • In future, the IVDR will also cover high-risk products that are manufactured and used in a single health facility, as well as genetic screening and tests for predisposing patients
  • The European Council postpones the application of EUDAMED by two years until May 2022

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