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Market entry and devolpment medical devices
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

  • 20. notified body according to MDR – Eurofins Expert Services Oy; they all are listed in the 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
  • the EU Council decided on 22 April 2020 that the EU MDR will be postponed until 26 May 2021 – read here!

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