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Market entry and development medical devices
MRA between Switzerland and the EU

MRA between Switzerland and the EU

Apr 19, 2021 |

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

Apr 3, 2020 |

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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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!

Boost your business in Europe – Find your European consultancy for medical devices.

The European medical devices market is the second largest in the world, preceded by the U.S. and followed by Japan. According to a report by the International Trade Administration (US Department of Commerce), the European medical devices market is expected to continue its expansion and grow by 9% every year.

The total European medical devices markets are estimated at 95 Bill. EUR. The leading EU markets are Germany, France, Italy, United Kingdom and Spain.

The European Union embraces a unique patchwork of markets, systems, regulations and mentalities, but also presents challenges and possibilities for the exporters of medical devices. A suitable consultancy firm with expertise in the medical devices sector is the key to your success

You can have brilliant ideas, if you can´t get them across, your ideas won´t bring you anywhere.

Lee Lacoca

Efficient clinic targeting with the QB-Analyzer

Online tool for quick and easy determination of market potential in the German hospital market. Suitable for marketing analysis and sales control.
•    analysis of data with diagrams and corresponding diagrams
•    select ICD-Codes and OPS-Procedures and visualize them on the map
•    group regional data into clusters
•    export the results of the analyzes and illustrate them in reports
With current data of the year 2019.

Find your way in the health market jungle – Klaas consulting – your medical device consultancy

According to your requirements, we offer you a tailor-made service package to enable your smooth and efficient entry onto the market in European countries

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