+49(0)2233 923749 contact@klaasconsulting.com

Be informed

market entry and development medical devices

Downloads

Market Barriers to the introduction of medical devices in Germany

 PDF

Vertrieb von Medizinprodukten nach Frankreich

Efficiency increase of the strategic distribution of medical devices in Europe for SMEs

pdf

Great Potential for Improvements Remain in Strategic Marketing in German Medical Technology

PDF

New impulses for the sale of Medical Devices

PDF

Marktbarrieren gekonnt umschiffen

Distribution of Medical Devices to France

pdf

Viel Optimierungspotenzial beim strategischen MT-Marketing

Neue Impulse für Hersteller durch Handelsprodukte

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!

Get In Touch

Data Protection

contact@klaasconsulting.com