Klaas consulting

Market Entry and Development Medical Devices

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Meet us virtually 16-19 November 2020

Latest News

Market Barriers in Germany for Medical Devices
The global market for medical technology companies
Effizienzsteigerung des Vertriebs von Medizinprodukten
Medizinprodukte Markt in Frankreich
Apotheken und Parapharmazien in Frankreich

Latest Insights

Maetrics publishes 10 actions for UK conformity assessment for download
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
after the French company GMED 3EC International a.s. from Brastislava was appointed as the 17th Notified Body for the MDR; they all are listed in the Nando database
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
TÜV Süd was recognized by the ZLG as a notified body for in-vitro diagnostics according to the new IVDR
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!

Downloads

Vertrieb von Medizinprodukten nach Frankreich (Artikel MTD Dialog 4/2020)
Distribution of Medical Devices to France (pdf)
Efficiency increase of the strategic distribution of medical devices in Europe for SMEs (pdf)
Viel Optimierungspotenzial beim strategischen MT-Marketing (Artikel MTD Dialog 10/2016)
Great Potential for Improvements Remain in Strategic Marketing in German Medical Technology (PDF)
Neue Impulse für Hersteller durch Handelsprodukte (Artikel MTD Dialog 11/2016)
New impulses for the sale of Medical Devices (PDF)

Medical Devices Markets

where we offer Distribution Consultancy Services

Austria
Belgium
Czech Republic
Denmark
Finland
France
Germany
Great Britain
Greece
Ireland
Italy
Luxembourg
Netherlands
Norway
Poland
Scotland
Spain
Sweden
Switzerland

Address

Klaas consulting
Weissdornweg 26
50997 Koeln
Germany

Contact

Tel: +49(0)2233 923749
Fax: +49(0)2233 923748

contact@klaasconsulting.com
www.klaasconsulting.com

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