Strategic distribution of medical devices in Europe

by Maria Klaas | Jul 19, 2019 | News

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

Juli 2019 – 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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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!