medical device manufacturers Archives

Pharmacies and Parapharmacies in France

by Maria Klaas | Mar 6, 2020 | News

Drastic changes in the pharmacy and parapharmcy sector in France

photo: Klaas consulting
pharmacy in Paris

March 2020, by Maria Klaas Drastic changes for pharmacies and parapharmacies in France expected in the near future.

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GTAI has created a special page on sanctions and the consequences of the war in Ukraine.
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
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Revised guidance on "Designation of a Swiss authorised representative under the new MepV" of 29 January 2021, addressed to Swiss distributors and importers.
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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.
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The new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 has entered into force. It must be implemented for products... with higher risk by May 2025, ...with lower risk class C by May 2016, ...with lower risk classes B and A by May 2027
The European Council postpones the application of EUDAMED by two years until May 2022