Find all the regulations related to medical devices, pharmaceutical products and wines and spirits here. Classification by medical device class and geographical area helps to simplify your search. If you are looking for more information on a specific regulation, please to contact us.
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Implantable medical devices, the implant card
Europe
AIMD
The Regulation (EU) 2017/745 introduced an additional obligation for implantable medical devices, the implant card. It achieves two specific objectives: to increase transparency and to ensure better access to information about the IMD. IMD manufacturers will have to indicate all the required information on an implant card that will be delivered with the device. In…
Eudamed, the registration of economic actors
Europe
Medical Devices Information
Updated version 2.9 – October, 2022 The registration module of the economic actors is an electronic system which allows to register the companies as: Manufacturer, Authorized representative, Importer, System/Procedure pack producers. The registration creates a unique registration number that will allow economic operators to submit all necessary information in order to be easily identifiable throughout…
Implementation of EU Regulation 2021/2117
Europe
Wines & Spirits
8 December 2023 On this date the changes to labelling rules for wines and aromatised wines will become effective. Producers will then have to provide the list of ingredients and nutritional information for their products. For example, the new directive stipulates that producers must indicate that a wine contains sulphites if quantities exceed 10 mg/L….
European medical device regulation – 2017/745
Europe
Medical Devices Information
In order to reform legislation on medical devices, the European Commission has adopted two regulations, which have been in force since May 2021. The first, Regulation (EU) 2017/745, pertains to medical devices. The second, more specific Regulation (EU) 2017/746 targets in vitro diagnostic medical devices. The European regulation of medical devices can be confusing to…