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11/2025
Deciphering LEEM's new PDDs: the ethical framework for Industry-Patient relations and patient associations
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Medical device law
The entry into force of Regulation 2017/745 on medical devices (MDR) marks the end of the applicability of national provisions...
Pharmaceutical law
The ANSM has just published its report on financial sanctions for 2021, deciphering the issues at stake
Review of the 2 Council of State rulings on the registration of generic groups, for the latest issue of the Gazette
An essential tool in the PV system, the PSMF room has been imposed since 2018 by the French BPPV. A look back at its implementation for EMPS.
Some devices that are CE marked according to one of the MD or AIMD directives can still be marketed after the date of application of the regulation.
Digital & E-health
The CNIL adopted by deliberation n° 2021-118 of 7 October 2021 (JORF 24 October 2021) a new reference framework aiming to "simplify the procedures".
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