Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
In Short -
The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
1/31/2019
/ Criminal Liability ,
Disclosure Requirements ,
Distributors ,
Emotional Distress Damages ,
EU ,
France ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Standards ,
Supreme Court of France
The Situation: The European Commission ("Commission") has requested that the European Chemicals Agency ("ECHA") investigate the need for an EU-wide restriction on "intentionally added' micro-plastic particles.
The...more
11/29/2018
/ Chemicals ,
Cosmetics ,
ECHA ,
EU ,
European Commission ,
Landfills ,
Manufacturers ,
Member State ,
Nanomaterials ,
Public Consultations ,
Public Health ,
REACH
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more