The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more
Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more
12/2/2024
/ Artificial Intelligence ,
Corporate Counsel ,
EU ,
Manufacturers ,
New Regulations ,
Product Defects ,
Regulatory Reform ,
Regulatory Requirements ,
Software ,
Statute of Limitations ,
Strict Product Liability
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 EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
11/13/2023
/ Burden of Proof ,
Damages ,
Distributors ,
EU ,
European Commission ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Proposed Regulation ,
Regulatory Agenda ,
Retail Market ,
UK
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
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