Friday, July 12, 2024, the EU published the new EU Artificial Intelligence Regulation, which is first EU AI Regulation worldwide setting requirements concerning safety and free movement of goods and services using AI...more
7/23/2024
/ Artificial Intelligence ,
Biometric Information ,
Documentation ,
Enforcement ,
EU ,
European Parliament ,
Goods or Services ,
Information Governance ,
Machine Learning ,
Medical Devices ,
Recordkeeping Requirements ,
Regulatory Requirements ,
Risk Management ,
Technology Sector
Earlier this year, the European Chemicals Agency (ECHA) published a proposal for a ban on the production, use and placing on the market (including import) of at least 10,000 per- and polyfluoroalkyl substances (PFAS)....more
Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain...more
On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The proposal introduces a longer...more
EU Regulation on Artificial Intelligence -
On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more
The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more
In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more
On May 5, 2017 the European Union legislator published Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - the EU-Medical Devices Regulations (MDRs) in the...more
Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more