For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
3/11/2025
/ Certification Requirements ,
Data Protection ,
EU ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Popular ,
Regulatory Requirements
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
4/23/2024
/ Clinical Trials ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
European Parliament ,
Marketing Authorization Application ,
Member State ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Proposed Legislation ,
Regulatory Reform ,
Risk Assessment
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more