European Medical Device Regulatory Law Product Liability

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

Product Liability for Medicines and Medical Devices in the …

https://www.taylorwessing.com/synapse/ti-eu-medical-product-liability.html

Within the European Union, the general product liability laws are based on (i) a strict liability regime (without fault) under the national laws of the member states implementing the EU Product Liability Directive …

Medical Devices Regulation (EU) - Checklist for legal teams

https://www.simmons-simmons.com/en/publications/ck6t8qyyf2efq09073hmrhm0k/medical-device-regulation-eu---checklist-for-legal-teams

Product Liability for Medicines and Medical Devices in the …

https://www.lexology.com/library/detail.aspx?g=4735409d-c3d3-4bac-9446-500a2ef04127

Generally speaking, one can say that while European substantive product liability rules are largely similar to the substantive U.S. laws, the overall litigation risks of …

European medical device regulatory law and product liability

https://pubmed.ncbi.nlm.nih.gov/10658776/

The Medical Devices Directive 93/42/EEC is applied in each EEA State by national Legislation. In the UK, for example, the relevant law is the Medical Devices Regulations …

Ensuring the safety and performance of medical devices

https://eur-lex.europa.eu/EN/legal-content/summary/ensuring-the-safety-and-performance-of-medical-devices.html

Besides medical devices, the regulation also covers certain groups of products which do not have an intended medical purpose. These include coloured …

Medical Devices and Compulsory Insurance in the EU

https://www.biosliceblog.com/2020/02/medical-devices-and-compulsory-insurance-in-the-eu/

The Opinion notes that EU law has not harmonised the issue of insurance against civil liability for the use of medical devices. The current regulatory framework for …

European medical device regulatory law and product liability

https://www.sciencedirect.com/science/article/abs/pii/S019567019990083X

The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative …

Product Liability: Medical Device Manufacturers Pay …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/product-liability/

Product liability plays a major role in legal practice and should not be underestimated by medical device manufacturers and other economic operators such as importers and …

European medical device regulatory law and product liability

https://www.sciencedirect.com/science/article/pii/S019567019990083X

The Medical Devices Directive 93/42/EEC is applied in each EEA State by national Legislation. In the UK, for example, the relevant law is the Medical Devices …