Erik Vollebregt explains how medical device manufacturers entering into agreements with subcontractors can safeguard their rights and avoid exposure to risks and liabilities under European Union law....
Cécile Derycke and Agnès Roman-Amat discuss the implications of a Civil Supreme Court decision on “defects” and “causal relationships”. The French Civil Supreme Court (Cour de Cassation) has upheld...
A US Senate committee has been warned that there could be “regulatory chaos” if proposed legislation that seeks to overturn the pre-emption authority of the US Food and Drug Administration over...
When the US Congress enacted the Medical Devices Amendments to the Federal Food, Drug, and Cosmetic Act in 1976, it recognised that medical devices were different from other products subject to the...
US president Barack Obama wants a review of all federal regulations issued in the last ten years that intend to pre-empt individual state laws, to ascertain whether these were issued with sufficient...
The role of the authorised representative in the European Union has taken on a deeper significance as a result of the changes brought about by Directive 2007/47/EC, the medical device amending...
A key area for the development of nanotechnology is in medicines and medical devices. The application of nanotechnology to health, sometimes referred to as “nanomedicine”, raises high expectations...
A recent verdict by Germany’s Federal High Court of Justice on the extent to which medical device companies are under obligation to remove defective products from circulation marks a milestone in...
Legislation has been reintroduced in the US House of Representatives to reverse an “erroneous” Supreme Court ruling that bars injured patients from seeking compensation from manufacturers of faulty...
When was the last time you cringed after reading an email sent by someone in your organisation as you imagined how a prosecutor or plaintiff's lawyer could use it to imply sinister behaviour? Maybe...
There have been developments in a closely watched product liability lawsuit in which Health Canada , rather than the manufacturer of the products involved, has been accused of negligence for...
