European Court Opinion Raises Questions About Notified Body Liability
Executive Summary
An opinion from an advocate general at the EU Court of Justice could have an impact on whether TÜV Rheinland is found liable and might have to pay damages in the PIP breast implant case, raising broader issues about liability insurance for notified bodies.
You may also be interested in...
Brexit: The UK MHRA's View Of The Elephant In The Room
UK preparations for a Brexit deal with the EU are not following the smooth path that the UK government would like, as more and more complications emerge. The executive bodies charged with translating Brexit seamlessly into UK policy and law can only watch and wait, but the MHRA, for one, has a strong feel for what is best for UK health care stakeholders.
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.
EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives
The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.