UK medtech investigation: regulators, industry and experts react
This article was originally published in RAJ Devices
Executive Summary
The May 16 Channel 4 Dispatches programme on the medtech industry and its regulation – The Truth About Going Under the Knife – was emotive, and full of blood, gunge and gore. The investigation, a collaboration with the BMJ, highlighted how beneficial devices, particularly implantables, can be, but also showed how frightening it can be for patients and their families when devices fail because of inadequate regulation and/or lack of compliance or unethical behaviour.
You may also be interested in...
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.
Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?
Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission.