Why IVDs Will Be Urgently Jostling For Notified Body Attention
Executive Summary
With the EU's Medical Device Regulation and IVD Regulation having been drafted, adopted and now taking effect at the same time, the EU IVD sector often seems to be lagging behind its bigger medical device brother. Now it must fight to the front of the queue to get help from increasingly pressured notified bodies to survive through the transition process.
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.