Essential IVD Document Delays Add To Concerns Over 2022 Deadline
Executive Summary
The IVD Regulation is due to fully apply on 26 May 2022, but the infrastructure for manufacturers to demonstrate compliance and for notified bodies to perform their audits according to the new rules keeps being delayed.
You may also be interested in...
Lobbying For A One-Year Delay To The EU IVDR: Solution Or Forlorn Hope?
The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be ready in time. But industry faces a dilemma: will lobbying and pining hopes on a delay be the best use of its resources?
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.