Take Timely Steps To Alleviate Upcoming IVDR Compliance Woes
Non-Negotiable: Compliance With EU Diagnostics Regulation Must be Planned In
Executive Summary
The transition periods for complying with the EU’s In Vitro diagnostics medical devices regulation might have been extended, but that does not change the scale of the compliance task at hand for manufacturers, says digital labeling provider Kallik.
You may also be interested in...
UK LifeSci Funding Boost – Medtech Research And Regulation To Benefit
Rebranded Health Innovation Networks, Biobanks and clinical trials get share of £650m UK funding earmarked to support research, manufacturing, skills development and access to diagnosis and treatment.
UK Pro-Innovation Report Offers Promise For Medtech With MHRA/NICE Alignment
Report to government underlines need for faster, parallel evaluation of medtech and healthtech innovation and recommends bigger role for MHRA alongside work done by approved bodies on UKCA file processing.
News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests
This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.