webinar
IVD
Ask the experts: Will you be ready for the new IVD regulation?
The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies…
blog
IVD
IVD Directive to IVD Regulation (EU 2017/746) Transition – 8 Months Remaining
IVD Regulation Postponement Today 14th October 2021 the European Commission has issued a Question and Answers press release on the…
webinar
IVD
Changes and Impacts of the New EU IVD Regulatory Requirements with CDx Specifics
The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These…
blog
IVD
New regulations for IVD Manufacturers when developing new devices
New requirements of the European regulations: demonstration of clinical evidence To improve the health and safety of patients and users,…
publication
IVD
The Proposed EU IVD Regulation and its Impact on Companion Diagnostic Development
Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news. Sylvie Le Glédic,…
