EU IVDR 2022 Changes: An Overview of Regulatory Requirements in 2017/746

Since the introduction of the In Vitro Diagnostic Directive (IVDD 98/79/EC) nearly 20 years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. That’s because under IVDD 98/79/EC, about 80-90% of finished devices are not subject to Notified Body oversight. Starting in May 2022, this laissez faire era will come to an abrupt end. This is a four-part series on the EU IVDR. Download all four parts as […]

European IVDR PDF + Table of Contents for 2017/746

Weighing in at 157 pages and 85,000 words, the new European IVD Regulation requires serious concentration for regulatory professionals. We’ve made this daunting task a little easier by adding a fully linked, easy-to-navigate Table of Contents to the IVDR. Just download the IVDR PDF and save it to your desktop for quick reference. Inside the EU IVDR PDF (2017/746), you’ll find quick links to every Chapter, Article and Annex. If you are new to IVD regulation in Europe (or even if […]