The European IVDR Requirements – What You Should Be Doing Now to Prepare

This is our last blog post in a four-part series on the IVDR. You can read the first post detailing IVDD to IVDR changes, the the second post on technical documentation or the third post on conformity assessment and PMS requirements. Or, make it easy on yourself and download the entire series in one easy-to-read, shareable PDF.

While 2022 seems light years away, there are some really important reasons to take the IVDR seriously and start planning early…like now.

Here are some important things to consider.

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IVDR Conformity Assessment, Postmarket Surveillance, and Vigilance Requirements

This is our third blog post in a four-part series on the IVDR. You can start with our first post detailing IVDD to IVDR changes, or the second post on technical documentation. Or even better download an easy-to-read, shareable PDF containing all four posts.

 buccal cotton swab and test tube ready to collect DNA from the cells.

The EU’s new In Vitro Diagnostic Regulation (2017/746) (IVDR) places a significant new regulatory burden on IVD manufacturers.

Not only will 80-90% of all manufacturers be subject to ongoing Notified Body scrutiny, they will also be required to produce reams of premarket technical data in order to gain CE Marking under the IVDR.…

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IVDR Technical Documentation Needed to Support CE Marking Certification in Europe

This is our second blog post in a four-part series on the IVDR. You can start with our first post detailing IVDD to IVDR changes, or download an easy-to-read shareable PDF containing all four posts.

laboratory technician holding a blood tube test

The May 2022 implementation of the In Vitro Diagnostic Regulation (IVDR – EU 2017/746) is a long way off…or so it may seem.

An estimated 80-90% of all IVDs sold in Europe will be subject to Notified Body approval under the IVDR, up from a scant 10-20% under the IVDD.

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

This is the first blog post in a four-part series on the IVDR. Our second post focuses on technical documentation; our third post on conformity assessment and PMS; and the final post offers advice on what you can be doing now to prepare. We’ve combined all four posts into one easy-to-read, shareable PDF. Download it here.

In Vitro Diagnostic Device

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.…

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