Which EU Notified Bodies Are “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates

UPDATED May 7, 2022 Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions. YES! EU Notified […]

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New EU IVDR Compliance Deadlines – Everything You Wanted to Know…and Then Some

The European Commission – after catching heat from Notified Bodies and industry players alike – finally came to the conclusion that perhaps forcing a May 2022 compliance deadline on thousands of ill-prepared in vitro diagnostic (IVD) manufacturers was not going to end well. As such, the recent decision by the commission to create a rolling action related to the IVDR date of application for many classes of devices was an 11th-hour mea culpa that was painfully obvious to IVD manufacturers […]

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Complying with EU IVDR Postmarket Surveillance (PMS) Requirements

Once the IVDR takes effect, roughly 85% of all IVDs will be subject to Notified Body oversight. As such, manufacturers will be expected to compile detailed technical documentation prior to obtaining CE Marking certification or placing their device on the EU market. A critical piece of that documentation includes your plans and procedures for postmarket surveillance (PMS) – a fancy name for ensuring the ongoing safety and efficacy of your device. Despite the name and regardless of device risk, PMS […]

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EU IVDR Compliance for Makers of Laboratory-Developed Tests (LDT) and In-House IVD Tests (IH-IVDs)

When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests (LDTs or IH-IVDs, which stands for in-house in vitro diagnostics) have had it pretty good…along with most other IVD manufacturers. That is about to end on May 26, 2022. While the EU In Vitro Diagnostic Directive (IVDD 98/79/EC) exempted makers of so-called in-house tests (aka LDTs), the new In Vitro Diagnostic Regulation (IVDR 2017/746 download) does not carve out many exemptions for these tests. Still, without a […]

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