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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IVD Manufacturer Clinical Evidence Needed for IVDR Performance Evaluation Reports. Where to Begin?

In vitro diagnostics (IVDs) are a tiny fraction of overall healthcare costs, but they play an outsized role in patient diagnosis and decisions. While medical devices can cause physical harm to a patient or user through direct impact, IVDs can also inflict indirect harm through improper diagnosis or patient care caused by incorrect results. Regulators in Europe realized that a much wider product offering of IVDs needed to be held to the same standard as medical devices with regard to […]

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The Importance of Properly Grouping IVD Registrations Under the EU IVDR

The European In Vitro Diagnostic Regulation (IVDR) will take hold soon enough. When that happens, 80-90% of all IVDs will require CE certification by a Notified Body, up significantly from what was required under the In Vitro Diagnostics Directive (IVDD) (i.e., 10-20%). That enormous expansion has caused widespread heartburn in the industry, especially among those unfamiliar with strict new IVDR requirements. Classification of IVD Devices Under the IVDR The In Vitro Diagnostic Regulation (EU 2017/746) groups products according to risk: […]

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