IVD 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 a large role in patient diagnosis and decisions that greatly impact patient care. 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 […]

Will Your Team Be Ready for a (Live and In-Person) FDA Medical Device Inspection?

COVID-19 significantly curtailed FDA’s ability to conduct surveillance inspections of medical device manufacturers. Most manufacturers have not had an FDA inspector show up at their facility since at least March 2020. However, on July 1, 2021, FDA resumed on-site inspection operations, although it remains to be seen how quickly they’ll get up to speed. There is little doubt that COVID-19 made it more challenging to maintain a quality management system compliant with the FDA Quality System Regulation (QSR). Most non-manufacturing […]

When Will FDA Resume Medical Device Inspections?

Remember FDA inspections? Yes, we know you’ve missed them, and chances are extremely high that’s because an FDA inspector has not darkened your door since early 2020, likely longer. While virtual meetings are the new normal for many business professionals, it’s pretty clear that FDA has begun to transition to live, onsite inspections of domestic manufacturers. But before they can ramp up to full normal inspection operations… …The FDA Has to Dig Itself Out of a Hole As you probably […]

The Importance of Properly Grouping IVD Registrations Under the EU IVDR

The European In Vitro Diagnostic Regulation (IVDR) takes hold in May 2022. 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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