Medical Device eLabeling & eIFU Requirements Under the EU MDR

The last time you purchased a product on Amazon, I am sure you eagerly opened the box and immediately sat down to thoroughly study the accompanying instructions for use (IFU), right? All joking aside, the instructions for use that ride along with medical devices are far from an afterthought. In fact, they are pretty darn important for patient and user safety and a key focus of your risk management efforts. Increasingly, manufacturers are opting to distribute IFUs electronically on websites, […]

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 […]

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