mdr Archives

Jun

MDR Annex XVI – Medical or Not?

June 22, 2026Brian PateNews

MDR Annex XVI provides a list of products that are a specific category of items regulated under the EU Medical Device Regulation (MDR) 2017/745 even though they do not have an intended medical purpose. These are products are like medical devices in terms of functioning, risk profile, and application but are used for non-medical applications,...

May

IFU “How To” Website

May 24, 2021Jordan PateNews

New to medical devices and need an orientation of the creation of instructions for use (IFU)? A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV. In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for...

Dec

FDA Voluntary Device Malfunction Summary Reporting

December 26, 2017Alan KusinitzNews

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...

Dec