EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8: What Has Changed?

Important: Since the new EU MDR will become mandatory for all postmarket activities beginning May 26, 2021, medical device manufacturers need to ensure that their procedures are updated and employees responsible for vigilance reporting are trained on the change in reporting timeline. What About MEDDEV 2.12-1 Rev 8? MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting, even with […]

» Read more

Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

It’s 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All of a sudden you are jolted back to reality by an email about a serious incident at a French hospital involving your company’s heart monitor. Details are sketchy and somewhat lost in translation. It’s now 9:00 p.m. at your office in Europe. They are closed for the weekend and you can’t get more details. Can it wait until Monday? If you’ve been in your […]

» Read more

6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year. 1 – Internal audits and gap assessments The new European medical device […]

» Read more

Medical Device Postmarket Surveillance (PMS): Building a Process

This is the final article in a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: Medical Device Complaint Handling: Understanding the Basics  Part 2: Is That Medical Device Incident Reportable? Part 3: To What Extent Should You Investigate That Medical Device Complaint? Part 4: This post According FDA, postmarket surveillance is the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.” […]

» Read more
1 2 3