How Much PMS Data Should We Include in Our Clinical Evaluation Reports?

One of our customers recently asked this question, and it’s a good one. Much has been written about the need to maintain clinical evaluation reports (CER) throughout the entire life cycle of devices. There has been far more emphasis on postmarket surveillance (PMS) reporting in recent years, and the result is that clinical evaluation reports for established devices now often include a substantial amount of PMS data. Thus, when medical device regulatory professionals compile required postmarket reports, they rightfully wonder […]

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Futureproofing Your Medical Device QMS for Global UDI Expansion

The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]

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ISO/TR 20416: Best Practices for Medical Device Postmarket Surveillance

How do I define a PMS objective? What postmarket data needs to be collected? How do I analyze it? What’s the connection to other QMS processes such as risk management? As many QA/RA practitioners know all too well, these questions are not well addressed in ISO 13485:2016 and ISO 14971:2019. The goal of this technical report (it’s not a full standard) is to share best practices on how to interpret the general postmarket requirements of the European Medical Device Regulation […]

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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 […]

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