Which EU Notified Bodies Are “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates

UPDATED May 20, 2022 Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions. YES! EU Notified […]

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Supplementing Your Medical Device PMS Efforts with Online Data

Blogs. Social media. Online forums. Product reviews. While postmarket clinical follow-up (PMCF) studies, user surveys, clinical registry studies, electronic health records, and insurance claims data are all important sources of proactive data, most complaints will never cross your desk. Instead, users will often take to online forums and social media to voice their concerns. These potential sources of postmarket surveillance (PMS) data are probably not high on your priority list. After all, trying to extract relevant and actionable PMS data […]

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The Medical Device Single Audit Program (MDSAP): Your Questions Answered

Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019. At Oriel STAT A MATRIX we get many questions about MDSAP, so we have compiled a list of the most common ones. Questions and responses are grouped into the following categories. Who Needs […]

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Ready, Set, Score! Understanding the MDSAP Grading System

In this game, a high score is not the goal! The MDSAP grading system (MDSAP AU P0037) was established to address inconsistencies from traditional audit grading approaches like “major finding,” “minor finding,” and “opportunity for improvement” by establishing objective criteria to characterize the significance of findings that can be easily shared among participating Regulatory Authorities (RAs). How It Works During an MDSAP Audit, nonconformities are assigned a grade/score of 1 to 5 that is calculated using a two-step grading system. […]

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