IVDR-Compliant Documentation?

Your regulatory team is über-organized and has been maintaining duplicate sets of technical documentation for your legacy devices, in compliance with the old MDD 93/42/EEC and IVDD 98/79/EC and the new MDR 2017/745 and IVDR 2017/746. You’re doing this because even though your device has a valid CE Marking certificate that expires between 2023 and 2025, the MDR and IVDR are now the law of the land and you need to manage two sets of documents to maintain compliance with […]

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

UPDATED August 5, 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 […]

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 […]

Preparing for a Notified Body Medical Device Clinical Audit

Public speaking. Root canals. Buying a used car. Being audited. Which do you dread most? Yes, there are unicorns out there who actually enjoy audits, but most medical device regulatory professionals endure them as part of the job. While preparing for an audit is less than fun, going through an audit for which you were unprepared elevates “unfun” to a whole new level. You can only hide under your desk (or remain off camera) for so long. Of course, you […]

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