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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How Much Postmarket Surveillance (PMS) Data Should We Have In Our Clinical Evaluation Reports (CERs)?

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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EU MDR CER and EU IVDR PER for Software:
Understanding MDCG 2020-1

The EU Medical Device Regulation (MDR 2017/745) and EU In Vitro Diagnostic Regulation (IVDR 2017/746) put forward a multitude of challenges, chief among them the process of clinical evaluation. For medical device and IVD companies making products that incorporate software, the question of how much clinical evidence to gather can be perplexing. Rest assured that you are not the only one scratching your head. Many are apprehensive about how Notified Bodies will evaluate clinical evaluation reports (CER) or IVD performance […]

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MDCG 2020-5 Gives Unequivocal Guidance on Medical Device Equivalence Under the EU MDR

If your medical device clinical evaluation relies on a comparison to an “equivalent” device, you may be wondering if your Notified Body would view your analysis as a true “apples to apples” comparison. Although the word “equivalent” seems clear, few words have created more angst in the context of EU Medical Device Regulation (EU MDR). What exactly does “equivalent” mean? Does it mean “exactly the same” or more like “very similar”? The answer depends on whom you ask. But before […]

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