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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Your Notified Body may ask to see your strategy for regulatory compliance during your next audit. Do you have one?

As European regulatory compliance becomes more complicated many medical device and IVD manufacturers have had their Notified Bodies ask them for a written “strategy for regulatory compliance” document. Given a choice, most regulatory professionals would prefer to not experience the same “deer in the headlights” moment these manufacturers must have had when asked for this by their auditor. The need for a regulatory strategy stems from Article 10(9a) of the EU Medical Device Regulation (MDR) or Article 10(8a) of the […]

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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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