2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations

Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion and harmonize the guidance with the EU MDR. They include: Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019 (formerly […]

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What’s the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We’re Glad You Asked…

In case you need any convincing that many forms of clinical data are a priority for European regulators and Notified Bodies, consider these numbers. The EU Medical Devices Directive (93/42/EEC) mentions the word clinical 81 times. The MDD’s replacement, the EU Medical Device Regulation (MDR 2017/745), mentions it 677 times. Yes, I know what you’re thinking – the MDR is 3x longer than the MDD – but simple math instantly tells you that the days of scant clinical evaluation reports […]

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Writing Your EU MDR Clinical Evaluation Report and When to Update It

You’ve done a lot of work to get this far. Writing a medical device clinical evaluation report (CER) is the culmination of a monumental effort to conduct literature searches, find/review literature, and/or conduct original clinical investigations. Data must be sourced, appraised, analyzed, and then summarized into your CER. This final process – writing the CER itself – is commonly referred to as Stage 4. This is the final post in a 4-part series on Clinical Evaluation Reports. In our first […]

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Analyzing Your Medical Device Clinical Datasets and Drawing Conclusions

Anyone who has ever researched and compiled an entire European clinical evaluation report knows that the devil is in the details. Finding appropriate clinical data is not necessarily the most challenging aspect of the process – it’s the appraisal and analysis of that data that causes regulatory heartburn.   This is the third post in a 4-part series on Clinical Evaluation Reports. In our first post we talked about creating a solid clinical evaluation plan, in the second post we […]

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