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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Writing Your EU CER and How Often 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 […]

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Creating an EU CER Literature Review Protocol and Reviewing Medical Device Clinical Data

Once you have created a robust clinical evaluation plan for your medical device(s), it’s time to get busy figuring out what data you need, drafting a protocol, and then taking stock of that data. This is considered Stages 1 and 2 of the CER process and the specifics can be found in MEDDEV 2.7/1 rev. 4, as shown below.   This is the second post in a 4-part series on Clinical Evaluation Reports. We talked about creating a clinical evaluation […]

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Does Your Medical Device CER Meet EU MDR Requirements? Creating a Solid Clinical Evaluation Process

Medical device regulatory professionals have been grappling with tighter requirements for clinical data to support clinical evidence since MEDDEV 2.7/1 Rev. 4 was released in mid-2016. Now that the European Medical Device Regulation (2017/745) is nearing implementation, clinical evaluation reports (CERs) have taken on new urgency. Regardless of whether you are making updates to existing CERs or building one for a product launch, you want to make sure that you don’t experience any nasty surprises during your Notified Body audit […]

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