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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6 Areas That Need Your Attention Before Your Next EU MDR Notified Body Audit

The European Medical Device Regulation (2017/745) went into effect on May 26, 2021 and there’s still a lot to focus on. If you have legacy devices that will require EU MDR registration between now and 2024, there are some things that you need to focus on to ensure your product remains on the European market. 1 – Get your existing clinical evaluation reports in shape. MEDDEV 2.7/1 rev 4 expanded the requirements for clinical data and the MDR reinforces this […]

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How “Equivalent” Does a Medical Device Need to Be Under the New EU MDR and MEDDEV 2.7/1 rev 4?

Involved in updating medical device Clinical Evaluation Reports? Check out these tips from the pros. While there are several new requirements related to CER content contained in MEDDEV 2.7/1 rev 4 and the MDR, one of the more perplexing issues concerns the issue of “equivalency.” Companies selling devices that complied with the old Medical Devices Directive 93/42/EEC long used existing scientific literature and equivalent device statements in their CERs. The purpose of doing so was to avoid having to conduct […]

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