US FDA Consulting for Medical Device and IVD Manufacturers

ANSWERED ON THIS PAGE:

• Why does third-party FDA consulting makes sense for some medical device companies?
• Which aspects of the FDA premarket review process can be helped by third-party consulting?
• Which types and sizes of medical device firms stand to benefit from using third-party consulting to interact with US regulators?

If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Your CER documents the result of the clinical evaluation of your device. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.

Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements - but Pepgra has the experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER.

Preparing a Clinical Evaluation Report (CER) for medical devices

A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.

You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.

When to update your device CER

The initial report is just the beginning of your CER’s lifecycle. Update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:

• Every year, or...
• When you receive new information from post-market surveillance that could change the current evaluation, or...
• Every 2-5 years if the device is not expected to carry significant risks and is well established.

We can assist with your EU Clinical Evaluation Reports and literature reviews

Pepgra specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory consultants brings depth of clinical experience with a range of medical devices and IVDs. We can:

• Gather and analyze appropriate scientific literature applicable to your device.
• Compile and draft the CER in compliance with EU requirements.
• Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER.
• If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.

Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.