Overview of the Clinical Evaluation for Medical Devices
CE Marking is the entry to selling medical devices in Europe, under the EU Medical Device Regulation (MDR) 2017/745. EU MDR indicates that manufacturers ‘shall plan, conduct and document a clinical evaluation’. The requirements for the clinical evaluation of medical devices are laid down in Article 61 and Annex XIV of the EU MDR.
Why do I need a clinical evaluation?
The Clinical Evaluation Report (CER) is a critical document in MD development and regulation, ensuring your device is safe and effective for patient use and meets its intended purpose effectively.
Let’s walk through what to expect from EU MDR on the CER and tips to prepare.
Key concepts for creating an effective CER
A CER is a comprehensive analysis of pre-market and post-market clinical data relevant to a medical device, including the technical and clinical aspects of the device.
The key concepts that need to be considered when creating a CER are:
How should a CER be structured?
Patient safety is the ultimate goal of any CER for medical devices. To ensure a CER is comprehensive and well organised to demonstrate the safety and efficacy of your device, the following general contents should be considered:
What about Software as a Medical Device?
SaMD is a broad term covering a range of products, from apps assisting in disease diagnosis to AI-based algorithms used in the monitoring of disease. It is crucial to establish if your software is classed as a SaMD.
The requirements of Article 61 and Annex XIV of the EU MDR are still applicable to SaMD, but here are some key points to remember:
When do I update the Clinical Evaluation?
The Clinical Evaluation is an ongoing process that should take place all along the life cycle of the device, even after CE Marking.
The Clinical Evaluation under EU MDR is a critical, evidence driven process, and careful planning and ongoing updates throughout the device lifecycle are essential to maintaining compliance with EU MDR requirements. We have the experience and expertise to efficiently develop your CER to help meet the current EU MDR. Please contact us today to get started, eitherby phone on +441484662575 or via email: info@lfhregulatory.co.uk
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Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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