What the notified body assesses
A notified body assessing a medical device's clinical evaluation focuses on clinical evidence of the device's safety and performance, with a level of scrutiny set by the device's risk, classification and novelty. It reads the clinical evaluation report against the manufacturer's other interlinked documents and builds its own assessment report from them, and a writer who knows what the body looks for can better write and present the report for that assessment.
What the notified body focuses on
The Medical Device Regulation forces notified bodies to focus more on solid information about a device's safety and performance under its normal intended use. That information shall be based on clinical data providing sufficient clinical evidence to support compliance with the essential requirements. The level of scrutiny depends on the product's risk, classification and novelty.
The documents assessed alongside the report
Apart from the clinical evaluation report, notified bodies scrutinise risk management documentation; the post-market surveillance plan and report; the periodic safety update report; the post-market clinical follow-up plan and report; and the summary of safety and clinical performance. All these documents must be interlinked and constantly updated.
Notified bodies are expected to write a clinical evaluation assessment report of their own. It is based on the clinical evaluation report, including its methodology, the authors' qualifications, the frequency of updates, the demonstration of equivalence and the conclusion on the clinical benefit-risk analysis. It is also based on the device description and intended purpose, the preclinical evaluation data, the risk management documentation, the clinical investigation plans, results and justifications, the post-market surveillance and post-market clinical follow-up plans and their justifications, and conformance to the relevant essential requirements.
Writing the report for assessment
A writer who understands what notified bodies are looking for can better write and present a clinical evaluation report for assessment.
In the view of a notified body's head in 2018, the bars have been raised, and professional medical writers preparing high-quality medical device documentation need to understand the product and its description, impact and relevant clinical data; apply up-to-date regulations; and write for the target audience, including notified bodies, competent authorities and expert panels.