Where should I start? See a brief summary below for tips on how to perform a successful clinical evaluation
What is a clinical evaluation?
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. Performing a clinical evaluation is a requirement of the EU MDR 2017/745 (EU MDR) – it is one of the critical documents required to obtain a CE mark for placing your device on the market. It’s first performed during the conformity assessment process leading to the marketing of a medical device, and then repeated periodically as new clinical safety and performance information about the device is obtained during its use. The conclusions of a clinical evaluations may result in changes needing to be made to documents such as the risk assessment, product claims, and post market surveillance plans and reports. See Annex XIV of the EU MDR 2017/745 for details on specific requirements regarding clinical evaluation plan (CEP) and clinical evaluation report (CER) contents.
Here’s a brief guide to what should be considered when performing a clinical evaluation for the EU MDR:
- Understanding the EU MDR requirements: It is crucial to familiarise yourself with the requirements outlined in the EU MDR regarding clinical evaluations. These requirements are essential both for ensuring the safety and performance of medical devices and a successful application for CE marking.
- Plan ahead: All good reports start with a good gap analysis and a thorough plan. Carry out a gap analysis and, with the intended use and patient population in mind, start by identifying what existing documentation is available (such as clinical studies, verification & validation activities, or published literature) to support the safety and performance requirements of your device.
LFH’s top tip: Make sure to take into account that there may be additional requirements on performance for your type of medical device – remember to check for requirements in standards or guidance to make sure you’re able to meet these requirements and show that your device constitutes the state-of-the-art-in medicine.
- Literature review: A requirement of a clinical evaluation includes identifying published literature on your device, similar (and equivalent) devices to assess and compare performance and safety (don’t forget to conduct searches to also identify the state-of-the-art in medicine). It’s important to conduct these literature reviews thoroughly to ensure all relevant data is captured, both favourable and unfavourable. For guidance on how to carry out a literature review refer to the MEDDEV 2.7.1/4 for some great tips.
LFH’s top tip: It’s important to clearly document your literature search plan – if you deviate it from it, make sure to document this in your CER.
- Clinical data collection: Collect clinical data specific to your device. This may involve conducting clinical investigations, observational studies, or analysing real-world data from post-market-surveillance activities. This data is a fantastic source of untapped information that can highlight the safety of your device.
- Data Analysis & Evaluation: Analyse the collected data to assess the safety and performance of the device. Evaluate factors such as the clinical outcomes, adverse events, and patient/user satisfaction.
- Risk Assessment: Ensure that you have a risk management file that is up to date with ISO 14971:2019. As part of your clinical evaluation report, an evaluator would expect to see a discussion of current risks, and whether or not they are acceptable with reference to the benefit-risk of the device. Perform a thorough risk assessment to identify and mitigate any potential risks associated with the device, including off-label use. Consider factors such as biological, chemical, and mechanical risks, as well as usability issues. Make sure you take into account risks that may have been identified through your post market surveillance and literature searching activities.
LFH’s top tip: Look at risks that you may have identified for similar devices, are these applicable to your device and have they been considered for evaluation in your risk assessment?
- Clinical Evaluation Report (CER): Compile the findings of the clinical evaluation into a comprehensive CER. The CER should include a summary of the clinical data, analysis of the device’s safety and performance, and conclusions regarding its clinical-benefit-risk ratio.
- Expert review: Consider seeking input from clinical experts or regulatory consultants to ensure the accuracy and validity of your clinical evaluation findings. Consultants collaborate with notified and approved bodies to help successfully bring medical devices to the market and have great experience in ensuring that CER are compliant.
- Regulatory submission: Submit the CER as part of your regulatory submission to obtain or maintain CE marking for your medical devices. Ensure compliance with MDR requirements and any applicable guidance documents.
LFH’s top tip: Check for inconsistencies between your CER and Technical Documents (e.g. ensure the Intended Use Statement and your Instructions for Use are aligned).
- Post market surveillance: Continuously monitor the safety and performance of the device through post-market surveillance activities. Update the CER as new data becomes available and incorporate any necessary changes to ensure ongoing compliance with regulatory requirements.
Remember that a clinical evaluation should assess both favourable and unfavourable data. A thorough and well documented clinical evaluation is not only crucial for demonstrating the safety and performance to ensure that they’re safe for use, but also in obtaining CE marking to the EU MDR.
Whether you need help with preparing clinical evaluation documentation, reviewing technical documentation, or performing a gap analysis, our team of consultants can provide medical writing or consultancy support to help get your medical device onto the market. Contact us today, either by phone on +441484662575 or via email at info@lfhregulatory.co.uk.
