Digitalized Clinical Evaluation Process
Along with risk management, clinical evaluation is one of the most important lifecycle processes for medical devices. To demonstrate clinical safety and performance for market access in Europe, clinical data must be collected, appraised, and analyzed in sufficient quantity and quality. Not only for the initial market approval, but also as part of regular post-market surveillance activities during the marketing & sales phase. In addition to a systematic and transparent approach, the connection and dependency of clinical evaluation information with other processes is a particular challenge – inconsistencies can quickly creep in.
avaClinical was introduced in 2019 as an innovative product that allows you to carry out and document a systematic clinical evaluation digitally for the first time. The proof for sufficient clinical evidence is presented in a clear and comprehensible manner, making it easier for the authors of clinical evaluation plans and reports to prepare them in compliance with regulatory requirements. Notified bodies can find required contents according to MDCG 2020-13 more quickly, which supports the creation of the Clinical Evaluation Assessment Report (CEAR).
The product includes best practice templates e.g. for the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) based on the MDR, Article 61 and Annex XIV as well as MEDDEV 2.7/1 Rev. 4 and relevant MDCG guidelines. The templates can also be customized to your needs.
In the CEP you can plan for each subject which data is supposed to be used for detection. Subjects can be linked to information from other processes to visualize dependencies, e.g. for product development, risk management, or marketing materials.
The template for the Summary of Safety and Clinical Performance (SSCP) reflects the structure of the MDCG 2019-9 guideline and clearly addresses individual questions of the clinical evaluation.
Single “questions” in the CEP related to the clinical safety, clinical performance, benefits or marketing claims – which require clinical evidence – are documented in form of Clinical Evaluation Subjects. Also each identified data set is documented individually and linked to the Clinical Evaluation Subject. That allows in the CER an automated creation of overview tables with a clear representation of data used as evidence for a single Clinical Evaluation Subject. With this approach you always maintain a clear overview, no matter how many data records you use.
The benefit-risk assessment in the CER can be easily reused in the Risk Management Report – this way, inconsistencies do not stand a chance.
New Features
Since 2024, avaClinical has been expanded with extended state of the art templates and functions as well as claim management features and optimized literature review:
- State of the Art
SOTA information can now be systematically collected and reviewed, including the derivation of acceptance criteria for medical device performance and safety parameters which can be used as input for the CEP as well as product requirements and risk management planning. - Claim Management
A major hassle for medical device manufacturers is transparently tracking and maintaining marketing claims and related evidence for a single claim. It is not a one-off process to validate claims for a product launch, for example, since claims may need to be adjusted or even removed if post-market clinical follow-up activities result in a change to the product’s benefit and risk profile. avaClinical now allows tracking of claims and a trace to clinical and non-clinical evidence information throughout the entire product lifecycle. - Literature Review
The literature review process has also been optimizing allowing integrated IMDRF adverse event coding directly within avaClinical during literature evaluation.
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