Clinical Evaluation Plan for Software Medical Devices
The clinical evaluation plan is the blueprint for what you are going to do to clinically evaluate your software medical device throughout its development cycle.
This part of the product development journey is important for Clinical and Regulatory milestones
Clinical Evaluation Plan (CEP) in more detail
Since the CEP is the blueprint for your clinical evaluation process, it is important to work through the process thoroughly and systemically to ensure you cover what you are going to do at each stage to meet the regulatory requirements. This process is not just a tick box, but something to build into your company to demonstrate safety and clinical effectiveness throughout the product life cycle.
The Clinical Evaluation process consists of three steps:
1. Valid Clinical Association (Scientific Validity): Is there evidence to suggest the potential for your device’s use case, and what are the state-of-the-art benchmarks?
2. Analytical Validity: Does your device behave correctly in test conditions?
3. Clinical Validity: Does your device behave correctly in the clinical setting? How are you planning to prove this in both the pre- and post-market stages?
These 3 separate steps need to align carefully with your product’s Intended Use. If there’s any misalignment or misunderstanding between these stages, your clinical evaluation may not validate your product as needed.
Best Practices
Align with internationally recognised standards.
There are clear clinical evidence requirements your SaMD has to meet (plus the added benefit of helping you create a safe and effective technology). The level of clinical evidence required for medical device software (MDSW) is set out in the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR) and the soon-to-be-deprecated Medical Devices Directive (MDD). There are helpful guidance standards which outline the best way to align with the regulations. MDCG 2020-1, provides a useful framework to help you determine the level of clinical evidence you require for your device to fulfil these regulatory requirements. MDCG 2020-5 advises on demonstrating equivalence between your device and medical devices that are already on the market and the data pertaining to this. Another useful resource is MEDDEV 2.7/1 rev 4 which provides guidance on a five-stage approach to clinical evaluation for devices intending to be sold within the European Economic Area (EEA).
All the above regulations apply in the EU and UK. If you are submitting in the US then whilst still useful, the IMDRF can also provide more specific guidance with their Clinical Evaluation Guide as well as a specific guide for SaMD.
Case Study
How Hardian solves the problem
Hardian worked closely with Tuune to work out the best high-level strategy to evaluate the platform’s clinical effectiveness. By taking a bespoke approach and considering Tuune’s long-term product strategy, we were able to define a clinical development plan that aligned with commercial and clinical objectives throughout multiple releases of the product.
The team at Hardian can help with aligning your clinical evaluation strategy across multiple jurisdictions, to make sure that your processes for validating your company’s technology are streamlined but still meet the most rigorous standards.
Get in touch
Get in touch to see how Hardian can help you create a solid Clinical Evaluation Plan.