Useful Tips for Devising a Clinical Development Plan
A Clinical Development Plan is a defined strategy that maps out the expected method that is to be used for collecting relevant evidence and data of a sufficient level and quality for use in evaluating the performance and safety profile of a medical device as part of a Clinical Evaluation. Creating a Clinical Development Plan constitutes part of the CEP (Clinical Evaluation Plan), and can be difficult, as many aspects of the device under evaluation need to be considered. Generally, the risk classification of the device under evaluation determines the level of evidence that the Clinical Development Plan will need to aim to collect and the number of data sources the Clinical Evaluation will need to be considered. Class III devices for example are much more likely to require a Clinical Investigation as part of their Clinical Development Plan than Class I devices, which are afforded greater leniency with regard to the quality and quantity of evidence that needs to be collected as part of the Clinical Evaluation.
Clinical Development Plan: where to start
In writing a Clinical Development Plan, you should ask yourself the following questions with regard to the device that is under evaluation:
- How was our device initially developed? Is the device a major/ minor update to a previous device or is it new to the market? Has the development of the device commenced with pre-market analysis to obtain confidence for safety and efficacy?
- Is my device a high risk classification? Is it eligible for an expert panel review?
- Have we conducted a clinical investigation/ clinical trial on our device? If not, can we provide a rationale for why we haven’t?
- What other clinical evidence is available on our device? Do we hold scientific publications that evaluate our device in its clinical use environment or in a pre-clinical setting?
- What pre-clinical evidence is available? What emphasis will be placed on our pre-clinical evidence in the demonstration of the device’s safety and performance as part of this Clinical Evaluation?
- Have we got much PMCF data or PMS data collected on our device? Do we plan to collect future PMCF data if our device is able to be successfully placed/ successfully remains on the market?
- Will we be claiming equivalence with another device? If so, what clinical evidence is available for this device should our equivalence evaluation be successful?
- Has the device been on the market under the MDD? Would we be able to claim the device was ’Well-Established’ using MDCG 2020-6 [MDCG 2020-6: Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC] to reduce the requirement for the level of clinical evidence needed?
- Can we provide a rationale as to why the planned sources of clinical evidence and data are anticipated to provide a sufficient level and quality of clinical evidence and data?
By using this list of questions, the Clinical Development Plan will present the strategy for the collection of a sufficient level of clinical evidence and data that will ultimately allow your device to be evaluated against the requirements of the scoped regulation.
Ultimately, medical devices manufacturers should consider putting themselves in the experienced hands of an external regulatory expert for devising an effective and appropriate clinical development plan, saving their internal staff both time and stress!
Contact us at firstname.lastname@example.org to find out how we can help you with your clinical development plan and more!