Crafting an Effective Clinical Evaluation Plan
The MEDDEV 2.7.1 (Rev 4) introduced the requirement of a Clinical Evaluation Plan (CEP) and the Medical Device Regulation (MDR 2017/745) gave more details on what this new and critical document should contain (particularly in Annex XIV, Part A).
The scope of the full clinical evaluation is stated in the CEP and includes, at the very least, the following:
- The general safety and performance requirements
- as supported by relevant clinical data
- The intended purpose of the device
- The intended target groups
- with indications and contraindications
- The intended clinical benefits
- with a justification for specific, relevant clinical outcome parameters
- The methods that are to be used for examining clinical safety
- with a reference to how any residual risks and side-effects are to be determined
- A description of the “state of the art” in medicine
- in order to demonstrate the acceptability of the risk-benefit ratio
- Information that supports the conformity of the device
This CEP is central and ties into many other essential documents such as the Post-Market Clinical Follow-Up (PMCF) which is itself a part of the Post-Market Surveillance (PMS) plan, and the Clinical Evaluation Report (CER). This CER, in turn, drives the PMS report, the Periodic Safety Update Report (PSUR), and the Summary of Safety and Clinical Performance.
With such a comprehensive coverage of the background and developmental aims of the medical device and the inter-relatedness and inter-connectivity of the plans and later reports it is therefore important to invest significant time, energy, and resources to craft a high quality Clinical Evaluation Plan in the first place and for each of its subsequent updates.
Medical Device Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) Click to read [Online] (Accessed: 02 Oct 2019).
MEDDEV 2.7/1 revision 4: European Commission. Clinical Evaluation: Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. Click to read [PDF] (Accessed: 02 Oct 2019).
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