Medical Device Claims and Clinical Evaluation Under the EU MDR
By Miriam Sharif-Murray, M.S., Nerac Analyst
Originally Published February 13, 2023
The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance. They tell the end user what to expect of the device and declare how it is intended to be used. Because of this, the formulation of claims should start early and be managed thoughtfully throughout the development of the device.
Device claims are a part of the advertising and promotion of a product which, in the European Union, are regulated by MDR 201/745, along with several EU directives, and the legislations of the individual EU Member States. Article 7 of the MDR outlines the requirements for medical device claims and lays out three categories of claims for which a manufacturer may not “mislead the user” and for which they must provide substantiation. These include claims regarding a device’s intended purpose, those pertaining to its safety, and claims that speak to the clinical performance of the device. Specifically, it states:
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:
- ascribing functions and properties to the device which the device does not have;
- creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
- failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
- suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
The substantiation or disproval of claims is to be carried out as part of the conformity assessment of a device and are required to be done by way of a clinical evaluation, which the MDR defines as “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.” The clinical evaluation must be “thorough and objective, and take into account both favourable and unfavourable data.” According to MEDDEV 2.7/1 Revision 4, the documentation of claims that pertain to a device’s clinical performance or clinical safety should occur early in the clinical evaluation process and be analyzed and compared to available clinical data throughout.
The results of the clinical evaluation and the clinical evidence on which they are based must be captured in a Clinical Evaluation Report (CER), which is part of the technical documentation that a notified body reviews to assess the conformity of a device to medical device regulations. Briefly, MEDDEV 2.7/1 Revision 4 states that the following items should be addressed in the CER:
- Physical and chemical description
- Device classification
- Applicable standards
- The technologies used
- Labeling, including instructions for use
- Clinical literature review
- Clinical evaluation
- How the device achieves its intended purpose
- Claims made in available promotional materials
- Claims on clinical performance and clinical safety foreseen by the manufacturer
- Post market activities
After a product is CE marked, the clinical evaluation and, subsequently, the CER must be updated with information gathered during post market clinical follow up activities. During this phase of the process, a determination should be made about whether the benefit/risk profile is still favorable, if existing claims are still substantiable, and if any new claims introduced about the device are justified. All stages of the clinical evaluation and the completion of the clinical evaluation report must be carried out by a suitably qualified individual or team.
How Can Nerac Help?
Nerac’s Medical Device team has experience assisting manufacturers in developing MDR 201/745 compliant Clinical Evaluation Reports. Our analysts are experts in identifying and analyzing clinical data from available literature as it relates to state of the art and safety and performance for medical devices, including in vitro diagnostics.
Contact us here to learn more.