Medical device manufacturers who want to sell their devices on the EU market must draft and maintain a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745). The clinical evaluation report is a critical step for CE marking of medical devices and during the lifetime of the device - it must be updated continuously. While the EU MDR does describe clinical evaluations for medical devices, extensive guidance can be found in MEDDEV 2.7 rev. 4, issued in 2016.
MEDDEV 2.7 rev. 4 Clinical evaluation: a guide for manufacturers and notified bodies under directive 93/42/EEC and 90/385/EEC was issued as guidance to clinical evaluations under the old medical device regulations. Even though it was tailored to the old regulations, it still provides high-level guidance to clinical evaluations under the MDR.
MEDDEV: Guidance documents drafted by various interested parties, such as competent authorities, commission services, the medical device industry, and others. MEDDEV documents are not legally binding.
MEDDEV 2.7 rev. 4 promotes a common approach to clinical evaluation for medical devices, not in vitro diagnostics (IVDs).
Clinical evaluation is mandatory for all medical devices under the MDR, independent of their risk classification.
Clinical evaluation: collecting, appraising, and analyzing clinical data pertaining to a medical device to evaluate the risk-benefit profile of the device and confirm compliance with the General Safety and Performance Requirements for safety and performance when the device is used as intended.
Clinical data: safety and/or performance data generated from the clinical use of a medical device. Clinical data can be sourced from clinical investigations, scientific literature, and reports on the clinical experience of the device and similar devices.
Clinical evaluations should be tailored to the device under evaluation and its risk classification. A clinical evaluation for a Class I or Class II device will not contain the same degree of information and clinical data as a clinical evaluation for a Class III device.
Clinical evaluation is a continuous process that must be performed throughout the lifetime of your medical device.
The first clinical evaluation is performed during the development of a medical device to identify any data that must be generated once the device is put on the market. This is also where equivalence to other devices is initially justified.
Clinical evaluation is mandatory for the conformity assessment that leads to CE marking. This is where conformity to the General Safety and Performance Requirements is demonstrated and any aspects that must be addressed systematically, such as post-market clinical follow-up studies, are addressed.
Your clinical evaluation must be updated continuously throughout the lifetime of your device. The exact timelines are different between risk classes: you must update your clinical evaluation annually for new or high-risk devices and every two to five years for lower-risk devices. During the updates to your clinical evaluation, you must collect and analyze information that demonstrates that the clinical behavior of your device in the market is satisfactory, i.e., that the risk-benefit profile remains acceptable.
Any medical device clinical evaluation is based on pre-clinical and clinical data relevant to the intended purpose of the device.
There are generally five stages to a clinical evaluation:
The clinical evaluation report is where you document the clinical evaluation and its output. The amount of information needed for the clinical evaluation report differs according to risk classification and the technology of the target device. New technology should include overviews of the developmental process and development cycles and where clinical data is generated, which is not required for technologies that are already well-established.
The clinical evaluation report should include enough information to be read and understood as a stand-alone document by third parties who are not intimately familiar with the target device. Furthermore, claims and statements should always be well-documented, substantiated, and justified.
The clinical evaluation report is reviewed by the notified body during conformity assessment.
A suggested format for the clinical evaluation report is provided in Appendix A9 of MEDDEV 2.7 rev. 4.