Under the medical device directives, clinical data generated by a CE marked device and published in the scientific literature, which meets certain clinical evaluation-related criteria, can be used to support the safety and/or performance of a non-CE marked device, if both devices have been demonstrated to be equivalent.
The manner in which equivalence should be determined in not provided by the directives, but it is described in detail in “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC” (MEDDEV 2.7/1 Rev 4). The guidance explains that a determination of equivalency should be based on the clinical, technical and biological characteristics of the device in question and the potentially equivalent device. The Medical Devices Regulation (MDR; EU 2017/745) has adopted the approach described in the guidance for determining equivalence; however, there are some differences between the guidance and the MDR, which will need to be addressed once operation under the MDR is initiated.
The use of clinical data from CE marked equivalent devices is an important means used by manufacturers of non-CE marked devices in meeting EU clinical data requirements. In recent years, however, the demonstration of equivalency has become increasingly difficult. That is, Notified Bodies are beginning to refuse equivalency rationales more often than in past years.
This means that manufacturers may be faced with the need to conduct a clinical study before a CE mark can be achieved under the MDR, or to maintain a CE mark on a device that is being transitioned from the MDD. It is particularly frustrating to face this difficulty when a device is based on well-established technology and evidence that the device is safety and performs as intended can be provided by non-clinical testing, or if the device has been on the market for many years and not associated with any unacceptable clinical safety or performance problems.
DLC can help you to:
Determine equivalence between your non-CE marked device and one or more potentially equivalent devices in accordance with EU requirements and expectations
Where needed, develop a rationale for equivalence, which can be provided to a Notified Body
Correctly interpret the new requirements included in the MDR regarding equivalence, which have been widely misinterpreted
DLC has the knowledge and experience to assist you in the development of effective medical device, IVD and combination product regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.