MDR regulation

Claiming Equivalency Under the EU Medical Device Regulation

Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstrating clinical performance of your medical device, i.e. demonstrating that your device performs as intended and has benefit to patients. Clinical data in support of performance can come from many sources including: clinical literature, trials, usability, post-market clinical follow-up (PMCF), the state-of-the-art, and/or from “equivalent” devices.

Using clinical justifications based on device equivalence has been standard practice in the EU for quite some time. This is to avoid having to conduct redundant pre- or post-market clinical studies to prove safety and performance. Compared to the MDD, the MDR specifies stricter requirements for comparative evaluations used to claim equivalency. The best strategy for MDR regulation compliance would be one that does not rely on an equivalence argument; however, to leverage one, device manufacturers will need to produce a greater volume of data, along with a more rigorous interpretation of that data than previously required. Full demonstration of clinical, biological, and technical equivalence is required. Two of the three will not be sufficient. Some key points to consider are:

• The Notified Body will now challenge your access to a competitor’s technical documentation if using a competitor product to establish equivalency. For implants and Class III devices, this includes an agreement to access technical documentation for the equivalent device. In most cases, this type of access to proprietary information will not be available.
• The technical criteria chosen to demonstrate equivalence must support the equivalence argument and critical performance specifications for the specific device type under consideration. Product specific standards or side-by-side testing of the equivalent device may help here.
• The simplest way to show equivalency to an existing CE Marked product is to create a table comparing the supporting technical, biological, and clinical characteristics of the two devices. The Notified Body will question any differences and their significance with respect to safety and performance. In cases of significant differences, a medical professional will need to provide formal justification.

What about claiming equivalency to a product that is not CE Marked or sold in the EU? In that case, you would have to make a very good case to your Notified Body why the data is transferrable to an EU population and analyze any safety and performance gaps related to the clinical performance.

Managing the transition from the MDD to the MDR will involve a lot of work and the expert MED Institute scientific communications team is here to help. We can review your technical documentation and current clinical evaluation reports and help with a plan moving forward.

Please visit medinstitute.com or contact us at 855.463.1633 to learn more about our team and capabilities.