Last April, the Medical Device Coordination Group endorsed this guide for establishing the equivalence in the clinical evaluation addressed to manufacturers and notified bodies.

To generate clinical data concerning the safety and performance of medical devices for the purpose of CE marking, carrying out a clinical investigation is the most direct way. However, if prerequisites are fulfilled, manufacturers can also use clinical data from clinical investigations or scientific literature and reviews from device(s) for which an equivalence to the device in question can be demonstrated.

Among the prerequisites that shall be fulfilled for the demonstration of equivalence, it is important to recall that:

• For a manufacturer of implantable devices and class III devices:
  • You shall perform clinical investigations, except if the device has been designed by modifications of a device you already marketed, and equivalence can be demonstrated according to the MDR or for devices mentioned in MDR Article 61(4) (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors)
  • You can still claim equivalence to an already marketed device not manufactured by you, but you must have a contract in place that allows full access to the technical documentation of this device on an ongoing basis. The MDR also requires that the original clinical evaluation of the equivalent device has been performed in compliance with the requirements of the MDR.
• For devices other than implantable devices and class III devices and where you want to claim equivalence, MDR Article 61 (3) is applicable. In this case, it is possible to claim equivalence to a device that is not CE-marked providing that:
  • All relevant MDR requirements regarding equivalence and clinical evaluation are met.
  • You shall have sufficient levels of access to the data relating to devices with which you are claiming equivalence.
  • If the presumed equivalent device is from another manufacturer, there is no MDR requirement of a contract between the manufacturers for regulating the access to the technical documentation.
  • Clinical investigations were conducted in accordance with international guidelines.
  • Clinical data meet the requirements of the MDR, and a justification is provided whether the clinical data are transferrable to the European population.

Equivalence of products without an intended medical purpose are also covered in the MDCG 2020-15.

How do you claim equivalence?

Claiming equivalence is still possible, and it shall be demonstrated according the MDR requirements. The MEDDEV 2.7/1 rev. 4 guide should still be used during the process of demonstrating equivalence under the MDR, but with some novelties.

In the file in attachment, we provide a table derived from the Annex I of the MDCG 2020-15 that you can include in the clinical evaluation report to claim equivalence. There, we highlighted, and we explained in text boxes the main novelties (for full details also on specific devices, please refer to the MDCG 2020-15).

In summary, it is still possible to claim equivalence under the MDR in most of the cases with additional requirements, but it became very hard for implantable devices and class III devices. Data from similar devices (devices belonging to the same generic device group for which an equivalence cannot be demonstrated) are still useful for a variety of purposes listed in the MDCG 2020-15.

We provided a quick overview on the topic, and we recommend you refer to the MDR, the MEDDEV 2.7/1 rev. 4 guide, and to the MDCG 2020-15 if you are working on this aspect. If you have questions or need support, please contact us at info.ch@confinis.com.

If you liked this blog and you are interested in sufficient clinical evidence for legacy devices, stay tuned for our next post in a week!

Authors: Dr. Martina Coscia, Dr. Andrea Biasiucci

Credits: the picture for this blog series has been inspired from a poster by R. Pradhan, S. Shrestha and U. Satyal entitled “Development of a digital tool for risk management, clinical evaluation and post-market surveillance of medical devices” for the 2020EuroConvergence conference.