MDCG Article 54(2)b interpretation of Regulation (EU) 2017/745

Posted on 02.04.2019

On 22 March 2019, the Medical Device Coordination Group (MDCG) published a document on the interpretation of Article 54(2)b of the Medical Devices Regulation which states:

“The Clinical evaluation consultation procedure shall not be required where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device.”

The communication from MDCG represents a substantial step forward in the direction of rendering the application of the MDR to legacy products more workable, as constantly requested.

MDCG’s interpretation is that MDD and AIMD compliant devices, falling in the category which would require the clinical evaluation consultation (i.e. the scrutiny), will not be subject so such consultation when bringing them to compliance with the requirements of the MDR.