MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b that was so far subject to different interpretations.
Second paragraph of Article 54 excludes certain type of Class IIb and III devices from otherwise mandatory clinical evaluation consultation procedure that involves expert panels:
”2.The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
(a) in the case of renewal of a certificate issued under this Regulation;
(b) 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; or
(c) where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.”
MDCG focuses on the interpretation of the wording ”already marketed” and ”modification” (underlined above in b), and states:
”already marketed’’ covers devices marketed under the Directives and the Regulation; and not only the Regulation;
‘’modification’’ for devices marketed already under the Directives shall be understood as limited only to those modifications needed in order to comply with the new legal requirements introduced by the MDR. *
*These devices will anyhow be subject to all applicable new MDR requirements, including those ones related to the clinical evaluation, and will need to be assessed by notified bodies against these new (and higher) requirements. This aspect together with the increased notified bodies’ oversight foreseen under MDR should guarantee a high standard of safety for these products.
Become MDlaw.eu member and stay updated will all relevant MDR news!