지침,참고문헌 | MDCG 2019-3 Interpretation of Article 54(2)b

MDCG 2019-3 Interpretation of Article 54.pdf (488.9K) [29]

Interpretation of Article 54(2)b
Article 54(2) of the MDR lays down three criteria that exempt devices from the pre-market clinical evaluation consultation procedure with the involvement of expert panels. In particular that article states that:
“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”.
Interpretation of point (b) of Article 54(2) is unclear, notably in relation to the application of the word “marketed”. In fact, while in point “a” the co-legislator explicitly indicates that the certificates referred to are those issued under the new Regulation, in point “b” there is no indication of whether a “device already marketed” refers to devices already marketed under the Directives or the Regulations.
This has raised questions from the public and from Member States.
As we are about to launch the procedures for the establishment of expert panels, clarification of this issue is extremely urgent, notably due to its impact on the future workload of panels and hence on relevant budget and workload estimations.
The following considerations seem to indicate that the expression “device already marketed” cannot be intended to refer to a device already marketed uniquely under the new Regulation:
 If the co-legislators had decided to restrict the application of point “b” to devices marketed uniquely under the MDR, they would have explicitly stated so, as they did for point “a”;
 Article 54, together with other Articles (such as Article 61(6) and Article 120(3)), was written at the end of the negotiation process with a view to smoothen the implementation of the new Regulation. Therefore the interpretation of the exemption should be understood in line with the spirit and intention of the co-legislators.
It has to be noted that, in respect to devices that have been marketed already under the relevant Directives, the word “modification” shall be meant as limited only to those modifications needed in order to comply with the new legal requirements introduced by the MDR.