The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification of Article 54(2)b is “extremely urgent.”
The Medical Devices Coordination Group (MDCG) evaluated the three criteria in Article 54(2) of the EU’s medical device regulation (MDR), which will exempt certain class III and class IIb devices from the requirement to involve expert panels in premarket clinical evaluation consultation procedures. The group concluded that the second criterion lacks clarity, particularly as it relates to the word “marketed.”
Article 54(2)b states the MDR exemption may apply to medium/high-risk or high-risk devices “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 interpretation of the word “marketed” in point (b) is “unclear” and has “raised questions from the public and from member states,” MDCG said. This is because point (a) specifies an exemption may apply “in the case of renewal of a certificate” issued under MDR but point (b) fails to indicate whether “a device already marketed” refers to a device marketed under the current medical device directives or MDR.
The urgency to clarify the interpretation issue posed by Article 54(2)b relates not only to MDR’s official entry into force on 26 May 2020, but also to the pending work of the EC on the regulatory exemption.
The EC faces a slew of mandates for the transitional periods on MDR and the in vitro
diagnostic regulation (IVDR), which is set to be fully implemented by 26 May 2022. Under MDR, the EC was directed to arrange for designating expert panels to carry out the clinical evaluation consultation procedure provisions of Article 54 through implementing acts and in consultation with the MDCG.
The MDCG noted clarification of the Article 54(2)b issue “is extremely urgent, notably due to its impact on the future workload of panels and hence on relevant budget and workload estimations” as it nears the launch of procedures to establish expert panels. It offered two considerations to address the issue.
The considerations noted the co-legislators “would have explicitly stated” their decision to “restrict the application of point (b) to devices marketed uniquely under MDR” and that Article 54 is one of several MDR articles that were “written at the end of the negotiation process with a view to smoothen implementation of the new regulation.” MDCG argued the term “device already marketed,” based on these considerations, “cannot be intended to refer to a device already marketed uniquely under” MDR.
Another Article 54(2)b issue relates to the interpretation of the modifications eligible for exemption of the premarket clinical evaluation consultation procedure when modifying devices already marketed under the directives. The MDCG added that “the word ’modification’ shall be meant as limited only to those modifications needed in order to comply with the new legal requirements introduced by MDR.”
The MDCG document follows on the heels of the first corrigenda
for MDR and IVDR, which included 14 and 17 corrections, respectively. It also comes after the first in a series of MDR/IVDR guidances was issued
by the European Medicines Agency last month and after the EC’s latest updates
to its MDR/IVDR implementation rolling plan, noting recent MDCG documents on unique device identification.
MDCG 2019-3 Interpretation of Article 54(2)b
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe