MDCG explains when devices can be exempt from premarket clinical consultations

Regulatory NewsRegulatory News
| 09 April 2020 | By Zachary Brennan 

The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels.

According to the text of the article, the clinical evaluation consultation procedure shall not been required when:

(a) a firm is renewing certificate under MDR;

(b) a 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”;

(c) “where the principles of the clinical evaluation of the device type or category have been addressed in a CS [common specification] 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.”

But the MDCG says questions have been raised with (b) because it is unclear if a “device already marketed” refers to devices already marketed under the device directives or the new regulations.

However, the guidance also says that 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.’”

Industry group MedTech Europe said the MDCG’s interpretation "is that MDD [medical device directive] and AIMD [active implantable medical device] 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."

What to Provide to the Notified Body

The updated guidance also adds an addendum on procedural aspects. The MDCG explains that alongside the application filed under the applicable conformity assessment procedure, the manufacturer will provide the notified body with: A statement that it has marketed the device in question for the same intended purpose under the relevant Directive, a copy of the last issued certificate(s) together with the certificate history, and a description of the modifications introduced to comply with the MDR.

Notified bodies should verify that the “modifications” do not adversely affect the benefit-risk ratio.

“In particular, the notified body will verify: that the device in question had a valid certificate under the Directives, in case the certificate has been withdrawn, suspended or expired, if there is an impact on compliance with the general safety and performance requirements, and that there is no pending assessment of changes for the device or outstanding non-compliance,” the MDCG says.

In addition, notified bodies will verify the description of modifications and assess if they are limited only to those needed to comply with the new legal requirements introduced by the MDR. “Limitations of the intended purpose of the device should not trigger the consultation procedure in accordance to Art. 54,” the MDCG says.

But if any of these conditions are not fulfilled, the MDCG says the notified body will follow the consultation procedure in accordance with Art. 54.

Meanwhile, the MDCG says that clarifications in respect to the applicability of Art. 54(2)b with regard to devices already marketed under the MDR are to be provided in a separate guidance.

MDCG 2019-3 Interpretation of Article 54(2)b rev 1


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