Criteria for the exemption of medical Devices from Premarket Clinical consultations
                     Criteria for the 
Exemption of Medical 
Devices from Premarket 
Clinical Consultations
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Contents
1 Circumstances under which consultation is not required
2 Details to be submitted to the Notified Body
3 About VISTAAR
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Criteria for the Exemption of Medical Devices 
from Premarket Clinical Consultations
A new interpretation of Medical Device Regulation (MDR) recently updated 
Article 54 (2)b has been forwarded by the Medical Device Coordination Group 
(MDCG). According to MDCG, there are certain criteria under which medical 
devices can be exempted from premarket clinical evaluation consultations to 
be held before an expert panel.
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Circumstances under which consultation is not 
required
1. When a firm is undertaking the renewal process under the Medical Device 
Regulations norms.
2. A manufacturer designs a device through the modification of a pre-existing 
and pre-marketed medical device and they both serve the same purpose. In 
such cases, the manufacturer must satisfy the notified body with the ratio of 
risk and benefit that might be encountered while using this modified medical 
device.
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Circumstances under which consultation is not 
required
3.   If the clinical evaluation principles of the device have been highlighted in a 
common specification referred to in Article 9 and the same needs to be 
confirmed by the notified body that the medical device’s clinical evaluation 
as conducted by the manufacturer is compliant with the form of evaluation 
needed for the medical device. 
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Details to be submitted to the Notified Body
In addition to the filed application for conformity assessment, the following things are 
to be submitted by the manufacturer to the Notified Body.
• a. A statement that the medical device in question has already been marketed as 
per the previous directive for the pre-intended purpose.
• b. Last issued certificate’s copy along with its history.
• c. List of modifications that have been implemented to make the medical device 
compliant to the Medical Device Regulations
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Criteria for the Exemption of 
Medical Devices from Premarket 
Clinical Consultations
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