The Medical Device Coordination Group (MDCG) have issued a revised guidance on the criteria exempting medical devices from pre-market clinical evaluation consultations with expert panels.
The pre-market clinical evaluation procedure should not be required in the following circumstances:
- a firm is renewing certification under the Medical Device Regulation (MDR);
- 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”;
- where the principles of the clinical evaluation of the device type or category have been addressed in a 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 specification for clinical evaluation of that kind of device.
The MDCG have responded to questions about the interpretation of “device already marketed”, and clarified that it applies to devices marketed under the old directives and new regulations.
The guidance also provides an addendum on procedural aspects, such as what to provide to a notified body alongside the conformity assessment application. This includes:
- a statement that it has marketed the device in question for the same intended purpose under the relevant Directive;
- copy of the last issued certificate(s) together with the certificate history;
- a description of the modifications introduced to comply with the MDR. (Notified bodies should verify that these modifications do not negatively affect the benefit-risk ratio.)
For more information on the MDCG interpretation of the guidance, click here.