Have you implemented the guidance in MedDev 2.7/1 Revision 4 on clinical evaluation or have a plan to do so?
Does your clinical evidence rely on equivalence with another device, and, if so, are you able to meet the additional expectations for equivalence as defined in the current guidance and in a much more restrictive manner under the Regulation?
One of the key areas that device manufacturers will need to review with the new Regulation is the clinical evidence that they have to support their device and whether that clinical evidence relies on demonstration of equivalence with a comparator device.
Can you demonstrate that your device is equivalent to its comparator, based on scientific justification, in regard to technical, biological and clinical characteristics?
If you require support in writing or updating your clinical evaluation report, please do contact us for an informal discussion with one of the medical device team members at Regulis.