CMC


WHAT IS UNANNOUNCED AUDIT?


To improve the patient safety, the notify body have published The European Commission Recommendation 2013/473/EU relating to audits and assessments.

There was a remarkable point in this publication. UNANNOUNCED AUDIT of medical devices manufacturers.

Manufacturers do not know about the audit, that is why it called unannounced audit. The audit is made by subcontractor or a supplier who have an appropriate contract with the manufacturer. These types of audit are focused in a particular product. The reason is to verify is the product meet with the technical file, document compliance or compliance to the audit scope.

The duration is in total around 4-5 days.

In the attached image, you can see the frequency for an unannounced visit.