Hello Dimitri, thanks for posting this question. I do not have the publications you are seeking, but I would be interested, as well. For the clinical study side, we, too, are seeing more unannounced and also announced audits of the clinical study suppliers (especially CROs and core labs), as these are often where the key risk areas lie. I do see this as a shift in focus in audits, to align with the more risk-based approach overall across industry. I would be interested in learning more from others as well. Grazie! -Sarah

Anthony Molliex Actually I think it is the opposite. For example, the german ministry of health has published in June an agreement regarding the audits, to decrease the frequency of unannounced audits for class IIb non implantable medical devices manufacturers: http://www.dm-experts.fr/wp-content/uploads/2017/01/06-13_Publication-englisch.pdf

Annas Al-Omari, CLPM https://www.namsa.com/european-market/unannounced-notified-body-audit/

I saw this few months ago and it a good insight on what NAMSA is expecting from those unannounced audits.
I hope it helps.

our notified body (SGS) is conducting unannounced audits on a regular basis now. We expect one about every 3 years. We have also had an unannounced audit as a supplier.

I have heard of a few suppliers/ subcontractors being subject to unannounced audits by a notified body on behalf of the legal manufacturer. In all the cases I have heard about, it has been for Class III and Class IIb devices.

The requirement is for all legal manufacturers to be audited at least every three years unannounced, so I would expect most of the reputable notified bodies to have finished this task before the end of the first 3 year period in September 2017.

The competent authorities are likely to be getting some data through on unannounced audit metrics from the notified bodies that they designate. I wouldn’t expect this data to be openly published, but I may be mistaken.

Dimitri Dalmonego Thank you all for your comments!