Unannounced Audits

Information about unannounced audits performed by Notified Body

Applicable for manufacturers holding a valid CE-certificate according to the 93/42/EEC Medical Device Directive.

The European Commission Recommendation 2013/473/EU on audits and assessments performed by notified bodies in the field of medical devices was published on September 24th 2013.The purpose of the Recommendation is to enhance patient safety especially following the Poly Implant Prothèse (PIP) breast implants scandal in France in 2010.

Annex III in the Recommendation, stipulate tighter regulations for unannounced audits of manufacturers of medical devices.

An unannounced audit is an audit of a manufacturer or a significant critical subcontractor (e.g. outsourced design, manufacturing, sterilization) or a crucial supplier (e.g. component, raw material) where the manufacturers are not informed prior to the audit.
The unannounced audits are product focused audits. Usually the scope of the audit is to verify that manufactured devices (on the day of the audit) are in compliance with the technical file, also key processes are audited. However, the audit scope depends on the reason for selecting the company.

The purpose of an unannounced audit is to collect evidence in order to document compliance or lack of compliance in relation to the audit scope.

The duration of an unannounced audit is, as a rule, minimum one day and executed by at least two auditors on site. Time for preparation and reporting of at least one man day is in addition.

Manufacturers must have appropriate contracts with their subcontractors that allow an unannounced visit by their Notified Body.

Expectations for the frequency of unannounced audit

References:

Commission recommandation 2013/473/EU:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN:PDF