The European Commission Recommendation on audits and assessments performed by notified bodies in the field of medical devices was published on September 24th 2013.
The purpose of the Recommendations is to enhance patient safety especially following the Poly Implant Prothèse (PIP) breast implants scandal in France in 2010.
The new Recommendation, Annex III, stipulate tighter regulations for unannounced audits of manufacturers of medical devices:
“Notified bodies should carry out unannounced audits at least once every third year. Notified bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the type in question are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer. The timing of the unannounced audits should be unpredictable. As a general principle an unannounced audit should not take less than one day and should be executed by at least two auditors.”
The notified body can also make unannounced audits at critical sub-contractors or crucial suppliers:
“Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer’s critical subcontractors or crucial suppliers if this is likely to ensure more efficient control. This applies in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier.”
The implications for you as a Manufacturer of CE marked medical devices
As a Manufacturer you have to plan and ensure that your company is prepared for unannounced audits which will take place with a minimum interval of once every three years. The auditors will require access to the premises, documentations and technical files. Furthermore relevant staff should be available for assistance. The expense of an unannounced audit will be at the cost of the Manufacturer.