On September 24th 2013, the European Union Commission published a recommendation (2013/473/EU) regarding assessments and audits to be performed by Notified Bodies in the field of medical devices. This would apply to many areas of the medical device industry including medical device contract manufacturers.  An important aspect of this recommendation is the mandatory requirement of unannounced audits for all CE certified medical device manufacturers and/or their subcontractors and critical suppliers at least once every three years. Unannounced audits apply for all legal manufacturers, regardless of whether the devices are covered under the MDD, AIMDD, or IVDD.

 medical device contract manufacturer auditsIf critical processes are subcontracted or purchased from a supplier, the Notified Body may also conduct an unannounced audit on the facilities of subcontractors and suppliers where a significant part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier.

Where does the authority come from? The Medical Device Directives (for example Directive 93/42/EEC Annex II, No. 5.4) empowers Notified Bodies to facilitate unannounced audits where necessary.

The European Commission Recommendation (2013/473/EU), which has been accepted by all Member States, outlines the importance of verifying the ongoing day-to-day compliance with legal manufacturers. Therefore, the European Commission expects Notified Bodies to perform unannounced audits in addition to product assessments and quality system assessments.

Are your contract manufacturers and suppliers aware of this requirement? If not, a great place to start would be in the Manufacturing Agreements or Quality Agreements. Communication and expectations are critical for those unannounced audits, two things that are extremely important to the Cogmedix team. Prior planning will lead to a better outcome for everyone.

-Scott Cook, Director of Quality and Compliance