In September 2013, the EU Commission published Recommendation 2013/473/EU, which details some requirements for notified bodies when performing the systematic unannounced audits. One of these requirements is to sample products at various stages of their production and test them to ensure their compliance.
The auditors are focused on only a couple critical processes during the unannounced audit, and testing is a vehicle that the auditors use to ensure that the output of the process during production is what the manufacturer commits it will be. In other words, where a normal surveillance audit could cover many different processes at a global level, an unannounced audit will go into the roots of only a few processes and products.
Product sampling and testing during an unannounced audit poses a different type of challenge for manufacturers and notified bodies. For notified bodies, this requirement means that they must ensure that the auditors are well-versed in the manufacturer’s type of device in order to understand and interpret test results and records. Some notified bodies, including LNE/G-MED, have made this their normal practice for many years. Manufacturers face different logistics challenges, and have asked a few questions regarding those challenges. While some responses are found in the Recommendation itself, the NBRG worked on a document which is still at an intermediate stage and formally approved, for notified bodies to use in performing the unannounced audits that answers other questions.
Some of these questions are:
Which devices can an auditor request to be tested during an unannounced audit?
The auditor can request that any device is tested during an unannounced audit, regardless of the class. The Recommendation doesn’t specify that this requirement only applies to certain classes or types, but that notified bodies should preferably check “a device taken from the ongoing manufacturing process.”1 This means also that testing isn’t limited to finished devices only, but it includes devices and materials along the entire production process.2
Who tests these devices and materials?
The default rule that notified bodies use is that the manufacturer or their critical subcontractor tests the devices and materials according to their procedures and using their equipment, and the auditor witnesses these tests being performed.3 If the equipment or testing personnel aren’t available at the time of the unannounced audit, it may be extended for an additional day to allow that equipment and/or personnel to be present.
Would the notified body only test materials at the manufacturer?
No, the notified body could ask for tests during the relevant critical subcontractor’s unannounced audit as well.4 Indeed, the guidance document states, “In case there is an option to identify non-conformity at a preceding stage of the value chain, e.g. at the component level or at critical subcontractors, this option is the preference in order to save cost and effort.”5
What if an outside laboratory needs to perform the testing?
According to the Team NB guidance document, if the auditor isn’t able to witness product testing, the tests may be done by qualified engineers either at the notified body’s lab or an accredited third party test lab.6 The default rule is that testing would be performed in the presence of the notified body and a representative from the manufacturer.7
Systematically performing the unannounced audits, as well as the product sampling provisions, are still new to both notified bodies and manufacturers alike. As time goes on and as both parties have more experience, the challenges that both parties face will become assets in protecting the public health. If you have any questions about the unannounced audits and testing during the unannounced audits, contact us.
1 473/2013/EU Annex III.3.
2 Interim NBMed consensus version NBRG, Guidance for the Interpretation and Implementation of the Commission Recommendation on Audits and Assessments Performed by Notified bodies in the field of Medical Devices (2013/473/EU): Testing During Unannounced Audits. Page 4.
3, 4, 5, 6, 7 Id.