Additional standards for class III implantable devices and class IIb active medicinal devices
A clinical evaluation consultation method is also required for class III implanted devices and class IIb active devices designed to deliver and/or remove a medicinal substance.
This implies that the notified body must forward the manufacturer’s clinical evaluation assessment report to a designated expert panel for a “second view” and suggestion.
Concentrate on PMS technical documentation
When the notified body has assessed the manufacturer’s full range of devices (via TD assessment) during the certification cycle and there is still time left on the certification cycle, the notified body shall focus on the technical documentation relating to post-market surveillance during the remaining audits in that cycle.
When TD sampling is no longer required, the focus of audits will shift to PMS-related documentation.
Audits of future surveillance
Future surveillance audits must be completed within 12 months of the prior audit. These surveillance audits must also include prospective critical supplier audits as determined and incorporated in the audit program of the notified entity. With the first stage 2 audit, a supplier audit may be necessary. Furthermore, during each certification cycle, the notified body must conduct at least one unannounced audit.
During the certification period, the manufacturer is required to notify the notified body of changes to their QMS and product portfolio. Any possible vigilance as well as the required PSURs must be communicated to the informed entity. This data is also used to inform the notified body’s 5-year strategy. Changes may serve as a cause for more TD assessments, special assessments, additional audits, or unannounced audits.
The notified body has the authority to conduct unannounced audits of the manufacturer’s suppliers. Unannounced audits conducted under the MDR often entail the notified body doing or witnessing actual product tests.
The completion of a certification cycle
The notified body will require an application from the manufacturer to obtain re-certification before the conclusion of a certification cycle. This application may or may not be as detailed as the first official submission, depending on anticipated revisions.
To extend the EC certificate with a fresh 5-year validity, the notified body must complete a re-certification audit. Before granting the certificate a new 5-year validity period, the notified authority must check that everything according to the first 5-year plan has been completed and managed appropriately.
When a manufacturer wants re-certification, the notified body must create a new 5-year plan for the upcoming certification cycle. This must encompass everything from the previous cycle, such as requesting technical documentation and conducting new frequent and unannounced audits.
