All of the following points should be considered in relation to the new legislation:
a). There is a high emphasis on the need to audit the premises of the (legal) manufacturer and also critical subcontractors and suppliers. This will lead to the need to visit all manufacturers annually including own brand labellers and to increased audits of critical subcontractors and suppliers where the manufacturer’s control is judged inadequate.
b). Notified Bodies will need to assess more critically whether the organisational structure and the qualification and competence of managers and staff is adequate to ensure compliance. Major failures of compliance will result in the Notified Body questioning whether the manufacturer has adequate regulatory, quality or technical expertise within the organisation.
c). In future, it will not be sufficient to demonstrate that all devices are correctly classified, that technical documentation is complete (etc.). The manufacturer must have up to date procedures that describe all the processes that ensure regulatory compliance.
d). Risk management will continue to be considered a critical aspect of the manufacturer’s QMS and the application of the process to devices will be regularly audited. Manufacturers should be aware that ISO 14971 alone is not sufficient and the EU regulatory requirements of reducing risks ‘as far as possible’ and applying safety principles ‘compatible with the state-of-the-art’ must also be incorporated into the risk management process.
e). Clinical evaluation for medical devices and performance evaluation for in vitro diagnostic medical devices will remain a high priority, so manufacturers should expect their processes and their decisions and documented justifications to be challenged more often during audits.
f). The Recommendation provides a non exhaustive list of critical processes on which parts of the audit will focus: ‘design control, establishment of material specifications, purchasing and control of incoming material and components, assembling, software validation, sterilisation, batch release, packaging and product quality control.’ The expectation of the Notified Body will be that the manufacturer must demonstrate tight control even if this activity is subcontracted.
g). Notified Body audits may in future include in the audit a reconciliation check of purchased quantities of critical material or components against production. This will be of particular importance for high-risk devices.
h). Manufacturers will be expected to use all available sources of post-market surveillance data including (where applicable) distributors, users and patients.
i). The Recommendation makes it clear that Notified Body audits should be annual, a frequency already adopted by most Notified Bodies.
j). The quality manual and policies must demonstrate that the (legal) manufacturer, including when there is an own brand arrangement, actively retains responsibility for all the Directive requirements and all the critical processes. All manufacturers must have access to relevant technical documentation and must make all physical manufacturing sites available for the Notified Body audits. Current guidance on own brand labelling will have to be amended to reflect these changes.
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