By Ron Sills, M.S., Nerac Analyst,
Originally Published: October 3rd, 2014
Is your company ready for an audit by your notified body? Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that products meet the essential requirements of the Medical Devices Directive (MDD), and other applicable regulations or recognized standards. Initial device approval certifications will include a review of the company’s technical documentation, which may be a technical file for Class IIa and IIb devices, or a design dossier for Class III devices. In addition, most manufacturers will also obtain a certification for their quality management system (QMS) in accordance with EN ISO 13485:2012. The notified body audit may encompass a review of both the QMS requirements and a review of the technical documentation for approval of devices or product families. Initial review and certification may take one or more auditors several days to fully assess the level of compliance with the QMS and MDD requirements. After certification, the notified body may schedule annual surveillance audits to monitor the on-going compliance and continuous improvement of the QMS.
In 2014 the European Parliament required notified bodies to conduct unannounced audits of medical device manufacturers’, particularly where manufacturing is conducted. This is similar to the FDA’s practice of conducting unannounced inspections. While this may seem somewhat routine for manufacturers, it can be quite unsettling to an organization as they are trying to conduct their normal business operations. It has been reported that several notified bodies have already conducted unannounced audits.
Is your organization ready for a notified body audit, either scheduled or unannounced? The key to compliance is establishing a sound QMS which supports all the necessary requirements for documentation, adherence to all applicable regulatory requirements and standards, and continuous improvement through a review of post market information. This must all be established within the framework of a corporate culture focused on not only meeting, but exceeding customer needs and expectations.
Did you miss our webinar: “Updating Technical Files – Is Your Company Ready for a Notified Body Audit?” You can listen and watch it here!
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