This week, we discuss Annex III (EC Type – Examination) of the Medical Device Directive. There are two takeaways: Device manufacturers should ensure all of the technical documentation is readily available for their notified bodies during the examination process. And second, remember your responsibilities associated with certificate and data retention – there is a mandatory retention period of either 5 or 15-years, depending on the application of the device.

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This week, we discuss Annex II (EC Declaration of Conformity – full quality assurance system) of the Medical Device Directive, which delineates the regulatory requirements necessary for compliance with the Directive employing an acceptable quality assurance system. Annex II is really a straightforward document with requirements relatively easy to comprehend. There are three major components: (a) application and approval of a QMS by a notified body; (b) application and approval of the actual device applic…

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