This weeks guidance delineates the steps that a device manufacturer must perform in the pursuit of making application to their notified body. The end result of a successful application process will be the authorization to affix the CE mark of registration onto product packaging and the entry of product into commerce within the EU.
Annex II of the IVDD is critical as it ultimately drives the path for establishing and complying with essential requirements, and hopefully, the eventual approval from your notified body. And significant changes to Annex II are coming.
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.
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…