What is a Declaration of Conformity (DoC)?
The DoC is a one-page document that "declares" your device is compliant with the applicable directive. It is a legally binding document. The DoC is prepared and signed as the last step in the regulatory process.
How is a Technical File formatted?
Most Technical Files follow Summary TEchnical Document (STED), a harmonized format for submitting information for regulatory approval of devices. The format was created by the former Global Harmonization Task Force (GHTF). However, some NBs publish extensive documents describing their position on content and formatting. Emergo can format your technical file to STED or your Notified Body requirements, as needed.
How will Europe's new Medical Device Regulation (MDR) change technical file requirements, contents, and formatting?
The MDR will come into effect in late 2019 or early 2020. With new requirements for clinical data and risk assessment, and an expanded product scope, it is possible that technical files will need to be more detailed and robust to demonstrate compliance with the new regulation. To learn more about the new MDR changes, download our 15-page white paper.