To obtain CE marking manufacturers must prepare and keep technical documentation that shows how each medical device was developed, designed and manufactured. The way in which this is done is defined in the manufacturer’s quality system management (QMS). This process should not be underestimated. Extensive coverage of different sections may be created in different departments and/or locations. It is therefore essential that manufacturers keep a strict record of their technical files and update if changes are made.
Different Notified Bodies may prefer different technical file structures and may place emphasis on different aspects. For example TÜV in Germany may expect a very detailed technical file, whereas G-Med in France may concentrate on certain critical steps such as risk management and its incorporation in the overall quality system. The Global Harmonisation Task Force (GHTF, now the International Medical Device Regulators Forum - IMDRF) has published a guidance document in order to harmonize dossier requirement.