No matter what is the classification of your device, and which route to compliance you take, an essential element of meeting the requirements of the IVD directive is the ‘Technical File’, which is the repository for all the product design, qualification and manufacturing data, including the risk management file, harmonised standards or CTS applied, device labelling and, where applicable, clinical data and sterilization details.
For certain types of device, such as Annex II devices and 'devices for self testing’, review and approval of the Technical File by a Notified Body is necessary prior to marketing (commonly known as the ‘Design Dossier’ review).
GEMAR can help you construct your Technical File to meet the requirements of your chosen route to compliance - contact us for further information.