The technical documentation should include at least:

• your name and address, or those of any authorised representatives
• a brief description of the product
• identification of the product, for example, the product's serial number
• the name(s) and address(es) of the facilities involved in the design and manufacture of the product
• the name and address of any notified body involved in assessing the conformity of the product
• statement of the conformity assessment procedure that has been followed
• the EU declaration of conformity
• label and instructions of use
• a statement of relevant regulations to which the product complies
• identification of technical standards with which compliance is claimed
• list of parts
• test results

Guideline Submission Processes of Clinical Investigations according to MDR in Belgium

An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.

Free Sales Certificates (FSC)

- Any dysfunction or any change of the characteristics and/or performance of a device, and any inadequacy in the labelling or instructions, which might lead to or have led to death or serious relapse in the state of health of a patient, a user or a third party.

- Any technical or medical reason related to the characteristics or performance of a device for reasons shown in the previous paragraph and having led to the systematic withdrawal from the market by a manufacturer of devices of the same type.

For all reportable events which indicate an imminent risk of death, serious injury, or serious illness and that require prompt remedial action for other patients/subjects, users or other persons, or a new finding to it: Immediately, but

The FSN provides information on the identification of the affected devices and the reasons for the field safety corrective action. The FSN describes the risks to patients, users or others affected by the problem. It also provides the measures to be taken by users to reduce or eliminate the risk.

For low-risk classes, no prior notified body approval is needed, except for sterile devices and reusable surgical instruments. Custom-made devices, systems, and procedure packs do not need CE marking, but must be approved by a notified body if they are not compatible or if the manufacturer wants to extend the use of their device to other indications.