- 1. Derogation form the conformity assesment procedures under Art. 59 of Regulation 2017/745 or Art. 54 of Regulation 2017/746
Regulations 2017/745 (medical device) and 2017/746 (in vitro diagnostic medical devices) provide for a "derogation from the conformity assessment procedures". According to Articles 59 and 54 respectively, the FAMHP can authorise the placing on the market/putting into service on Belgian territory of a non CE-marked device.
This request must be duly justified and in the interests of public health or patient safety or health.
Below, you will find a form for derogation requests, either for one or more device(s) for a specific patient, or for a national derogation for a device.
a) Derogation for individual device(s) for a specific patient ("compassionate use")
The following form must be used to request a derogation for a specific patient.
The first part of the form must be completed by the applicant (manufacturer, authorised representative or a third party mandated by them) and the second part by the physician concerned.
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The various documents must be sent in electronic format to derogation.meddev@fagg-afmps.be.
b) National derogation for a device
The following form must be used for all other derogation requests:
Form to request a derogation:
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The various documents must be sent in electronic format to derogation.meddev@fagg-afmps.be.
c) Criteria for granting a derogation request (non-exhaustive list)
The legislation stipulates that the placing on the market or putting into service of a non-CE marked device can only be subject to a derogation in exceptional circumstances. It must be demonstrated that the use of the device is in the interest of public health and/or patient safety or health, in particular through:
- the absence of an alternative : an alternative is not necessarily a device with exactly the same characteristics. By alternative, we mean any other device or product/treatment that could achieve a similar purpose.
- demonstrating that the expected benefit is significant due to the use of this device compared with the alternative diagnosis(es)/treatment(s) available.
d) The applicant
A derogation request based on Art. 59 of Regulation 2017/745 or Art. 54 of Regulation 2017/746 is made in order to "authorise the placing on the market or putting into service". Consequently, only those authorised to carry out these acts may sign the document "Part 1 - to be completed by the applicant." In other words,the applicant can only be:
- the manufacturer or its authorised representative ;
- any other person duly mandated by the manufacturer or its authorised representative (a contract signed by both parties must prove this mandate).
When making a request, the manufacturer and/or its authorised representative must comply with the relevant legislation in force (even in the case of an derogation for an individual device for a specific patient). The manufacturer and/or its authorised representative assumes responsibility for this request and for compliance with the applicable legal requirements.
- 2. Off-label use
The legislation relating to devices does not regulate the off-label use, i.e. the use of a CE-marked device outside the manufacturer's intended purpose after it has been placed on the market (for example, at the initiative of a healthcare professional). In other words, when a device is legally placed on the market for a given indication, Regulations 2017/745 and 2017/746 do not regulate its use.
No derogation request can be submitted for an off-label use.