Procedure for Requesting Exceptional Use of Non-CE Marked Medical Devices in Belgium

1. Legal Basis and Scope

FAMHP may grant derogation from conformity assessment procedures under Article 59 of Regulation (EU) 2017/745 (MDR) for medical devices or Article 54 of Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices. This allows placing on the market or putting into service of specific non-CE marked devices in Belgium when justified in the interest of public health, patient safety, or health. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

2. Eligibility Criteria

Requests must be duly justified and demonstrate exceptional circumstances:

• Absence of suitable alternatives (any device, product, or treatment achieving similar purpose).
• Significant expected benefit for diagnosis or treatment compared to available alternatives. Off-label use of CE-marked devices is not covered and no derogation request can be submitted. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

3. Eligible Applicants

Applications are limited to:

• The manufacturer.
• Its authorised representative.
• A mandated third party (with proof of mandate via contract). The manufacturer or authorised representative remains responsible for compliance with applicable legislation. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

4. Types of Derogation

a) Compassionate Use (Individual Device for Specific Patient)

Form divided into Part 1 (completed by applicant: manufacturer, authorised representative, or mandated third party) and Part 2 (completed by the treating physician).

b) National Derogation

For requests not specific to an individual patient. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

5. Required Documents

• Completed application form (specific to type).
• For compassionate use: Part 1 by applicant and Part 2 by physician.
• Proof of mandate if third party applicant.
• Detailed justification demonstrating exceptional circumstances, absence of alternatives, and significant benefit. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

6. Submission Process

Submit applications electronically to derogation.meddev@fagg-afmps.be. Forms are available in English:

• Compassionate use form.
• National derogation form. If issues opening forms in browser, save and open with a PDF reader. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation

7. Important Notes

Derogation authorizes use only in Belgium. No fees or specific processing times are mentioned. Page last updated 06/12/2024. Source: FAMHP Request for Exceptional Use Page https://www.famhp.be/en/humain/produits_de_sante/dispositifs_medicaux/utilisation_exceptionnelle/demande_dutilisation