BASG Confirmation Process for Exporting Non-Medical Devices to Third Countries

1. Purpose of the Confirmation

The Confirmation for Non-Medical Devices (CNM) is issued for products not placed on the market as medical devices by the manufacturer but which may be perceived as medical devices by authorities in non-EU countries (e.g., general laboratory supplies). The confirmation states that these products are not marketed as medical devices. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

2. Eligibility

CNM can only be requested by manufacturers or authorised representatives established in Austria. Previously issued CNMs cannot be copied; new requests are required for each application. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

3. Required Documents and Preparation

Applicants must:

• Download and complete the request form and document overview list.
• Create a product list using the template provided.
• Provide supporting documents proving the product is not a medical device. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

4. Application Submission

Submit the completed form, overview list, and documents via email to cfs@basg.gv.at. Use a specific subject line format including country/countries, company name, number of products, and applicable directive/regulation. As of August 29, 2025, the updated request form must be used. Draft versions are no longer provided before issuance. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

5. Fees and Payment

Fees apply per the BASG Fee Regulation under the Health and Food Safety Act. Fees are incurred upon submission and charged per identical CNM requested simultaneously, regardless of outcome (including withdrawal or rejection). Partial refunds apply in specific cases (e.g., early withdrawal: 10%; formal rejection for incompleteness: 10%). Changes after submission are limited and do not reduce fees. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

6. Processing and Issuance

Applications are processed in order of receipt. Processing time varies based on volume and application quality/completeness and cannot be predicted. Issued CNMs are sent only to the applicant, who handles further legalisation if needed. Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices

7. Contact

For pre-submission inquiries: cfs@basg.gv.at Source: BASG Confirmation for Export of Non-Medical Devices Page https://www.basg.gv.at/en/companies/medical-devices/confirmation-for-the-export-of-non-medical-devices