For the export of products that are not marketed as medical devices but may appear to authorities in countries outside the European Union to be medical devices (e.g., general laboratory supplies), an official confirmation stating that these products are not placed on the market as medical devices by the manufacturer may be required.
 

These confirmations for the export of non-medical devices (CNM) are issued by the Federal Office for Safety in Health Care (BASG) upon request by the manufactureror the authorised representative, after verifying that the necessary conditions are met.
 

Please note:

• A CNM (formerly “Bestätigung allgemeiner Laborbedarf”) can only be requested by the manufacturer or the authorised representative based in Austria.
   
• A request may include a maximum of 500 products.
  If CFS are required for more products, these must be split across several requests.
   
• Confirmations for the export of non-medical devices issued by the BASG are valid for a maximum of 2 years.
   
• Copies of previously issued CFS cannot be provided. A new request must be submitted.

The request for CNMs is subject to fees in accordance with the BASG Fee Regulation under the GESG (Health and Food Safety Act, BGBl. Nr. 63/2002, as amended).
Fees are incurred at the time the request is submitted. This also applies to each identical CNM requested simultaneously.

Important: If you are unsure about the required documentation, please contact us via email at cfs@basg.gv.at  before submitting your request.

Fees are charged regardless of whether the request ultimately results in the issuance of an CFS, including in cases where the request is withdrawn by the applicant or rejected by an official decision.

Withdrawal of a request
According to Art. 13 Para. 7 of the General Administrative Procedure Act 1991 (AVG), BGBl. Nr. 51/1991, as amended, a request may be withdrawn by the applicant at any time during the administrative procedure.

However, the request is subject to the appropriate fee, depending on the stage of the procedure at the time of its withdrawal.

• If the withdrawal occurs before all documents required for substantive review have been submitted, 10% of the original fee is charged.
• If the withdrawal occurs at a later stage, the full fee is due.

Changes after submission
Changes that alter the nature of the request are not permitted after submission.
Therefore, adding or replacing products in the product list or adding further countries is not possible within a submitted request.
Allowed changes:

• Reduction of the number of products
• Replacement or removal of countries

A reduction in the scope of the request does not reduce the fee. Fees are based on the originally submitted scope.

Rejection of a request

In the case of a formal rejection, 10% of the applicable fee will be charged. Rejection occurs in the following cases:

Lack of eligibility of the request:

• If the manufacturer or authorised representative is not based in Austria

Use of the wrong request form:

• The request concerns medical devices or in vitro diagnostic medical devices

Incomplete request:

• If essential documents are missing, the applicant will receive a request for improvement under Art. 13 Para. 3 AVG.
• If the missing documents are not submitted within the given timeframe, the request will be formally rejected.

Dismissal of a request

If the request is dismissed by decision, the full fee is charged. This occurs when:

Non-compliance:

• During the substantive review, non-conformities are identified.
  The applicant is given the opportunity to respond under Art. 45 Para. 3 AVG.

If the non-conformities are not fully resolved within the deadline, the request will be dismissed. 

• Step 1: Read instructions and download current version of documents
• Step 2: Fill in or update the overview list of documents
• Step 3: Create product list (products requested for) in the document overview list. Please use a copy of the template worksheet tab, as it contains the required headers and footers necessary for issuing the CNM.
• Step 4: Fill in new request form
• Step 5: Send the request form, document overview list and documents to: cfs@basg.gv.at
• Please format the subject line of the email as follows:
  CNM country or countries (or, for multiple CNMs: number of CNMs), company, number of products, Directive or Regulation

Examples:

• i. CNM Taiwan, Example GmbH, 54 devices, Directive
• ii. 10 CNMs, Example GmbH, 79 devices, Regulation

Please note:

When requesting conformations for the export of non-medical devices, the current version of the request form (request form) must be used.

If this is a subsequent application, always use the current version of the overview list of documents provided by the BASG. 

For the evaluation, all relevant documents must be provided for each device included in the request (please refer to the instructions for requesting a confirmation for the export of non-medical devices for further details).

The documents must be provided in German or English.

Requested CNM are created in accordance with the device list created by the manufacturer in the overview list of documents. Accordingly, changes in the overview list of documents must always be transferred to the device list. 

Issued confirmations for the export of non-medical devices will be sent exclusively to the applicant. 
Applicants must obtain the additional certification from the BMEIA themselves at the Office for Consular Legalisations (contact for legalisation – BMEIA – Ministry of Foreign Affairs of Austria). 

For the sake of completeness, the BASG points out that request will be processed in the order in which they are received. The time from the request submission to the completion of the processing of a request cannot be predicted, as this depends both on the fluctuating volume of requests and on the quality and completeness of the individual requests.

The AVG generally provides for a decision period of 6 months. These decision deadlines will be suspended by any subsequent submissions. 

• Instructions for requesting a confirmation for the export of non-medical devices
• Documents overview
• Request form

 Links

• Fee regulation (section XIII)