RegulatoryOfficial

Austria's BASG holds first round table with industry on medical device free sale certificates

🇦🇹 BASG · Thu 22 Oct 2026

Industry associations and the medical devices market surveillance authority discussed how to speed up and clarify applications for Certificates of Free Sale, with practical guidance floated as a next step.

The Austrian Federal Office for Safety in Health Care (BASG) has reported on a first round table on free sale certificates for medical devices, held on 17 September 2026. Representatives of AUSTROMED, WKO, PHARMIG, the Federation of Austrian Industries (Industriellenvereinigung) and IGEPHA took part alongside the authority.

The aim was to discuss difficulties in applying for a Certificate of Free Sale (CFS) and to work out possible ways to improve the process. According to BASG, the authority and the companies concerned share an interest in processing applications as quickly as possible, but the checks needed to confirm compliance with legal requirements must still be carried out.

The medical devices market surveillance side set out the framework and procedure for issuing certificates under Regulations (EU) 2017/745 and (EU) 2017/746, and clarified which documents are reviewed during the process. Discussion centred on communication between applicants and the authority, the role of requests for improvement (Verbesserungsaufträge), and transparency about where an application stands.

As a possible next step, participants suggested developing practical aids to help applicants avoid preventable formal deficiencies and raise the quality of submissions. Other topics included handling very large applications and the option of issuing duplicates. BASG says the outcome will feed into further work on information, communication and procedures for these certificates, and that it will step up exchanges with the European Commission and other competent European authorities on the related questions.

The item describes a procedural discussion and does not state any new requirements or deadlines.

What it means for your team

  • Manufacturers and exporters that rely on Austrian CFS issuance should expect possible practical guidance aimed at reducing formal errors, though none has been published yet.
  • Applicants should note the stress on communication, requests for improvement and procedural transparency, which suggests these are the main friction points in current applications.
  • Teams submitting large applications or needing duplicates may want to follow further BASG outputs, as both topics were discussed without any stated outcome.
  • BASG says it will intensify contact with the European Commission and other national authorities, so wider alignment on CFS handling may follow.

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

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