The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.

Up-to-date information from the 24.03.-27.03.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that a confirmed autochthonous case of chikungunya has been recorded in the overseas department of Mayotte.

Up-to-date information from the 24.02.-27.02.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to possible contamination with glass splinters

Precautionary batch recall, as there may be glass splinters in the 60 ml bottles

Recall due to deviations from the specified values regarding resuspendability

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous dengue cases have been recorded in the French overseas territories: Guadeloupe, Martinique, Saint-Martin, Saint-Barthélemy, French Guiana and French Polynesia.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International - Aarhus ApS that one of the offspring of the sperm donor Bjarke has been diagnosed with Usher syndrome. The donor/gametes have been permanently blocked.