material or parameters between an active medical device and the patient is not considered as active medical device. §2 (4) MPG “active implantable medical device” means any active medical device relying for its [...] Austrian Medical Devices Act, Medizinproduktegesetz PS performance study PE performance evaluation AIMD active implantable medical device AMG Austrian Medicines Act, Arzneimittelgesetz BASG / AGES Institute [...] /instructions for use) and the CI does not foresee additional diagnostic or therapeutic measures Caution! Active implantable medical devices (AIMD) according to Directive 90/385/EEC are exempted from §40 (5) MPG

Referenced at:

• Clinical investigations with medical devices

Supposed natural product turns out to be a counterfeit

Recall of one batch of Adolorin Ibuforte 400 mg Dragees due to reduced release of the active substance.

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

With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from intrauterine devices (IUDs) for contraception manufactured by Eurogine S.L..

Recall of active substance batches due to possible contamination with erythromycin stearate.

Recall of a batch of Fasturtec due to possible low filling volume of some vials.

Recall of one batch of Oxygerolan, because the specified active ingredient content cannot be guaranteed.

Alleged natural product contains undeclared synthetic active pharmaceutical ingredient.

Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.