Medical Devices

Medical device safety information

The manufacturer or authorised representative of the manufacturer of a medical device must notify the Agency for Medicinal Products and Medical Devices in writing of any corrective action it intends to carry out in order to reduce as far as possible the possibility of a recurrence of an adverse incident concerning the medical device.

In addition to notifying the Agency, the manufacturer or authorised representative of the manufacturer of a medical device must notify users about the corrective action by providing safety information using a method that guarantees that all users are notified. The safety information should be in Croatian language and include the elements set out in Annex III of the Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13).

We present received safety information notifications below.

Temporary suspension of use of the implants produced by the Brasilian manufacturer Silimed

25.09.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has recommended a temporary suspension of implantation of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has been discontinued in the Republic of Croatia. The suspension has been due to precautions after an unannounced inspection at the manufacturing site in Brasil discovered a impurity with particles on the surface of certain products of this manufacturer. According to the currently available safety data there are no indications that this issue could have a harmful effect on the health of patients with these implants.

Therefore, individuals with these implants are for now advised not to take any further steps than ordinary ones and regular controls according to doctor’s recommendations. In the case of concern patients should speak to their doctor who implanted the product.

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