Medical device safety information

Medical Devices

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.

List of medical devices for sale out of pharmacies and specialised outlets for retail of medical devices

22.07.2013

According to the Art. 49 of the Medical Devices Act (Official Gazette, No 16/13), the Agency for Medicinal Products and Medical Devices is adopting a list of medical devices that may be sold out of pharmacy and specialised outlet for retail of medical devices. According to the Art. 47 of the Medical Devices Act, legal and natural persons executing a wholesale of medical devices from this list do not need to be entered into the registry of medical device wholesalers.
You may find the list under the following link.

Information about the precautionary recall of Paradigm reservoirs and safety information about Paradigm infusion sets

11.07.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has received an information from the holder of the enrolment into the medical device registry, Oktal Pharma d.o.o., Zagreb and retrospectively the information from the manufacturer’ representative, Medtronic B.V./Adriatic Region Zagreb about the corrective measures related to the Paradigm infusion sets manufactured by Medtronic MiniMed, USA.
The holder of the entering into the medical device registry, Oktal Pharma d.o.o., Zagreb, has in collaboration with the manufacturer’s representative Medtronic B.V./Adrioatic Region, Zagreb and manufacturer, Medtronic MiniMed, USA, initiated two corrective safety measures resulting in a preventive recall of certain lots of the medical device Paradigm reservoirs with lot numbers MMT326A and MMT-332A and providing further information and advice to healthcare professionals and users of the Paradigm infusion sets about the possibility of under- or over-delivery of insulin or other liquids coming in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector.
You may find detailed information under the following link.

Volontary recall of the medical device OneTouch Verio®Pro – glycaemic self-management system intended for home and ambulatory care, manufactured by LifeScanEurope

19.03.2013

The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro – glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope – Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
Hereby we inform all users to stop using the product OneTouch®Pro – glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro – glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.
Further information is available in the continuation of this information.

Information to holders of the medical device registration about the changes related to Croatia’s accession to the EU

03.01.2013

The Agency for Medicinal Products and Medical Devices (HALMED) informs all the holders of the medical device registration, that from 1 June 2013, HALMED will cease to accept applications for registration of medical device manufacturers from legal entities in the Republic of Croatia who represent manufacturers with headquarters in the EU or EEA, as well as manufacturers with headquarters outside the EU or EEA territory, that already have an authorised representative in the EU/EEA. More so, HALMED will cease to accept applications for notification of the risk class I of medical devices into the registry.

Medical Devices