Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, including amendments: Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market, Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
Medical Devices Act (Official Gazette, No. 76/2013)
Requirements for medical devices, clinical trials of medical devices, entry into the register of medical devices manufacturers, conformity assessment and CE markings, conformity assessment bodies, registration, placing on the market, advertising, vigilance and supervision and control of medical devices.
Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette No. 84/2013 and 126/2019)
Essential requirements for medical devices, the conditions and rules for the classification of medical devices and in vitro diagnostic medical devices, the method of registration and the documentation required for the registration in the register of manufacturers, the method of, and the documentation required for, registration of a medical device in the register of medical devices, the content and the method of submission of notification of placing a medical device on the market, the conformity assessment, the content of the declaration of conformity and the CE marking.
Ordinance on Monitoring Adverse Incidents Related to Medical Device (Official Gazette, No. 125/2013)
System of reporting and assessment of adverse incidents and safety corrective measures related to medical devices, which means the system of medical devices vigilance and activities that should be undertaken by manufacturer, manufacturer’s authorised representative or the Agency for Medicinal Products and Medical Devices when it receives an information on adverse incident related to medical devices.
1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
- eliminate or reduce risks as far as possible (inherently safe design and construction),
- where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
- inform users of the residual risks due to any shortcomings of the protection measures adopted.
3. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.
5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.
6. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.
Devices must be CE marked.
Medical Devices Act - Article 12. – language requirements
The instructions for use and labelling of the medical device must be in the Croatian language and appear in a visible and legible and form. The instructions for use of medical devices exclusively intended for use by medical institutions must be supplied in a language which is known by the user.
Ministry of Health, Agency for Medicinal Products and Medical Devices
Email: Clinical investigations: romana.katalinic@miz.hr
General contact, registration procedures, device qualification and classification, vigilance: medpro@halmed.hr
Phone: +385 1 46 07 555, +385 1 48 84 100
Web: https://zdravlje.gov.hr/, https://www.halmed.hr/en/
Ministry of Health
Email: farmaceutska.inspekcija@miz.hr
In the TRIS database you can look up the notification of the technical rule