In vitro diagnostic medical devices

 

 

National legislation

Medical Devices Act (Official Gazette, No. 76/2013)

Scope of application

Requirements for medical devices, entry into the register of medical devices manufacturers, conformity assessment and CE markings, conformity assessment bodies, registration, placing on the market, advertising.
 

National legislation

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 DevicesOfficial Gazette, No. 84/2013 and 126/2019

Scope of application

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.

 

National legislation

Ordinance on Monitoring Adverse Incidents Related to Medical Device (Official Gazette, No. 125/2013

Scope of application

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.

 

Main requirements that the business user needs to know about

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, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be 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 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 be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1(2)(b), as specified by the manufacturer, taking account of the generally acknowledged state of the art. They must achieve the performances, in particular, where appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer.

4. The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order.

5. The characteristics and performances referred to in sections 1 and 3 must not be adversely affected to such a degree that the health or the safety of the patient or the user 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. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device.

6. 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 under storage and transport conditions (temperature, humidity, etc.) taking account of the instructions and information provided by the manufacturer.

Devices must be CE marked.

 

National action

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.

 

Competent authority

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/



Market Surveillance Authority

Ministry of Health
Email: farmaceutska.inspekcija@miz.hr

 

 

Link to the TRIS database

In the TRIS database you can look up the notification of the technical rule