Medical devices (1)

 

EU legislation

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable 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

 

National legislation

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

Scope of application

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.

 

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 Devices (Official 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 implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons.
  2. The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured 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 him.
  3. The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.
  4. The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.).
  5. Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended.

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