In-house devices means devices that are manufactured and used within a health institution in accordance with the Medical Devices Act (ZMedPri-1), as provided in Article 5(5) of Regulation 2017/745/EU and Article 5(5) of Regulation 2017/746/EU. In-house devices are governed by Article 13 of the Medical Devices Act (ZMedPri-1).
Pursuant to Regulations 2017/745/EU and 2017/746/EU, health institution means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
The Medical Devices Act (ZMedPri-1) further defines a health institution as a healthcare provider in accordance with the Act governing health services.
Registration with the JAZMP
Health institutions that manufacture or use the in-house devices referred to in Article 13 of the Medical Devices Act (ZMedPri-1) must register with the JAZMP before commencing the manufacture or use of such devices within the health institution.
Person responsible for regulatory compliance and person responsible for vigilance
- A certificate issued by the economic operator demonstrating at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
- A copy of the contract or other relevant document.
Applications for registration must include the following:
- A completed registration form for health institutions manufacturing and using in-house devices Form 860-02 must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours. The form must be stamped and signed by the person authorised to represent the company.
Upon receiving a complete application (including the form and all mandatory attachments), the JAZMP will process it. The applicant will receive a digitally signed Certificate of Registration of the Economic Operator via the company’s general email address.
Change of economic operator data:
Health institutions must ensure that the data submitted with the registration application is accurate. They must notify the JAZMP of any changes to their data by submitting a new application – Form 860-02 no later than eight days after the change is made.
Deletion of economic operator:
- Deletion form: Form 861-03
The completed, signed, and stamped form must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours.
Health institutions must confirm the accuracy of the data referred to in paragraph two of Article 18 of the Medical Devices Act (ZMedPri-1) annually by the deadline specified deadline, which must be at least 30 days after the request is made. If they fail to do so, the JAZMP will initiate the procedure for deletion from the register 30 days after the deadline for confirming data accuracy has expired.
