1. What is the purpose of periodic inspection of medical devices?
All healthcare providers in Hungary, including those defined as healthcare providers according to Act CLIV of 1997 on health care (referred to as the “Healthcare Act”), have a mandatory responsibility to regularly examine their high-risk medical devices.
This examination aims to furnish comprehensive insights into any wear and tear experienced by the medical devices during usage, any alterations in the device documentation specifications, and the ongoing suitability and safe functioning of these devices. Consequently, functional assessments and electrical safety assessments are conducted on these devices during their routine inspections. This legal obligation for healthcare providers is stipulated in Decree 4/2019 of the Ministry of Health concerning medical devices.
2. Which medical devices must be inspected and at what intervals?
| Type of instrument* | Frequency of review |
| Dental treatment unit, defibrillator, surgical cutting and ablation equipment, incubator, ventilator, dialysis equipment, invasive and interventional equipment, anaesthesia machine. | 1 year |
| X-ray, fluoroscopy, dental x-ray, surgical image intensifier, surgical and guarding monitor, laser, invasive blood pressure and blood flow meters, machine infusion dispenser, flexible endoscopes/endoscopes and their image display and storage systems, ECG, haemodynamic recording equipment, coronary pressure and flow measurement system, electrophysiological measuring and recording equipment. | 2 year |
| Surgical lamp - ceiling/surgical lamp, examination lamp, operating table, electrically operated hospital beds, blood warming equipment, sterilisation equipment, mains operated electrotherapy equipment, medical gas supply equipment and complete systems, ultrasound diagnostic equipment. | 3 year |
*= Annex 13 of Decree of Ministry of Health No. 4/2009.
The review must be carried out regularly every one, two or three years, depending on the type of device. The inspection year shall be calculated from the date of entry into service of the particular device. For new groups of devices introduced on 26 May 2023, the review shall start immediately.
3. Who can carry out the review?
Periodic reviews may only be carried out by authorised organisations with a valid decision issued by the National Center for Public Health and Pharmacy (NCPHP) A list of these organisations is available on the NCPHP website: https://ogyei.gov.hu/idoszakos_felulvizsgalat/
4. What are the legal consequences if the healthcare provider does not comply with the review?
If a healthcare provider neglects to conduct a regular assessment of a group of devices that require periodic review due to their own fault or negligence, the NCPHP has the authority to issue a warning to the healthcare provider following a potential administrative inspection. Furthermore, the NNGYK (former OGYÉI) may also impose fines on the healthcare provider, in addition to promptly notifying the licensing authorities in charge.
5. For how long must inspection documents be kept and by whom?
Records of periodic inspections are drawn up and must be kept at least until the start of the next periodic inspection to allow for the review and verification of any errors detected and their correction. The documentation must be kept by the end-user's (i.e., the health service's) instrument supervisor and presented on request to the NCPHP and, where appropriate, to the occupational safety and health inspectorate, the supervisory body, or the public health administration.
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Sources:
- Decree 4/2009 of the Ministry of Health on medical devices
- General Information on periodic inspection of medical devices by NCPHP Link: https://ogyei.gov.hu/altalanos_tajekoztato …
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