Medical Device Regulatory Requirements in Hungary

Regulatory Authority National Institute of Pharmacy and Nutrition
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations EUMDR-2017/745 | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations (EU) 2017/745 | Click Here
Registration Process Device Registration | Click Here
Registration Timeline For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product
Requirement of Authorized Representative Yes
Language Requirement Labels must be in Hungarian Language
Clinical Trials Information

OGYEI can grant permission for the use of medical devices bearing or not yet bearing the CE marking in clinical examination if performed in Hungary.

In general, clinical investigations of investigational medical devices require two types of assessment, from a National Competent Authority for medical devices (NNGYK) and from a relevant Research Ethics Committee (ETT-TUKEB), prior to beginning the study.

| Click Here
Database EUDAMEDOGYEI | Click Here
Declaration of Conformity
Article 19: EU declaration of conformity
 
The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered.
Certificate of Free Sale

OGYEI issues Free Sales certificate to manufacturers of medical devices who are headquartered in Hungary and have registered as manufacturers in Hungary.
Post Market Surveillance

Event of death or an unanticipated serious deterioration in a person's state of health- Immidiately, but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.

Serious public health threat- immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
Reportable Incidents

The European Commission has published guidance on the reporting of serious adverse events (SAE) and device deficiency (MDCG 2020 10/1 Safety Reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745) and the NNGYK expects all sponsors to follow this guidance.
Adverse Event Reporting Form Download
Advertising and Promotions

There are two possibilities during the advertising activity:

  1. Medical aids may not be advertised to the general public if they can be dispensed from the pharmacy solely with a prescription or which are approved for social security subsidies subsidized under the social security system. Outside the provisions of Act XCVIII of 2006, it is prohibited to engage in any activity for the promotion or sponsorship of any medicinal products or medical aids which may be prescribed at a price with a social security subsidy.
  2. If it is not a device that can be purchased with social security benefits and qualifies as a medical aid, advertising is permitted. During the advertising activity, it is mandatory to draw the attention of the user/patient to read the instructions for use and consult a doctor (or healthcare professional) if they have any questions.
Additional Information

A distributors, importers (authorised representatives if they market medical devices) are required to register on the national OGYEI
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 24/Jun/2025

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