H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Medical devices

Our Role

OGYEI is the Hungarian Competent Authority for medical devices and in vitro medical devices. The Competent Authority is authorised to act on behalf of the Hungarian government of the member state to ensure that the requirements of the Medical Device Ragulations are applied.

OGYEI is also the Designating Authority of the Hungarian notified bodies which can certify medical devices. The Designating Authority is a body which has the authorisation to designate and controll the notified bodies located in Hungary.

Our aim is to make sure that medical devices are as safe as possible and that they work as intended.

Registration under MDR

From 26 May 2021, economic operators placing class I medical devices on the market must be in compliance with Regulation (EU) 2017/745 on medical devices (MDR). This means that from 26 May 2021, any class I medical devices, CE marked in accordance with Directive 93/42/EEC, can no longer be placed on the market. Exceptions include those class I devices that fall within the scope of Article 120 of the MDR, such as class I devices with a valid notified body certificate under the Directives or devices up-classified under the MDR.

Any registrations made to the OGYÉI under the Directive 93/42/EC on medical devices (MDD) and Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD) do not qualify as registration obligations under the regulations (MDR/ IVDR).

If you are placing devices on the market under the Regulations you must follow the registration steps to register under the MDR/IVDR registration.

Information on the registration of economic operators and devices in accordance with the obligations set out in the MDR/IVDR.

Who?

Where?

When?

How?

Manufacturer

Authorised representative

Importer

System & Procedure Pack Producer

EUDAMED ACTOR module*

From December 2020

Mandatory from 17. August 2021

Online - EUDAMED

Device (for manufacturers)

temporarily national database

 

then EUDAMED Device/UDI module

From 26. May 2021

 

 

Form available on OGYÉI's website

Custom Made Manufacturer

 

national medical device register (called NOR)

From 26. May 2021

Form available on OGYÉI's website

Economic operators (distributors, importers)*

NOR*

Registration is mandatory from 17. August 2021*

Form available on OGYÉI's website

*Scroll down for more information.

Definitions

Manufacturer

(i) a person who is responsible for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person himself or herself or on his or her behalf by a third party, or

(ii) a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a medical device with a view to their being placed on the market under his or her own name, but not including a person who assembles or adapts medical devices already on the market to their intended purpose for an individual patient, or

And/or has the meaning assigned to it by-

(i) Article 2(30) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or

(ii) Article 2(23) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017.

 

Authorised representative: An authorised representative means any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations/Directives.

Importer: An importer is defined as any natural or legal person established in the EU that places a device from a third country on the EU market.

‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

System & Procedure Pack Producer: The same obligations apply as a manufacturer. Under the MDR, entities placing system and procedure packs on the market are called ‘system and procedure pack producers’.

Custom Made Manufacturer

An organisation that makes medical devices which are ‘custom-made devices’ means any device specifically made in accordance with a written prescription of any person authorised by national law. The device is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. A custom made device manufacturer is required to register via Eudamed if they manufacturer custom made class III or implantable devices, and directly on the national OGYÉI register (called NOR) if they manufacturer class I, class IIa and class IIb custom-made medical devices.

 

Information for EUDAMED ACTOR registration:

According to 4/2009 EüM Decree from 17. August 2021 it is obligatory for Manufacturers, Importers, Authorised representatives, System & Procedure Pack Producer register using the registration module of Eudamed.

To complete a registration on Eudamed:

For more information: https://ogyei.gov.hu/eudamed_actor_modul

If you have any question, please feel free to contact us.

Economic operators (distributor, importer) registrations obligations:

A distributors, importers (authorised representatives if they market medical devices) are required to register on the national OGYÉI register (called NOR).

Registration requirements for MD/IVD distributors after the date of application of the MDR (26.05.2021):

Distributors (domiciled in Hungary), who want to sell medical devices in Hungary, must register with the OGYEI (Hungarian Competent Authority for Medical Devices) to the national medical device register (called NOR).

Registration steps for distributors domiciled in Hungary:

- Complete and submit the application form (can be downloded from here (only Hungarian): https://ogyei.gov.hu/forgalmazoi_regisztracio )

- Provide a list of the devices (including Basic UDI-DI)

- The EU declaration of conformity and CE certificate (when applicable) of the products must be submitted. (Please note that legacy device does not need to be registered)

- Instructions for use and label (Hungarian and when applicable in English as well)

Procedure fee must also be paid for the registration.

If you have compiled the documents required for registration, we recommend that you send them to amd@ogyei.gov.hu or in case of IVD to ivd@ogyei.gov.hu for prior consultation.

Registration is mandatory from 2021. 08. 17 according to article 17. of 4/2009 Ministerial Decree.

Distributors (not domiciled in Hungary)

We recommend that distributors who are not established in Hungary inquire about their obligation to registration obligation with the competent authority of their Member State.

Please note that in Hungary, certain medical devices are also considered medical aids („gyógyászati segédeszköz”). As a medical aid, it may only be sold to the lay end user from a pharmacy or a licensed specialty store for medical aids (holding an operating license issued by the public health administration).

As Hungary is one of the member states of the European Union, the relevant EU harmonised requirements for these kind of products are the same in Hungary (MDD, AIMD, MDR, IVDD, IVDR). This means that if the conformity assessment procedure applicable for the device in question have alrady been conducted in any other EU country, the device can be freely marketed in Hungary as well.

The essential requirements (e.g. language requirements, etc.) should be fulfilled according to the relevant Hungarian decree.

If the product is available on the Hungarian market, the IFU and label of medical devices and IVD medical devices must be available in Hungarian.

Language requirements:

Regulations

2017/745/EU

2017/746/EU

Language(s):

Hungarian

Hungarian

Directives

93/42/EEC

90/385/EEC

98/79/EC

Language(s):

Hungarian

Hungarian

Hungarian

 

Software - display

The information that appears on the display as a symbol, a pictogram, graphic illustration or a kind of short text in foreign language is acceptable, provided that the meaning of them are unambiguously explained by clear illustrative drawings and related Hungarian explanatory text in the instructions for use.

In general the user interface of the software must be available to the user in Hungarian (except standardized pictograms) as this is necessary for safe and proper use, regardless of whether the device is for professional or other (lay) use.

This only apply for software – display: The software user interface is accepted in English as well, however, in such cases, the user interface is required to be explained in detail using “screenshots” in the user manual which is provided in the national language (Hungarian). However, this can also have a reasonable limitation, mostly depending on how complex the user interface is.

- If it is extremely simple, it can be acceptable to ensure proper and safe use with the solution detailed above.

- If the software displays more complex, larger amounts of information in text on the user interface, it is probably inevitable to issue a Hungarian language patch.

It may be appropriate for the manufacturer to make a decision on this through a risk analysis. The manufacturer's responsibility in unexpected event (vigilance) must be taken into account if the subsequent investigation reveals that its occurrence is due to or has contributed to errors in the user's interpretation of the text in the IFU/label or on the display (software).

Although English is conventionally used for the international communication of the medical professional language,cannot be expected from service providers to have a certified and employer-accepted language proficiency in any language other than Hungarian.

Medical aid (gyógyászati segédeszköz)

Definition of ’medical aids’:

Medical aid shall mean any medical device made available for personal use to patients suffering in a temporary or persistent health impairment or disability (including IVD devices for self-testing purposes), and other technical devices for nursing and caring purposes, which are not treated as medical devices, designed for use without the continued presence of a healthcare professional.

According to 7/2004 (XI.23) EüM decree ’Medical aids’ could be distributed only via pharmacies and special shops for medical aids (with operating licence).

According to Article 3. (5) of 2/2008 (II.8) EüM decree in vitro diagnostics (rapid tests) for the diagnosis of HIV and Hepatitis (B, C and D) can only be distributed by Institutional pharmacy and only for in-patient use.

In these cases, it must be ensured that the user / patient can ask questions about the device and receive an appropriate professional answer.

There are two possibilities during the advertising activity:

- 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.

- 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.

Designating Authority:

Before a manufacturer can market a sterile class I. medical device or a class I. medical device with measuring function or Class I reusable surgical instruments or any Class IIa, IIb, and III. medical device, they must follow a conformity assessment procedure to document that the product conforms to the legal requirements for medical devices.

In Hungary there are two notified bodies which can certify these products: OGYEI-EMKI (NB 1011) and CE Certiso Kft. (NB 2409). The NB assess whether the manufacturer's documentation meets the legal requirements.

Vigilance:

Reporting any incidents regarding medical devices and any safety-related corrective actions is required as it is written in the directives and regulations.

Manufacturers and distributors or users incident report forms are available on our website: https://ogyei.gov.hu/varatlan_esemeny_jelentes

For manufacturers the reporting is the same as the NEW MIR form published under MEDDEV 2.12 Post-Market surveillance:

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_guidance_meddevs.pdf

E-mail: amd.vig@ogyei.gov.hu for vigilance cases.

Free sales certificate:

OGYEI issues Free Sales certificate to manufacturers of medical devices who are headquartered in Hungary and haveregistered as manufacturers in Hungary.

Clinical investigation:

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.

A clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device.

The Medical Device Regulation2017/745(MDR) became fully applicable on 26 May 2021. This brought about a number of changes with respect to clinical investigations.

One important change with respect to the MDR is that there are a number of different types of clinical investigations specifically described within the legislation, including:

  • Pre-market clinical investigations, i.e. clinical investigations of devices without a CE mark (see Article 62 of the MDR).
  • Post-market clinical investigations, i.e. post-market clinical follow-up (PMCF) investigations (see Article 74 of the MDR, which may apply).
  • Clinical Investigations undertaken for purposes other than those listed in Article 62 of the MDR (see Article 82 of the MDR).

For application please use the documents of MDCG 2021-08 guide, the application can be sent by documentation transfer system of OGYÉI: https://transfer.ogyei.gov.hu/verify.php

(info about OGYÉI transfer service: https://transfer.ogyei.gov.hu/changelocale.php )

Serious Adverse Event Reporting:

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 OGYÉI expects all sponsors to follow this guidance.

The MDR provides transitional provisions for studies that are ongoing with respect to the Directives (i.e. studies that have started to be conducted prior to 26 May 2021). These investigations may continue to be conducted after the date of application of the MDR, but the reporting of SAE and device deficiencies shall be carried out in accordance with the MDR requirements from 26 May 2021. The new reporting requirements apply prospectively to SAE and Device deficiencies that happen after 26 May 2021. Sponsors do not need to retrospectively verify if adverse events that occurred before 26 May 2021 meet the new MDR SAE definition.

Research Ethics Committees and Clinical Investigations:

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

For more information: https://ogyei.gov.hu/klinikai_vizsgalatok_orvostechnika

If you have any question please contact Medical Devices Department: amd@ogyei.gov.hu

Market surveillance:

OGYEI as a Competent Authority is responsible for the controll of the market of medical devices and in vitro medical devices.

Where we identify a significant safety or quality concern with a device, there are a range of regulatory actions we can take to protect public health. These includes are i.e. changes to labelling, safety notices or recalling the product from the market.

The table available at the link below lists the products restricted in distribution and sanctioned economic operators: https://ogyei.gov.hu/Forgalmazasban_korlatozott_termekek

Contacts of department of Medical devices:

Phone: +36 (1)886 9329

E-mail

Questions regarding medical devices

amd@ogyei.gov.hu

E-mail of vigilance cases

amd.vig@ogyei.gov.hu

Questions regarding in vitro medical devices

ivd@ogyei.gov.hu

 

Address: 1051 Budapest, Zrínyi u. 3, Hungary

 

Last updated: 2021.10.06 13:01