The Romanian implementation laws of the MDR (Emergency Ordinance no. 46 of 9 June 2021) and of IVDR (Emergency Ordinance no 137 of 12 October 2022) establish the regulatory framework, administrative mechanisms and instruments for the effective implementation of MDR and IVDR in Romania. They also provide clear language requirements to ensure proper understanding of medical device and in-vitro diagnostic medical device information by all users.
Romanian national authority
The National Agency for Medicines and Medical Devices of Romania (NAMMDR, ANMDMR in Romanian) serves as the designated competent authority for medical devices and in-vitro diagnostic medical devices.
It is also tasked with market surveillance responsibilities in this sector, ensuring compliance with the provisions of MDR and IVDR. According to Article 9 and 7 of the Emergency Ordinance n. 46 (for medical devices) and n. 137 (for in-vitro medical devices) respectively, NAMMDR processes all the serious incidents reports, and the corrective actions related to field safety reports in Romania.
Moreover, the NAMMDR is responsible to evaluate and approve advertising materials for medical devices and IVDs. Detailed provisions can be found in Article 19-25 of the Emergency Ordinance n.46. Among others, it is only allowed for the manufacturers to advertise to the general public medical devices that can be used by users without the need of a professional.
Registration of medical devices in Romania
Manufacturers or their authorised representatives based in Romania are required to register the devices with the NAMMDR. The registration requirement applies to the following categories of medical devices:
- Class I, IIa, IIb, and III devices, including sterile and measuring devices.
- Systems and procedure packs referred to in MDR Article 22.
- Custom-made active implantable medical devices.
For the purpose of the above registration, NAMMDR has published a notification form which has to be used.
This obligation derives Article 13 of the Romanian implementation law and Article 6 of Order of the Minister of Health no. 3539/2022, which approves the Methodological Rules for introducing medical devices on the market and registering economic operators in the European database on medical devices (EUDAMED) and the national database.
Romanian national language requirements
Article 3 of the Emergency Ordinance no 46/11.06.2021 (for medical devices) and Article 3 of the Emergency Ordinance no 137/2022 (for in-vitro medical devices), prescribe national language requirements for the Romanian territory. These requirements apply to the information accompanying medical devices and in-vitro medical devices, user interfaces, communication with authorities, and safety notifications.
Language of information accompanying medical devices
All information provided by manufacturers alongside medical devices and in-vitro medical devices for lay users must be available in Romanian. This ensures accessibility for Romanian users while allowing manufacturers to include translations in other official EU languages if desired.
For medical devices and in-vitro medical devices intended exclusively for healthcare professionals, this information may, for limited period and under well-justified circumstances, be provided in English. This exception applies only if the following conditions are met:
- The healthcare professionals using the device provide their written consent.
- The National Agency for Medicines and Medical Devices of Romania (NAMMDR) issues an opinion supporting this approach.
The procedural norms for implementing this provision are provided in the Minister of Health Order (MHO) no 3539/09.12.2022, Chapter V, Article 11 for medical devices, and in Ministry of Health Order no 3753/2023, Chapter V, Article 11 for in-vitro medical devices.
Language requirements for user interfaces
The user interface of medical and in-vitro medical equipment must meet specific language requirements based on the target user group:
- For equipment intended for healthcare professionals, the interface may, under justified circumstances, be provided in English. This requires the written consent of the user.
- For equipment intended for non-specialist users, the interface must be in Romanian to ensure ease of use and understanding.
Documentation submitted for conformity assessments
Upon request by ANMDMR manufacturers or authorised representatives must provide all necessary documentation to show conformity of the device The language requirements for these submissions vary depending on the manufacturer’s location:
- Romanian-based manufacturers must submit documentation in Romanian.
- Manufacturers based outside Romania may submit documentation in English, provided it is also translated into Romanian. For IVD manufacturer, this is possible if the competent authority approves it.
The EU Declaration of Conformity must be available in either Romanian or English.
Language of field safety notifications
Field safety notifications must be drafted in both Romanian and English. These notifications should be made available promptly to users of the affected medical devices and in-vitro medical devices.
For devices used exclusively by healthcare professionals, there is an exception: upon their request, field safety notifications may be provided in English only.
Reprocessing of single-use devices in Romania
Romania does not authorise reprocessing of single-use devices on its territory and has not (yet) implemented national rules to allow it.
Romania, along with 19 other EU and EEA countries, has not adopted national legislation permitting the reprocessing of single-use devices (SUDs). As a result, reprocessing SUDs is not allowed within its territory. This aligns with Article 17 of Regulation (EU) 2017/745 (MDR), which requires explicit national authorisation for such practices.
Administrative offences and penalties
Article 28 of Emergency Ordinance no 46 (MDR implementation law) outlines various administrative offenses related to non-compliance with regulatory obligations by manufacturers, importers, distributors, and healthcare institutions, while Article 29 specifies the corresponding sanctions, including fines, market withdrawal, and usage bans for non-compliant medical devices.
Article 17 of Emergency Ordinance 137 outlines administrative offenses related to in vitro diagnostic medical devices (IVDs).
Penalties, both for medical devices and in-vitro medical devices apply unless the acts qualify as criminal offenses.
You can consult analysis of other national laws in our RA Map.
References:
Government of Romania. (2023). Ordonanța de urgență nr. 46/2023 privind unele măsuri pentru asigurarea medicamentelor esențiale în România. Monitorul Oficial al României. Retrieved on 18/02/2025.
Government of Romania. (2022). Ordonanța de urgență nr. 137/2022 privind unele măsuri referitoare la autorizarea, fabricarea și comercializarea medicamentelor de uz uman. Monitorul Oficial al României. Retrieved on 18/02/2025.
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