Legal Obligations of Professional Users of Medical Devices:
In line with Article 2 of Government Emergency Ordinance no. 46/2021, “the National Agency for Medicines and Medical Devices of Romania, hereinafter referred to as the NAMMDR, is designated as the competent authority in the field of medical devices, as well as the market surveillance authority in the field of medical devices, within the meaning of the Regulation”. The NAMMDR regulatory market surveillance directorate surveys the market of medical devices and checks whether medical devices meet the requirements of the applicable technical regulations. The respective controls are carried out both at the sites of economic operators who import, trade/distribute and perform activities in the field of medical devices as well as at the sites of professional users who use devices medical.
The operational procedure for market surveillance of medical devices stipulates that checks can be unannounced, thematic and reactive.
In accordance with provisions of Article 933 of Law 95/2006, the obligations which must be observed by users of medical devices are the following:
Article 933 – (1) In order to ensure the level of security and performance appropriate to the purpose for which the medical devices are made and to avoid potential incidents, users have the obligation:
a) to use medical devices only for their intended purpose;
b) to make sure that the medical devices are used only during their shelf life, when applicable, and that they do not deviate from their functional performances and applicable security requirements;
c) to appoint a contact person with the NAMMDR, with responsibilities in maintaining records of repaired and checked medical devices in use, and to ensure a documented system of records in this regard, in line with the methodological norms in force;
d) to ensure the installation, maintenance and repair of medical devices with units approved for performing such services;
e) to inform the manufacturers and the specialised structure about any incident that occurred during use;
f) to ensure the preservation of the quality and purchase documents of the medical devices, namely the declaration of compliance and the CE marking certificate and, as the case may be, the manual or instructions for use and the purchase invoice, in order to ensure the traceability of the medical device, and to submit them upon request of the NAMMDR inspectors;
g) to set up a register of medical devices in use according to the methodological norms in force;
h) to ensure the periodic verification of the medical devices used, according to legal provisions;
i) to ensure optimal conditions for keeping and storing medical devices, in accordance with the requirements specified by the manufacturer;
j) to ensure before use that the label and instructions for use of the medical devices comply with the requirements set out in Annex I chapter III point 23 of Regulation (EU) 2017/745, namely with the requirements set out in Annex I chapter III point 20 of Regulation (EU) 2017/746 in the case of medical devices for in vitro diagnosis;
k) to ensure that they only use medical devices in the situation where, in the context of their professional activity, equipment for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease is used, as defined in Article 2 point 1- first indent of Regulation (EU) 2017/745.
(2) The medical devices found at the site of the user for clinical investigation or assessment performance in view of certification and which are subject to the requirements of the regulations or, as the case may be, to the procedure for assessment of compliance, provided for in the applicable technical regulation, are exempt from the provisions of paragraph (1).
(3) Users of medical devices must ensure that spare parts are provided for commissioned and used medical devices and that there are approved units for servicing.
Articles 934 and 935 of Law 95/2006 mention the following infringements:
Article 934 – Violation of the provisions of this title leads to disciplinary, material, civil, contraventional or criminal liability, as the case may be, according to the law.
Article 935*) – (1) The following acts classify as contraventions and are sanctioned as follows:
a) noncompliance with provisions of Article 927 (1), fined from 5000 to 10000 lei, applicable to the provider of the unapproved activity and prohibition of performing the activity until obtaining the approval mentioned in Article 926 (2);
b) noncompliance with provisions of Article 927 (5), fined from 10000 to 15000 lei and with the withdrawal of the notice mentioned in Article 926 (2);
c) noncompliance with provisions of Article 931, fined from 5000 to 10000 lei, applicable to the supplier and the healthcare unit, as well as with the prohibition of use of the medical device until being granted the approval mentioned in this title;
d) noncompliance with provisions of Article 927 (4), fined from 2000 to 5000 lei;
e) noncompliance with provisions of Article 933 (1) points b) and i), fined from 10000 to 20000 lei, as well as the ban on the use of noncompliant devices;
f) noncompliance with provisions of Article 933 (1) points a), c), e), f), g) and h), fined from 2000 to 5000 lei;
g) unjustified prevention, in any form, of the authorised persons from performing their duties provided for in this title, fined from 5000 to 10000 lei;
h) noncompliance with provisions of Article 933 (1) points d) and j), fined from 5000 to 10000 lei, as well as the ban on the use of noncompliant medical devices;
i) noncompliance with provisions of Article 927 (4), leading to performance of the activity in violation of the legal provisions or distribution of noncompliant or falsified medical devices, fined from 10000 to 20000 lei and suspension of the operation approval;
j) noncompliance with provisions of Article 933 (1) point k), fined from 5000 to 10000 lei, as well as the prohibition of the use of equipment not classified as medical devices;
k) the use by users, within their professional activity, of falsified medical devices as defined in Article 2 point 9 of Regulation (EU) 2017/745 is fined from 10000 to 20000 lei, as well as the prohibition of the use of the falsified medical devices.
(2) Repetition of the contravention provided for in paragraph (1) point a), within a 1-year period from enforcement of the sanction, is fined from 10000 to 20000 lei and the prohibition of performing the activity mentioned in Article 927 (1), until obtaining the operation approval, mentioned in Article 926 (2).
(3) Repetition of the contravention provided for in paragraph (1) point i) within a 1-year period from enforcement of the sanction, is fined from 10000 to 20000 lei and the prohibition of use of noncompliant medical devices.
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*) The provisions of Article 935, as amended through Government Ordinance no. 37/2022, enter into force on 10 September 2022 (see Article V paragraph (3) of Government Ordinance no. 37/2022)
Article 15 of Government Emergency Ordinance no. 46/2021 states the following:
Article 15 – Any type of assessment of the health and therapeutic condition, even when the values obtained as a result of the assessment are informative, regardless of whether the activity is performed in a medical office, healthcare institution, centers of complementary medicine, bioresonance cabinets or even in spaces specially arranged for outpatient activities, for which various medical devices are used, is considered to be done for medical purposes and only medical devices shall be used, in this respect.
Order no. 2219 of 14 July 2022 stipulates the following:
Article 3 –Medical devices as equipment of healthcare units and of means of intervention for pre-hospital emergency medical assistance, subject to control through periodic verification, as well as the frequency of the verifications, are provided in Annex 1.
Article 20 – Healthcare units have the following obligations:
a) to appoint a person responsible for maintaining records of medical devices in use and as a contact person in the relationship with the NAMMDR;
b) to establish a register of medical devices in use, particularly stating:
- name/type of the medical device;
- manufacturer, country of origin;
- batch/year of manufacture, inventory number;
- document of provenance;
- date of commissioning;
- records of repairs and other maintenance operations, as well as of the persons performing them;
- records of controls through periodic verification;
- involvement in potential incidents in use (date, location, description of the incident, responsible staff, corrective actions, etc.);
- internal movement within the unit (where it comes from, new place of use, date, etc.);
c) to ensure the planning for the control through periodic verification of the medical devices in use, in line with the conditions of this Order.
Article 21 – (1) The use of medical devices which do not correspond to the tests carried out during the control by periodic verification or during assessment of the performance of second-hand devices is prohibited.
(2) After deletion of noncompliances, the medical devices provided for in paragraph (1) undergo a new verification in view of issuance of a periodic check bulletin/approval for use.
(3) For noncompliance with provisions of this Order, the sanctions mentioned in Article 935 points b) – g) of Law no. 95/2006, republished, with further amendments and supplementation, shall apply.
(4) In the case of requests submitted to the NAMMDR for the purpose of issuing the periodic check bulletins or the approval for use, which have not been resolved upon entry into force of this Order, healthcare units should send the updated request to the NAMMDR in accordance with provisions of this Order, within 6 months.
Any healthcare unit (e.g., bioresonance offices, complementary medicine offices, specialty offices, dental offices, family medicine offices, hospitals, etc.), falls under the legal provisions mentioned above. The NAMMDR, as the competent authority in the field of medical devices, according to the provisions of Article 2 of Law no. 134/ 2019, handles both the surveillance of the market of medical devices and the inspection and control of medical devices in use.
Moreover, the medical devices and medical consumables included in this category, placed on the market and in use, must comply with the legal provisions regarding the assessment of product compliance, according to the applicable legal provisions.