Reporting incidents due to medical devices.

SC Revora Topmedas S.R.L - authorized holder of the domain: www.revoramedical.ro sells medical devices classes I, IIa, IIb and III through the authorization of the National Agency of Medicines and Medical Devices.

The incident due to medical devices can be:

a) any malfunction or damage to the characteristics and/or performance of a device, as well as any case of inadequacy of labeling or instructions for use, which may lead or have led to the death or severe deterioration of a patient's health or user;
b) any technical or medical cause related to the characteristics or performance of a device, which, for the reasons mentioned in letter a), leads to the systematic withdrawal from the market by the manufacturer of devices of the same type.


SC Revora Topmedas S.R.L is obliged by law to report any incident within 24 hours to the manufacturer, ANMDM, together with the analysis and report of the incident, following which corrective measures should be ordered as soon as possible until the batch in question is withdrawn.

The consumer/user who notices an incident due to medical devices, regardless of its origin, has the obligation to report this incident by:

1) Email: revoratop@gmail.com

2) Completing the USER MEDICAL DEVICE REPORTING FORM by accessing the link: https://www.anm.ro/?s=raportare+incidente

3) Phone: +40 729 466 462


More information about the legislation in the field and the reporting of incidents due to medical devices can be found below or on the ANMDM website, by accessing the link:

https://www.anm.ro/dispozitivo-medicale/vigilenta/

GD no. 54 / 2009, art. IV: VIGILANCE. INFORMATION REGARDING INCIDENTS DUE TO DEVICES INTRODUCED ON THE MARKET

(1) ANMDM ensures, centrally, the registration and evaluation of any information that is received under the conditions of this decision and that concerns the reporting of one of the following incidents in connection with medical devices of classes I, IIa, IIb and III:

a) any malfunction or damage to the characteristics and/or performance of a device, as well as any case of inadequacy of labeling or instructions for use, which may lead or have led to the death or severe deterioration of a patient's health or user;
b) any technical or medical cause related to the characteristics or performance of a device, which, for the reasons mentioned in letter a), leads to the systematic withdrawal from the market by the manufacturer of devices of the same type.
(2) The obligation to notify ANMDM regarding the incidents mentioned in para. (1) belongs to the medical staff, health facilities and the manufacturer.

(3) If the information about the incidents mentioned in para. (1) was transmitted by medical personnel, health facilities or other users, ANMDM informs the manufacturer of the device in question or its authorized representative regarding the incident.

(4) After carrying out an evaluation, if possible, together with the manufacturer or his authorized representative, in compliance with the provisions of art. 14, ANMDM immediately informs the European Commission and the other member states of the European Union regarding the measures that have been taken or are being considered to minimize the risk of reproducing the incidents mentioned in paragraph. (1), including information about the underlying incidents.

HG no. 798/2003, sect. 2: THE OBLIGATION OF VIGILANCE

ART. 34

ANMDM takes the necessary measures to ensure that all information brought to its attention, in accordance with the provisions of this decision, regarding the incidents mentioned below and involving devices bearing the CE mark are recorded and evaluated:

a) any malfunction or any alteration/depreciation of the characteristics and/or performances of a medical device for in vitro diagnosis, as well as any inadequate labelling, prospectus or instructions, likely to produce or have produced, directly or indirectly, the death or severe alteration of the state of health of a patient or user;
b) any technical or medical argument regarding the characteristics or performance of a device referred to in letter a) and which would lead to a systematic withdrawal from the market by the manufacturer of devices of the same type.
ART. 35

(1) The obligation to notify ANMDM about incidents in the use of devices, provided for in art. 34, belongs to the medical personnel, medical-sanitary institutions, other users, organizers of external quality assessment programs, the manufacturer or its authorized representative established in Romania.

(2) ANMDM informs the manufacturer or its authorized representative about any reported incident.