ARTICLE IV OF GOVERNMENT DECISION NO. 54 / 2009: VIGILANCE. INFORMATION ON INCIDENTS OCCURING FOLLOWING PLACING OF DEVICES ON THE MARKET
(1) The NAMMD ensures that any information brought to their knowledge, in accordance with the provisions of this Decision, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:
(a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (1), leading to systematic recall of devices of the same type by the manufacturer.
(2) The responsibility for informing the NAMMD of any incidents referred to in subparagraph (1) lies with healthcare professionals, medical institutions or the manufacturers of the devices concerned, or their authorised representative.
(3) Where information on the incidents referred to in subparagraph (1) has been transmitted by healthcare professionals, healthcare facilities or by other users, the NAMMD shall inform the manufacturer of the device concerned or their authorised representative of the incident.
(4) Following assessment together with the manufacturer or their authorised representative, if possible, pursuant to provisions of Article 14, the NAMMD shall inform all Member States and the Commission relating to measures taken or envisaged to minimize the risk of duplication of the incidents referred to in subparagraph (1), including information on the underlying incidents.
SECTION 2 OF GOVERNMENT DECISION NO. 798/2003: VIGILANCE OBLIGATION
ARTICLE 34
NAMMD shall take all necessary measures to ensure that all information brought to its knowledge, in accordance with provisions of this Decision, regarding incidents listed below and involving devices bearing the CE marking are recorded and evaluated:
(a) any malfunction or any alteration / impairment in the characteristics and / or performance of an in-vitro diagnostic medical device as well as any inadequate labeling, user leaflet or instruction likely to produce, or have produced, directly or indirectly, death or severe damage to the health of a patient or user;
(b) any technical or medical reason in relation to the characteristics or performance of a device for reasons referred to in point a) leading to systematic recall from the market of devices of the same type by the manufacturer.
ARTICLE 35
(1) The responsibility for informing the NAMMD of any incidents occurring in use of devices referred to in Article 34 lies with healthcare professionals, medical institutions, other users, organisers of external quality assessment programmes, manufacturers of the devices concerned or their authorised representative established in Romania.
(2) Following assessment together with the manufacturer or their authorised representative, if possible, without prejudice to provisions of Article 14, the NAMMD shall inform all Member States and the Commission relating to incidents provided for in Article 34, in relations to which adequate measures have been taken or envisaged, recall included.
ARTICLE 37
(1) Where a device bearing the CE marking, reported by notification such as that provided for in Section 1 of this Chapter, is a new product, the manufacturer shall state this in their notification.
(2) Thus notified, the NAMMD may request the manufacturer, within the next 2 years and for justified reasons, to submit a report on post-marketing experience with the respective device.
ARTICLE 38
Upon request, the NAMMD shall inform competent authorities of all Member States and the Commission relating to matters referred to in Art. 34 – 37 and establish the procedures for application of this section provisions.
CHAPTER IV OF GOVERNMENT DECISION NO. 55/2009: VIGILANCE. INFORMATION ON INCIDENTS RISING FROM DEVICES PLACED ON THE MARKET:
ARTICLE 13
(1) The NAMMD ensures that any information brought to their knowledge regarding the incidents mentioned below involving medical devices is recorded and evaluated centrally:
(a) any malfunction or deterioration in the characteristics and performance of a device, and any inappropriate labeling or instructions which may lead to or have led to the death or serious deterioration of a patient or user’s health;
(b) any technical or medical reason relating to the characteristics or performance of a device for reasons referred to in point a) leading to systematic recall from the market of devices of the same type by the manufacturer
(2) The responsibility for informing the NAMMD of any incidents occurring in use of devices referred to in Article 34 lies with manufacturers of the devices concerned or their authorised representative, importers, distributors, healthcare professionals, medical institutions or other users.
(3) Where information on the incidents referred to in subparagraph (1) has been transmitted by healthcare professionals, healthcare facilities or by other users, the NAMMD shall inform the manufacturer of the device concerned or their authorised representative of the incident.
(4) Following assessment together with the manufacturer or their authorised representative, if possible, without prejudice to provisions of Article 12, the NAMMD shall forthwith inform all Member States and the Commission relating to measures taken or envisaged to minimize the risk of duplication of the incidents referred to in subparagraph (1), including information on the underlying incidents.

Applicable guidelines
MEDDEV 2.12-1, rev 8 – GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
FORMS:
– Incident Report (prepared by the manufacturer);
– Corrective Action Report on Safety in Operation (prepared by the FSCA producer);
– Warning Notice (FSN)
– Periodic Report (PSR);
– General Report (prepared by the manufacturer)