Procedure for communication of a risk event and forms of notification

The Regulation established the procedure for communication of risk events associated with a medical device and forms of notification with a purpose to decrease the likelihood of repeated occurrence of similar risk events.

The provisions of the Administrative Procedure Act shall be applied to the administrative procedure provided in the present Regulation, considering the differences in the present Regulation.

(1) In the event of the occurrence of a risk event, a health care provider shall submit a notice to the Health Board according to the form provided in Annex 1 to the present Regulation.

(2) In the event of the occurrence of a risk event, a manufacturer or an authorised representative thereof shall submit a notice to the Health Board according to the form provided in Annex 2 to the present Regulation.

(3) Upon being informed of a dangerous medical device, a distributor of the medical device shall immediately submit a written notice to the Health Board, including the following information

1) name and address of the person submitting the notice;

2) identification of the medical device (name of the manufacturer of the device, commercial name, model and type of the device, serial and/or lot number of the device, type and software version, if applicable);

3) class of the medical device;

4) description of the risk based on the medical device.

(4) Upon learning of a risk event, a distributor of a medical device shall immediately submit a notice to the Health Board according to the form provided in Annex 2.

(5) The notice described in sections 1, 2, 3 and 4 may be submitted in writing or electronically. The person submitting the notice shall sign it.

(6) The manufacturer of the medical device or an authorised representative thereof shall inform the Health Board immediately of a risk event, but not later than

1) within two days if there is a serious risk to the health of people;

2) within ten days if an event has occurred that caused or could cause the death or health disorder of a patient, operator of the device or a third person;

3) within 30 days if an event associated with the device has reoccurred, and upon the reoccurrence thereof it can lead to the death or serious health disorder of a patient, operator of the device or a third person, or if it becomes evident that the information provided in the user manual of the medical device is insufficient, or new facts of which he/she is aware have been published in scientific magazines, describing factors that might lead to the death or serious health disorder of a patient, operator of the device or a third person.

(7) The manufacturer, the authorised representative thereof and the health care provider shall reflect the detection of risk events and notification thereof in the quality management system under the Medical Device Act or the Health Care Services Organisation Act.

The Health Board shall register a notice of risk event and inform the party having submitted the notice of the registration within 10 working days from the submission of the notice.

Regulation No. 119 of the Ministry of Social Affairs “Procedure for communication of a risk event and forms of notification“ (RTL 2004, 149, 2271; 2009, 99, 1482) is repealed.