Pursuant to Article 56 of the Medical Devices Act (Uradni list RS, No. 98/09), the Minister of Health hereby issues

RULES ON VIGILANCE OF MEDICAL DEVICES

I. GENERAL PROVISIONS

1. Article 1

(Scope of application and terms of reference)

(1) These Rules lay down more detailed rules regarding the system of detection, collection,

evaluation and reporting on any medical device-related complications, the system of reporting and implementation of corrective measures and other obligations of participants in the vigilance of medical devices.

(2) The participants in the vigilance of medical devices shall be:

medical device manufacturer,

authorised representative of medical device manufacturer (thereinafter: (manufacturer’s representative),

business entities established in the Republic of Slovenia, carrying out wholesale or retail trade in medical devices,

medical device importer established in the Republic of Slovenia,

Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: Agency),

notified body,

providers of healthcare, pharmacist and other services using medical devices in performing their activities, and

Users. (3) The body responsible for the area of vigilance of medical devices is the Agency.

2. Article 2

(Definitions and terms)

Besides the terms and definitions as defined in Articles 3 to 9 of the Medical Devices Act (Uradni list RS, No. 98/09) the following terms shall also be applied in these Rules:

1. Corrective measure is a measure used for eliminating the cause of non-compliance or any other adverse event related to medical device. A corrective measure shall be implemented to prevent the recurrence of non-compliance or adverse event.

2. Preventive corrective measure is a measure implemented by the medical device manufacturer or his representative to reduce the risk of death or severe deterioration of health condition associated with the use of medical device already available on the market.

3. Security notice is written information on a preventive corrective measure sent to the users by the medical device manufacturer or his representative.

4. Severe threat to public health is any event that causes death, severe deterioration of health condition or serious illness which requires an immediate medical intervention.

5. Periodic reporting with summaries is a way of reporting agreed upon by a medical device manufacturer or his representative and the Agency regarding similar adverse events with the same medical device or type of medical devices, where the cause of origin is unknown or a preventive corrective measure has been introduced.

6. Reporting with trends is a reporting used by the medical device manufacturer or his representative when there is a significant increase in the number of adverse events associated with medical devices.

7. Event is every malfunction or deterioration of the properties or capacity of a medical device from medical or technical point of view, as well as all inconsistencies in labelling or instructions for use.

3. Article 3

(Criteria for determining an adverse event associated with medical device)

(1) The criteria for determining an adverse event associated with medical device are as follows:

the adverse event has actually occurred,

It is suspected that a medical device-related complication is associated with the event, and

The event has caused or might cause death of a patient, user or other person, or severely deteriorate a patient's, user's or other person's health condition.

(2) The participants in the system of vigilance of medical devices shall report any medical

device-related adverse event occurring in the territory of the Republic of Slovenia to the Agency when all the criteria referred to in the preceding paragraph are met.

4. Article 4

(Preventive corrective measures)

(1) A preventive corrective measure shall be introduced on the basis of a medical device related complication, provided that the criteria referred to in the preceding Article have been met.

(2) A preventive corrective measures may include:

revocation or withdrawal of medical device;

change of medical device;

replacement of medical device;

Destruction of medical device;

adjustment or remodelling of a medical device for the user, which shall be performed by medical device manufacturer or his representative;

advice by medical device manufacturer or his representative regarding the use of medical device.

(3) Change of medical device may include:

permanent or temporary change of labelling or instructions for use;

software update, including remote access update;

change of patients’ clinical treatment where the risk of death or severe deterioration of health condition is associated particularly with medical device properties.

(4) A preventive corrective measure shall be submitted to the users in the form of a security notification.

5. Article 5

(Security notification)

(1) A security notification shall include the following:

title “Urgent security notification” followed by trade name of the medical device and the type of preventive corrective measure,

information identifying the concerned medical device, Statement on the facts explaining the reasons for the preventive corrective measure,

including the specification of deficiencies or malfunctioning of the medical device, the explanation of possible hazards associated with further use of the medical device, the associated risks for patients and users as well as possible risks for patients due to any previous use of the concerned medical devices,

advice regarding the measure to be implemented by the user,

a request that the security notification be forwarded to all whom it may concern,

name of contact person.

(2) The application form for security notification MedPri-VIG-obr04 is available on the JAZMP website at www.jazmp.si.

(3) A security notification for the territory of the Republic of Slovenia shall be in the Slovene language.

(4) Evidence that the security notification has been forwarded to the user shall be submitted to the Agency by the medical device manufacturer or his representative or by a business entity carrying out wholesale trade in medical devices on request.

II. THE ROLE OF THE PARTICIPANTS IN THE SYSTEM OF VIGILANCE OF MEDICAL DEVICES

6. Article 6

(The role of manufacturers)

(1) Medical device manufacturer or his representative shall notify the Agency within 24 hours of any medical device related complication. The notification shall be submitted to the Agency in paper or electronic form using the MedPri-VIG-obr02 form Medical device manufacturer’s report of medical device-related adverse event (hereinafter: MedPri-VIG-obr02), which is available on the www.jazmp.si website.

(2) (2) The notification referred to in the preceding paragraph shall include the following:

Administrative data specifying the type of report(preliminary, additional, final report),

data on medical device manufacturer or his representative,

data on the medical device that is subject to the reported adverse event,

Data on adverse event,

general data on the patient involved in the adverse event

data on the healthcare institution where the adverse event occurred,

data on the outcome of the final investigation of the adverse event, data on medical device manufacturer’s preliminary analysis,

data on initial corrective measures,

Information on the countries where the concerned medical device is marketed.

(3) In the case there is a doubt regarding compliance with the criteria referred to in Article 3 of

these Rules on the notification of adverse events, medical device manufacturer or his representative shall notify the Agency if there is a severe threat to public health within two days, in the case of death or unexpected severe deterioration of health condition within ten days, or in other cases within 30 days after being informed of the event, using the MedPri-VIG-02 form.

(4) Medical device manufacturer or his representative shall be responsible for the investigation

of adverse events and the implementation of corrective measures. (5) Medical device manufacturer or his representative shall notify the Agency in writing of the

implementation of preventive corrective measures. (6) When the adverse event occurs as a result of the use of two or more separate medical

events of different medical device manufacturers or their representatives, each medical device manufacturer or his representative shall notify the Agency in paper or electronic form of the adverse event by submitting a report on MedPri-VIG-obr02 form.

(7) Medical device manufacturer or his representative shall also submit the report on an

adverse event that has occurred in other EU Member States to the competent authority of the EU Member State where the event occurred, using MedPri-VIG-obr02 form.

(8) In the case that marketing of the medical device has been terminated, the medical device manufacturer or his representative shall, pursuant to these Rules, report on any adverse events associated with the concerned medical device as long as the latter is available on the market.

(9) In the case when the obligations under the system of vigilance of medical devices are

transferred to another business entity after medical device’s placement on the market, the Agency shall be notified in writing of the change within ten days after the implementation of the change.

(10) Medical device manufacturer or his representative shall introduce and currently update

the system of vigilance of medical devices after their placement on the market as well as after the end of manufacture of medical devices.

(11) When a medical device manufacturer or his representative finds out that he is incapable

of further investigating the adverse event, he shall notify the Agency of that in writing within three working days. The Agency may require the submission of the previously compiled documentation and shall - after having consulted the medical device manufacturer or his representative – continue the investigation commenced by the medical device manufacturer or his representative, or start an independent investigation.

(12) Medical device manufacturer or his representative shall inform the notified body in writing

of the matters occurring after the completed manufacture and influencing the acquisition of EC certificates.

(13) Medical device manufacturer or his representative shall also submit a copy of security

notification to the notified body that has carried out the conformity assessment procedure for the concerned medical device.

7. Article 7

(The role of the notified body)

The notified body shall participate in the system of vigilance of medical devices in:

the assessment of vigilance procedures for medical devices;

the assessment of the influence of vigilance cases on the issued EC certificates;

cooperation with the Agency at their request.

8. Article 8

(The role of the Agency)

For the purpose of establishing and managing the system of vigilance of medical devices, the Agency shall execute the following tasks:

collects and evaluates reports on medical device-related adverse events in cooperation with medical device manufacturer or his representative;

follows up the medical device manufacturer’s or his representative’s investigation of a medical device-related adverse event;

Introduces any further measure needed for updating the measures implemented by medical device manufacturer or his representative;

upon the receipt of a notification of medical device-related adverse event, sends a copy of the notification to the medical device manufacturer or his representative, if the latter have not been informed about that.

Cooperates with the authorities responsible for medical devices in other EU Member States in the system of international information exchange on adverse events and corrective measures.

9. Article 9

(The role of other participants)

(1) Healthcare, pharmacist and other service providers shall notify the Agency in paper or electronic form not later than within 24 hours from a medical device-related adverse event or from their being informed about it, of the event, using MedPri-VIG-obr01 form – Report of a medical device-related adverse event, which is available on the www.jazmp.si website. They may also notify

the manufacturer of medical devices or the manufacturer’s representative about the complication. (2) (2) The notification referred to in the preceding paragraph shall include the following:

information about the rapporteur,

data on the medical device involved in the adverse event,

data on the adverse event.

(3) (1) Business entities carrying out wholesale or retail trade in medical devices and importers of medical devices shall notify the Agency in paper or electronic form about the event not later than within 24 hours of their being informed about the event, using MedPri-VIG-obr02 form.

(4) Business entities carrying out wholesale or retail trade in medical devices shall be

responsible for the implementation of a preventive corrective measure following the instructions of the medical device manufacturer or his representative.

(5) Business entities carrying out wholesale trade in medical devices shall provide the Agency,

at its request, with the list of users and other business entities in the Republic of Slovenia that are included in the preventive corrective measure.

III. (REPORTING SYSTEM)

10. Article 10

(Reporting on medical device related complications)

(1) Each preliminary report by medical device manufacturer or his representative regarding

medical device-related adverse event shall be followed by a final report unless the preliminary and the final report are merged into a single report. The type of report shall be specified by the medical device manufacturer or his representative on MedPri-VIG-obr02 form.

(2) Manufacturers of medical devices or their representative shall investigate each case of

medical device-related adverse event of which they have been notified, and report their findings to the Agency, using MedPri-VIG-obr02 form.

(3) Manufacturer of medical devices or his representative shall investigate each case of

medical device-related adverse event that has occurred in a third country and resulted in a preventive corrective measure in the EU Member States, and report about the event to the Agency.

(4) In the case of lacking information on medical device-related adverse event, medical device

manufacturer or his representative shall not delay their report to the Agency. (5) Medical device manufacturer or his representative shall prepare an additional report for the

Agency, if the duration of medical device-related adverse event investigation exceeds the deadline laid down in the preliminary report on the event.

11. Article 11

(Periodic reports with summaries or trends)

(1) Provided that the Agency has been previously provided with at least one report on medical device-related adverse event, the medical device manufacturer or his representative may submit their periodic reports in the form of summaries or trends.

(2) Medical device manufacturer or his representative shall agree with the Agency on the form

of periodic reports with summaries or trends.

12. Article 12

(Consideration of reports on adverse events submitted to the manufacturer by the Agency)

(1) If receiving a report from the Agency regarding medical device-related adverse event, the medical device manufacturer or his representative shall submit to the Agency a preliminary report in accordance with the criteria referred to in Article 3 of these Rules.

(2) If the medical device manufacturer or his representative believes that medical device-

related adverse event does not meet the criteria referred to in Article 3 of these Rules, he shall provide the Agency with a relevant substantiation.

13. Article 13

(Investigation of an adverse event)

(1) Medical device manufacturer or his representative may discuss with the user the occurrence of the event prior to reporting about it to the Agency.

(2) The healthcare, pharmacist or other service provider shall allow the medical device

manufacturer or his representative access to the medical device that has caused the adverse event.

(3) Based on medical device examination and provided that the criteria referred to in Article 3

of these Rules are met, the medical device manufacturer or his representative shall decide whether he shall report the medical device-related adverse event to the Agency.

(4) If the medical device manufacturer or his representative is allowed access to the medical device and his first examination would include a change to medical device in the way that may influence further investigation of the adverse event, the medical device manufacturer or his representative shall notify the Agency thereof beforehand in writing. Based on the notification received, the Agency may decide on further measures.

14. Article 14

(Adverse event investigation outcome)

(1) Prior to the implementation of a preventive corrective measure, medical device manufacturer or his representative may consult the Agency, which may introduce an additional measure.

(2) Medical device manufacturer or his representative shall notify the Agency of the course of investigation within the time limits set in the preliminary report.

(3) The outcome of the investigation of a medical device-related adverse event and the

measures regarding that shall be submitted to the Agency in the final report by medical device manufacturer or his representative.

(4) If the investigation is carried out by the Agency, the latter shall notify medical device

manufacturer or his representative of the outcome of investigation.

15. Article 15

(Notification of the Agency)

(1) Medical device manufacturer or his representative shall notify in paper or electronic form the Agency and the authorities responsible for medical devices in the EU Member States, where the concerned medical devices are marketed, of the preventive corrective measure by the Report on preventive corrective measure, using MedPri-VIG-obr03 form, which is available on www.jazmp.si website.

(2) The report referred to in the preceding paragraph shall include the following:

description and substantiation of the corrective measure,

advice regarding the measures to be implemented by the user and the business entity,

detailed data on the medical device that is subject to the adverse event, data on medical device manufacturer or his representative,

information on the countries implementing the preventive corrective measure.

(3) Business entities performing wholesale trade in medical devices and importers of medical devices established in the Republic of Slovenia shall notify the Agency of the receipt of notification referred to in the preceding paragraph and of the preventive corrective measure implementation.

(4) Prior to or concurrently with the implementation of a preventive corrective measure, the medical device manufacturer or his representative shall submit to the Agency a copy of the security notification together with the form referred to in the first paragraph of this Article. A security notification with the same content shall be also sent by the medical device manufacturer or his representative to the business entities performing trade in the concerned medical device. Medical device manufacturer or his representative shall notify the Agency of the completion of preventive corrective measure.

IV. TRANSITIONAL AND FINAL PROVISIONS

16. Article 16

(Repeal)

(1) As of the date of entry into force of these Rules, the provisions of Article 10 of the Rules on Medical Devices (Uradni list RS, No 71/03, 51/04 and 98/06) and of Article 11 of the Rules on In Vitro Diagnostic Medical Devices (Uradni list RS, No 47/02, 75/03 and 51/04), shall cease to apply.

(2) As of the day of the entry into force of these Rules, the Order on the appointment of legal

entity for monitoring the adverse effects of medications and adverse effects of medical devices (Uradni list RS, No. 100/00) in the part relating to medical devices shall cease to apply.

17. Article 17

(Entry into force) These Rules shall enter into force on the day following their publication in Uradni list RS.

No. 715-0012/2010 Ljubljana, 18 May 2010 EVA 2009-2711-0070

Dorjan Marušič MINISTER