35th COMPETENT AUTHORITY MEDICAL DEVICE MEETING

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1 35th COMPETENT AUTHORITY MEDICAL DEVICE MEETING The Medical Device Vigilance System in Italy Rosaria Boldrini Head of Unit V General Directorate of medical devices and pharmaceutical service Ministry of Health Rome, 16th October 2014

Head of Unit V General Directorate of medical devices and

2 Medical Devices integrated sector Medical devices sector is extremely complex. It is characterized by an high level of dynamism, heterogeneity of products, high number of actors and organic legislation Manufacturers Vigilance System Clinical Investigations Medical Device Market Surveillance NHS Expenditure on MD Pre-market EC Certificates 2 Post-market

of actors and organic legislation Manufacturers Vigilance System Clinical Investigations

3 The focus of this section In this section we will focus on the Medical Device Vigilance System in Italy 3

4 Principal purpose The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, users and others by means of: The rapid identification of each new problem in order to identify corrective actions The sharing of information between Competent Authorities and manufacturers to obtain a timely application of corrective actions The monitoring of an effective and correct implementation of corrective actions The prevention of the reiteration of similar incidents thanks to the implementation of appropriate corrective measures and the publication of warnings 4

Authorities and manufacturers to obtain a timely application of corrective actions The monitoring of an effective and correct implementation of corrective

5 The actors involved There are several actors from different institutional levels involved in the Medical Device Vigilance System National Competent Authoritiesin UE Member States Italian Ministry of Health Healthcare professionals Regions Healthcare Local Authority Italianand foreign manufacturers MEDICAL DEVICE VIGILANCE SYSTEM 5

UE Member States Italian Ministry of Health Healthcare professionals Regions

6 Dispovigilance - Main features Dispovigilance is the IT System to support the Medical Device Vigilance System. It is designed to manage data on incidents related to medical devices, FSCA (Field Safety Corrective Actions), NCAR (National Competent Authority Reports) and the transmission of data to the European database Eudamed. The system also allows the management of FSNs (Field Safety Notice) and gives the possibility to publish them on the Italian Ministry of Health website, for online consultation by the operators and citizens. Incident Management Alert Management Corrective actions Medical Device VigilanceSystem Data transmission to EudamedDB NCAR 6

transmission of data to the European database Eudamed.

7 Recent update of the Medical Device Vigilance System During 2014, we have implemented additional features in Dispovigilance in order to meet the requests of the Italian Regions for a centralized system able to improve the information s circulation. This is the first step to create a national network. The main updates are: Online Incident Report forms for healthcare professionals and Manufacturers NCAR uploads New access credentials for Italian Regions and Local Health Authorities XML file and a csv file generation for data acquisition for different regional DB Reports for data consultation 7

This is the first step to create a national network.

8 New online incident report form Healthcare professional a) Assisted search of healthcare facilities and medical devices in national databases. Pre-filled sections of the form b) Mandatoryfieldsand data consistencyvalidationto ensurethe qualityand the integrity of data entries The new online report allows the user to send event highlights to the Ministry of Health. The process is divided into 4 steps: Data entry of the information regarding the place of the event Data entry of the information regarding the medical device Data entry of the information regarding the event Data entry of the information regarding the compiler 8

allows the user to send event highlights to the Ministry of Health.

9 New online incident report form Healthcare professional (1/4) The online reports are sent by each health facility: -Hospitals -Community care facilities -Pharmacies, GP, Clinics (LHA) 9

10 New online incident report form Healthcare professional (2/4) The identification of medical device is guaranteed by the "Identifying registration number" used in the Italian Databank of Medical Device 10

11 New online incident report form Healthcare professional (3/4) The main information about the event are requested 11

12 New online incident report form Healthcare professional (4/4) The main information about the compiler are requested 12

13 How to send the report Ministry of Health webpage Compilation of online report Creation of the report in.pdf clicking the "Invia Rapporto" button Sending the report Information at: 13

pdf clicking the "Invia Rapporto" button Sending the report Information

14 Online Incident Report form for Manufacturers 14

15 EUDAMED NCAR upload It s now possible to upload NCAR reports downloaded from Eudamed 15

16 Functionality of consultation data The new profiles can browse the incident related data. In addition, it will be possible to consult the outcome of the investigation once the report has been completed by the Ministry of Health. Research on the reports Outcome of the report Results 16

In addition, it will be possible to consult the outcome of the

17 Italian Regions data download The Italian Regions can download data on their incidents in.xml or.csv files Monitoringfunctionofthe researches 17

18 The expected benefits Optimizationofthe investments Information sharing Italian Ministry of Health Integration with the Medical Devices Consumption National DB Centralized National MD Vigilance System EuropeanMD Vigilance System Operatore The centralized system allows the optimization of investments since any adjustments for compliance with the European system would be provided by the Central Administration. Healthcare professionals Segnalazione Centralized National MD Vigilance System Local Health Authoritiy The new profiles Regions and Local Health Authorities allow better sharing of information 18 Regions Centralized National MD Vigilance Medical Devices Consumption National BD Operatore System The Medical Device Vigilance System is linked with both the National Repertory of Medical Devices and the Medical Devices Consumption National DB. These links allow to analyze the risks of medical devices taking into account the frequency of use and the potential users involved.

19 Italian data on Vigilance System Incident's Manufacturer Healtcare Manufacturer & Healthcare All Incident Year Report professional Report professional Report Reports ND Total

Report professional Report Reports 2012 920 828 249 1997 2013 1339

20 Italian data on Vigilance System Incident Reports by first level of CND (National Classification of Medical Devices) Multi-level hierarchical classification 20

21 Thank you for your attention! Rosaria Boldrini Head ofunitv General Directorate of medical devices and pharmaceutical service Ministry of Health 21

Bilgehan Karadayı Turkish MoH

Bilgehan Karadayı Turkish MoH Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy Social Security Agency Turkish Practice on Medical Device UDI Bilgehan Karadayı, MD Head of