1. EU Vigilance New Manufacturer Incident Report Form Piloting arrangements

2. A NEW EU MANUFACTURER INCIDENT REPORT (MIR) FORM IS COMING! WHY? Adverse Incident Nomenclatures Patient harm UDI

3. 3 MD Directives implementation.vs. societal expectations

4. Why the EU needs a new MIR form Trend data is not readily available to Competent Authorities Current MIR report form does not: –facilitate the clear identification of similar incidents –provide routine incident trend data to CAs –contain sufficient nomenclature to facilitate coordination and analysis within a future European database Current EU vigilance trend form is: –poorly understood –rarely used –can lead to double reporting (potentially inefficient)

5. Benefits of the new MIR form Common nomenclature for trending & analysis Improved transparency aligned with current and likely future EU MDR Routine data on similar incidents in final reports from manufacturers, including denominator data Improved clarity of trend reporting (no double reporting) Designed with a future EU database in mind 1st step in joining up healthcare and regulatory Post Market Surveillance

6. MIR form – additional fields Additional fields within the incident report form: UDI Device Identifier & UDI Production Identifier Event-type Level 1 & Level 2 code (ISO/TS 19218-1) Evaluation Level 1 & Level 2 codes (ISO/TS 19218-2) Optional level 3 codes for both Option for up to three terms for both Patient outcome code – 30 term short-list plus 4 additional patient outcome options for pilot  SNOMED-CT, ICD-10, MEDDRA and FDA

7. Challenge of the new MIR form Unfamiliar nomenclature Routine use of this nomenclature Poorly categorised worldwide data

8. THE PILOTING OF THE MIR FORM

9. Pilot arrangements (1) 6 months piloting prior to launch of a revised individual incident report form for events reportable to the EU Testing new nomenclatures for device, event, and patient harm Provision of regular data at the final report stage for all similar incidents that have occurred: a) in the country in which the event occurred b) EEA + candidate countries + CH c) Worldwide (pilot arrangements) a revised Trend report form to be used for adverse trends in events that are not usually reportable in pilot areas Pilot live data provision from 1 May 2015 to 30 Oct 2015

10. Pilot arrangements (2) All industry send the existing PDF MIR form and/or XML schema in current use Pilot participant areas will also provide the additional data in a new PDF containing MFR incident reference and new fields for nomenclature and similar incident data Use live data (no double handling of data) Piloting with partial product range is possible Industry gather volunteer MFRs for new arrangement NBs have also been given the option to participate

11. Pilot arrangement (3) Non pilot participants Current MIR form sent by mfr Relevant CA as per MEDDEV Relevant NB Current MIR form sent by mfr Relevant CA as per MEDDEV Relevant NB Pilot participants (from 1 May 2015) New short PDF with new fields sent by mfr +

12. Piloting finalised at Vigilance MDEG Post-workshop additional PDF and guidance on the pilot and completing the PDF is being prepared ready for the 03/2015 Vigilance MDEG and will be made available on the Commission website All CAs have agreed to accept pilot PDF and current MIR form from any participating MFR Pilot participants will be committing to the use of the new fields and nomenclatures Pilot ends in 31 st Oct 2015 with a full tested/revised MIR form with new XML schema and PDF form with embedded XML for Vigilance MEDDEV

13. Piloting finalised at Vigilance MDEG Encourage all manufacturers to participate as this will help them prepare to the launch of the full form. Potential participants to be encouraged to choose product areas of high volume if they do not wish to participate with their entire product range.

14. Piloting finalised at Vigilance MDEG In addition, CAs suggest potential focused participation, where all companies in the sector would be encouraged to participate, the proposed list was: Pacemakers and leads Infusion pumps Blood Glucose Meters Surgical staplers Vaginal tapes and meshes Lasers for eye surgery External defibrillators BGMs Another IVD (e.g. Annex II products – to be agreed by EDMA)

15. Benefits of piloting For manufacturers –experience of mapping their nomenclature systems to new ones or just using new ones –experience providing the similar incident and denominator data For CAs and JRC –experience of reviewing & analysing new MIR trend data –experience of using new nomenclatures For both and with JRC –Opportunity to influence nomenclature development and use within Europe and worldwide

16. Piloting principles CAs and industry collectively agree to raise, propose, and log agreed solutions during pilot phase via a monthly expanded trending task force teleconference PDF form bugs may be fixed during pilot phase Otherwise no changes to the fields requested will be made during the pilot phase

17. Ongoing work during pilot Expanded Trending Task Force will meet on a monthly basis and discuss Practical/operational issues with the form Potential additional 1 st, 2 nd and 3 rd level terms agreeing and communicating new 3 rd level terms for use within the pilot EU feedback to TC210 committee re: TS 19218 Parts 1 and 2

18. Further strategic work Ensure further discussion on future patient harm nomenclature for later incorporation of nomenclature of choice Explore how TS 19218 nomenclature terms can be cost effectively and dynamically managed in the future

19. LIKELY FINAL PLACEMENT OF NEW FIELDS IN A FULLY REVISED MIR FORM TO BE PRODUCED AND IMPLEMENTED SHORTLY AFTER THE PILOT NB: THESE HAVE NOT BEEN UPDATED IN LIGHT OF WORKSHOP AGREEMENTS

20. Potential location of the New fields (1)

21. Potential location of the New fields (2)

22. Potential location of the New fields (3)

23. Potential location of the New fields (4)

24. Potential location of the New fields (5)

25. Guidance on completion of new form in Revised MEDDEV