eu vigilance new manufacturer incident report form piloting arrangements
Post on 21-Dec-2015
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A NEW EU MANUFACTURER INCIDENT REPORT (MIR) FORM IS COMING!
WHY?Adverse Incident
Nomenclatures
Patient harm
UDI
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)
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
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
Challenge of the new MIR form
Unfamiliar nomenclature
Routine use of this
nomenclature
Poorly categorised worldwide
data
Piloting
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 + CHc) 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
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
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 fieldssent by mfr
+
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 31st Oct 2015 with a full tested/revised MIR form with new XML schema and PDF form with embedded XML for Vigilance MEDDEV
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.
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)
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
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
Ongoing work during pilot
Expanded Trending Task Force will meet on a monthly basis and discuss• Practical/operational issues with the form• Potential additional 1st, 2nd and 3rd level terms• agreeing and communicating new 3rd level
terms for use within the pilot• EU feedback to TC210 committee
re: TS 19218 Parts 1 and 2
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
LIKELY FINAL PLACEMENT OF NEW FIELDS IN A FULLY REVISED MIR FORMTO BE PRODUCED AND IMPLEMENTED SHORTLY AFTER THE PILOTNB: THESE HAVE NOT BEEN UPDATED IN LIGHT OF WORKSHOP AGREEMENTS
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