www.zlg.de session 5 – ca work program, results and ongoing work – report from nbog rainer...
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www.zlg.de
Session 5 – CA work program, results and ongoing work – Report from NBOG
Rainer Edelhäuser
Zentralstelle der Länder für Gesundheitsschutzbei Arzneimitteln und Medizinprodukten
28th Meeting of Competent Authorities for Medical Devices
Qubus Hotel, Cracow, Poland
28 October 2011
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Contents
NBOG activities since the last CA Meeting in Budapest
Work Program 2011 – ongoing projects
Action required Aiming on a real peer review system
as part of the regulatory system
Introduction of a NBOG mechanism for solving of differing opinions
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NBOG activitiesSince the last CA Meeting in Budapest
Participation in High-Level Conference on MD 15 March 2011 Participation in MDEG “Special Recast” 31 March / 1 April 2011 Participation in NB-MED Meeting 5 April 2011 Meeting with J. van Lochem, NB “Chair of Big 5”, 8 April 2011 Pre-Meeting (EU) for ISO/TC 210/WG 1/PMS – Revision ISO 13485 –
10 April 2011 and Participation in ISO/TC 210/WG 1 Joint Meeting 11-12 April 2011
NBOG Workshop on Peer Review 21 June 2011 NBOG meeting 22 June 2011 Participation in CEN Special TF ISO 14971 + ISO 13485 25 Aug 2011 Participation in NB-MED Meeting, 5 October 2011
And written reports / feedback to
CEN TC3, COM, EA (via nat. AB), GHTF SG 1 and 3, IAF (MDCAS), ISO TC 210, NB-MED/NBRG, Recast Mirror Group, TSE/BSE WG, and various MS
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NBOG Work Program – Projects 2011
Current work items
Revision of NBOG BPG 2010-3(Certificates) agreed in Madrid
also covered by a work item agreed by CMC
Relation to EUDAMED
Next step -> Questionnaire to be circulated
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... Work Program Result of Working Group discussions
For the Designation and Monitoring of Notified Bodies, three areas needing update or to be introduced have been identified
More specific
mandatoryCriteria
forNotifiedBodies
MandatoryPeer
Reviewfor
DAs andNBs
MandatoryCriteria
forDesig-nation
Process
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… Work Program – Projects 2011
Follow-up of projects (NWI) on designation criteria and designation process as agreed by the CMC
Follow-up of the Peer Review program, discussion and revison of checklist/report form used as pilot; aim is to develop a criteria set for peer review
-> Separate workshop
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NBOG activities
with respect to the Designation Process
Discussion on special items in the last meeting
Small group developed a description of the process including details (e.g. roles and responsibilities of DA and assigned European assessors, reporting)
Discussion at CMC Meeting this week
Follow-up of the discussion at next the NBOG meeting / workshop on 8 November 2011
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... NBOG activities
with respect to the Designation Criteria
Discussion on special items (independence, subcontracting) in the last meeting
Small group is drafting a proposal based on existing sources (Annex XI, 768/2008/EC, GHTF SG 4 documents, KAN reports, MEDDEV 2.10/2, NBOG DA Handbook, Code of Conduct, ...)
Discussion at CMC Meeting this week
Follow-up of the discussion at next NBOG meeting / workshop on 8 November 2011
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... NBOG activities
... premises on 21 June 2011
17 participants from 12 countries
NBOG Peer Review Workshop took place at...
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... NBOG activities
Role of “observers” and “European assessors” Language Reporting requirements, output Resources, costs Procedural aspects Solving of differing opinions
with respect to the Peer Review Process
Items discussed = Input also for the discussion on the designation process
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Proposal for CAMD
Peer review is an essential part of the system Current program focus more on exchange of
experience and sharing of best practice but future system should aim for real peer review
and should be part of regulatory system Peer review does not replace designation
process
Important difference: Peer review must focus on the DA’s performance, not on the NB’s performance
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… Proposal for CAMD
Issue “Solving of differing opinions”
How to proceed when different interpretations of requirements or situations (e.g. on legal subjects) were identified?
-> Mechanism for identification and clarification in NBOG would / could be a solution
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Guidance on Changes of the approved design
Guidance for Renewal of Certificates(see NBOG BPG 2009-1)
… other projects 2011
Deeper discussion on first item in the last meeting
Follow-up planned for next meeting(s)
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Agreement on 6 „Questions and Answers“ from COEN related to certificates
Revision of checklists and forms within the DA Handbook to align them with the requirements of directive 2007/47/EC
… other projects 2011
Postponed to next meeting(s)
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Action required
Discussion about NBOG proposal(s)
1. That a real Peer Review of Designating Authorities should be part of the regulatory system
Peer review can not and does not not replace the designation process
Important difference: Peer review must focus on the DA’s performance, not on the NB’s performance
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… Action required
2. Issue “Solving of differing opinions”
Do you agree that NBOG should establish a mechanism for identification and clarification of identified (different) interpretations of requirements or situations (e.g. on legal subjects)?
-> if yes = new (permanent) work item
-> depending if consensus can be reached issues need to / will be forwarded to CMC
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… Action required
Please discuss / decide
1. That a real Peer Review of Designating Authorities should be part of the regulatory system
2. Work item “Solving of differing opinions”
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Thank you for your attention!
Dr. Rainer EdelhäuserZentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und MedizinproduktenSebastianstraße 18953115 BonnGermanyTel.: +49 228 97794 12Fax: +49 228 97794 44E-Mail: [email protected]
www.zlg.de – www.nbog.eu