1. www.zlg.de Session 5 – CA work program, results and ongoing work – Report from NBOG Rainer Edelhäuser Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten 28 th Meeting of Competent Authorities for Medical Devices Qubus Hotel, Cracow, Poland 28 October 2011

2. 2 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

3. 3 NBOG activities Since 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

4. 4 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

5. 55... 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 mandatory Criteria for Notified Bodies Mandatory Peer Review for DAs and NBs Mandatory Criteria for Desig- nation Process

6. 6 … 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

7. 77 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

8. 88... 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

9. 9... NBOG activities... premises on 21 June 2011 17 participants from 12 countries NBOG Peer Review Workshop took place at...

10. 10... 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

11. 11 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

12. 12 … 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

13. 13 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)

14. 14 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)

15. 15 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

16. 16 … 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

17. 17 … 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”

18. 18 Thank you for your attention! Dr. Rainer Edelhäuser Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Sebastianstraße 189 53115 Bonn Germany Tel.:+49 228 97794 12 Fax:+49 228 97794 44 E-Mail:rainer.edelhaeuser@zlg.nrw.de www.zlg.de – www.nbog.eu