28th Meeting of the Competent Authorities Matthias Neumann Federal Ministry of Health, Germany Cracow, 27th of October 2011 Central Management Committee: State of play - update Protecting public health together

CMC Report 1.Introduction 2.Current Status –Membership 3.Made Decisions and Follow-ups 4.Outcomes of the 4 th CMC meeting 5.Future Role of the CMC

Current Status Membership 31 CMC – members + 2 observers + EU- COM No nomination until now from Greece, Romania, Liechtenstein Deputies for CMC members are in many cases not yet appointed First up-dates of nominations

Current Status External communication 1.Web minutes of CMC meetings are developed and published on the CMC website 2.CMC website available under èRules of Procedure èMembership list èBasic Principles èCMC symbols and slogan èFormats for NWIP applications èDecisions èaccepted NWI èAgendas èWeb minutes of the CMC-meetings etc.

CMC Report Statistics 4 CMC meetings 3 decisions published –follow-up activities necessary Borderline/classification decisions NBOG Best Practice Guides Decision on “address of MFR or AR” 10 NWI still running –NB-designation process –NB designation criteria –Content of certificates –Content of declaration of conformity – …….

Outcomes of the 4 th CMC-meeting New Vice Chair: Joanna Kilkowska (PL) New CMC-Board member: Stelios Christofides (CY)

Outcomes of the 4 th CMC-meeting Follow-Up on decision 3 –Need of public consultations ? –Implementation of CMC decisions? NWI “Readability of IfU” –Summary report to be published –Industry and NB should be informed about CMC discussions NWI “Future Role of the CMC” to be developed

Future Role of the CMC Impact assessment (IA) of the COM is complete The CMC option seems to be described in the IA Several statements and communications from the COM services indicate that the CMC as a Committee of MS/CA will not be part of the official proposal of the COM It must be assumed that COM prefers a solution of creating an Expert Group/Committee served by or being part of EMA or JRC assisting the COM to develop implementing legal measures Is the new COM-Group/Committee a solution of our (CA) problems?

Future Role of the CMC Currently there are already a number of experts groups, which can be and are used for the development of COM legislative measures. A new group would only make sense if the COM has the intention to take over a number of additional responsibilities from the MS. It looks like, that at least following responsibilities should be transferred. –Designation, Monitoring of NB –„Approval“ of „New Emerging or High Risks Devices“ (Scrutiny) –Approval/Assessment of multilateral clinical trials –Assessment/Coordination of critical vigilance cases Are we ready for this?

Council COM Council WP Committee for Implementing Acts (Reg. 182/2011) Scientific Committee or New MDEG (experts designated by MS, EFTA, TR) input implementing/delegated acts Medical Device Database VigilanceIVD TG B+CNBOGCIENETCOEN + Other WG/TFs NBMED Appeal Committee Joint Research Centre NB designation, monitoring Scrutiny innovative products (NB input) Evaluation safety issues(Vigilance + safeguard) State of art Product verification Health Product Regulatory Network DP Orthopedics DP Cardiovascular Other DPs Network Nat Ref Labs high risk IVDs Expert Pool(s) SCENIHR Registers

Future Role of the CMC Is this model a solution of the problems identified by the CAMD? (based on existing experience) NB-designation? (Com: In the new Approach, accreditation is the last level of governmental intervention before placing on the market) How to achieve harmonised interpretation and use of the medical devices regulation? How to establish a European marketsurveilance system?

Future Role of the CMC CAMD Ad hoc group 'Prague-Uppsala group' COM already has a number of responsibilities and experts groups, such as classification/borderline (Art. 9,13 MDD) safeguard clauses (Art.8,18 MDD) particular health monitoring measures (Art. 14b MDD) requirements on NB, DA, peer review etc. (Art. 16 MDD) requirements on transparency (Art. 20) requirements on the vigilance system (Art. 10 (4) MDD) transparency, market surveillance (e.g. Art. 14a EUDAMED) But failed due to …. How should the creation of a new COM-driven expert group and the transfer of additional responsibilities be a solution ?

Future Role of the CMC CAMD Ad hoc group 'Prague-Uppsala group' Ranking of problems: view of European Competent Authorities 1Notified Bodies 2Decision making processes and instruments 3Market surveillance 4Public perception/confidence/transparency 5IVD directive 6New and emerging technologies

Council COM Council WP Committee for Implementing Acts (Reg. 182/2011) Scientific Committee or a new MDEG input implementing/delegated acts Medical Device Database VigilanceIVD TG B+C NBOG CIENET COEN + Other WG/TFs NBMED Appeal Committee Central Management Committee (MS, EFTA, TR) Harmonisation of MS responsibilities Supported by JRC, EMA or COM Oversight/Running National R- Laboratories New Emerging Technologies Evaluation critical issues DP Orthopedics DP Cardiovascular Other DPs Network Nat Ref Labs high risk IVDs Expert Pool(s) SCENIHR Registers Harmonised Market- surveillance Designation, Monitoring of NB EP Harmonised Interpretation implementation

Council COM Council WP Committee for Implementing Acts (Reg. 182/2011) Scientific Committee or a new MDEG input implementing/delegated acts Medical Device Database VigilanceIVD TG B+C NBOG CIENET COEN + Other WG/TFs NBMED Appeal Committee Central Management Committee (MS, EFTA, TR) Harmonisation of MS responsibilities Oversight/Running National R- Laboratories New Emerging Technologies Evaluation critical issues DP Orthopedics DP Cardiovascular Other DPs Network Nat Ref Labs high risk IVDs Expert Pool(s) SCENIHR Registers Harmonised Market- surveillance Designation, Monitoring of NB EP Harmonised Interpretation implementation Health Product Regulatory Network

CMC Report Outcome second CMC meeting Discussed NWIP, but not mature enough for the CMC 1.Establish and coordinate Training & Knowledge - for new colleagues - on new developments (such as comitology procedures, etc). 2.Bench marking CA performance (reply on questionnaires, participation in WG etc.) Potential CAMD issues

28th Meeting of the Competent Authorities Matthias Neumann Federal Ministry of Health, Germany Cracow, 27th of October 2011 Central Management Committee: State of play - update