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28th Meeting of the Competent Authorities
Matthias NeumannFederal Ministry of Health, GermanyCracow, 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 4th 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 communication1. Web minutes of CMC meetings are developed and published on the
CMC website
2. CMC website available under www.cmc-md.eu Rules of Procedure Membership list Basic Principles CMC symbols and slogan Formats for NWIP applications Decisions accepted NWI Agendas
Web 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 4th CMC-meeting
New Vice Chair:
• Joanna Kilkowska (PL)
New CMC-Board member:
• Stelios Christofides (CY)
Outcomes of the 4th 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
Vigilance IVD TGB+CNBOG CIE NETCOEN +Other WG/TFs NBMED
Appeal Committee
Joint Research Centre
NB designation, monitoring
Scrutiny innovative products (NB input)
Evaluation safety issues(Vigilance + safeguard)
State of artProduct verification
Health Product Regulatory Network
DP Orthopedics DP CardiovascularOther DPs
Network Nat Ref Labs high risk IVDs
Expert Pool(s)
SCENIHRRegisters
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 Authorities1 Notified Bodies2 Decision making processes and instruments3 Market surveillance4 Public perception/confidence/transparency5 IVD directive6 New and emerging technologies
Council
COM
Council WP
Committee for Implementing Acts (Reg. 182/2011)
Scientific Committeeor a new MDEGinput implementing/delegated acts
Medical Device Database
VigilanceIVD TGB+C
NBOG
CIENET
COEN
+Other WG/TFsNBMED
Appeal Committee
Central Management Committee(MS, EFTA, TR)Harmonisation of MS responsibilities
Supported by JRC, EMA or COM
Oversight/Running NationalR- Laboratories
New Emerging Technologies
Evaluation critical issues
DP Orthopedics DP Cardiovascular Other DPs
Network Nat Ref Labs high risk IVDs
Expert Pool(s) SCENIHRRegisters
Harmonised Market-surveillance
Designation, Monitoring of NB
EP
Harmonised Interpretation implementation
Council
COM
Council WP
Committee for Implementing Acts (Reg. 182/2011)
Scientific Committeeor a new MDEGinput implementing/delegated acts
Medical Device Database
VigilanceIVD TGB+C
NBOG
CIENET
COEN
+Other WG/TFsNBMED
Appeal Committee
Central Management Committee(MS, EFTA, TR)Harmonisation of MS responsibilities
Oversight/Running NationalR- Laboratories
New Emerging Technologies
Evaluation critical issues
DP Orthopedics DP Cardiovascular Other DPs
Network Nat Ref Labs high risk IVDs
Expert Pool(s) SCENIHRRegisters
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 NeumannFederal Ministry of Health, GermanyCracow, 27th of October 2011
Central Management Committee: State of play - update