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