1. New Rules for Clinical Investigations in Germany
Dr. Matthias Neumann
Federal Ministry of Health
Berlin
III National Conference on MD - Rome, April 2010

2. Clinical Investigations in Germany before 21st March 2010
Manufactures/sponsors had to notify the regional CA. In case of an positive opinion of an Ethic committee they could start immediately otherwise they had to wait 60 days
The responsibility on clinical investigations was split on more than 70 competent authorities
These authorities had serious problems to keep the necessary expertise and manpower to fulfil their obligations (check of notifications, assessment of serious adverse incidents during clinical investigations)

3. Clinical Investigations in Germany before 21st March 2010
Ethics committees (EC) have been overloaded with tasks (e.g. assessment of the technical safety of the investigational devices)
“negative” competition between EC occurred (faster, cheaper,….)
In UK, FR, Switzerland annually around 20 % of applications on clinical investigations have not been approved. In Germany no data on rejections or non-approvals available, despite around 50% of all European clinical investigations are performed in Germany.
No or very limited data on incidents during clinical investigations were available

4. Clinical Investigations in Germany before 21st March 2010EC EC
Notification
on regional CA
Pos. EC-Opinion
Mfr/
Sponsor EC
Start EC
Wait for 60 days

5. Competent Authorities for Medical Devices in Germany
ZLG
Central Authority of the Laender
for Health Protection Regarding Medicinal products and medical devices
Bonn
BMG
Federal Ministry for Health
Berlin and Bonn
BfArM
Federal Institute for Drugs and Medical Devices
Bonn
PEI
Paul-Ehrlich-Institute
Langen
DIMDI
German Institute of Medical Documentation and Information
Bonn
Highest Laender Authorities

6. Clinical Investigations in Germany after 21st March 2010
Centralisation of responsibilities
Mfr/Sponsor of a clinical investigation need an approval of Federal Competent Authority (BfArM or PEI) and a positive opinion on the clinical investigational plan by an Ethics committee (EC)
The approval by the authority will be issued within 30 days (otherwise fictional approval)
The EC has to decided within 60 days
Tasks of CA and EC are clearly separated
CA - scientific and technical analysis of the device safety and of the investigational plan
EC - legal, ethical medical assessment of the investigational plan with regard to the existing rules on clinical investigations

7. Clinical Investigations in Germany before 21st March 2010
Approval or silence
30 days*
Mfr/
Sponsor
Start
Electronic
Application EC
60 days
positive opinion
EUDAMED
* For some low risk devices there will be an easier
and cheaper CA approval procedure

8. Clinical Investigations in Germany after 21st March 2010
Serious adverse events during clinical investigations have to be reported by the Sponsor and by the clinical investigator to BfArM
This is also applicable for clinical investigations started before March 21st 2010
BfArM will assess reports, conclusions and, actions taken by the Sponsor
If necessary BfArM has to order a stop of a clinical investigation or has to withdrawal the approval
BfArM/PEI will communicate with the European partners

9. Ordinances in preparation
Federal Ministry of Health wanted to establish two additional ordinances until
Ordinance on clinical investigations
describing the approval procedures for clinical investigations (CI)
Which information have to be provided to the EC and CA
What are the procedures and tasks at the CA and EC
Amendments of Cl
Surveillance of CI by the local CA etc.
Amendment of the DIMDI-Ordinance
Establishing an electronic application format for CI which will be used by the CAs and by the ECs
New date: 7th of May 2010

10. New Rules for clinical investigations in Germany
Thanks for your attention !!
Dr. Matthias Neumann
Federal Ministry of Health, Berlin
III National Conference on MD - Rome, April 2010