1. Resource-sharing amongst Member States in the field of vigilance and market surveillance 28th Meeting of the Competent Authorities for Medical Devices Krakow, 27-28th October 2011 Manfred Kohler / Peter Bischoff-Everding/ Laurent Sellès

2. Results of the resource survey shown at CAMD Madrid (3/2010) -Wide range in terms of absolute figures: 0.1 to 129 FTE for Market Surveillance and Vigilance. -Unequal distribution even when measured against population or number of products on the market. -Questions about the adequacy of the resource equipment, with effects for all: 1 inspector for up to different 500.000 MD!?

3. Can you really claim that your Member State has the manpower to assure the safety of all the Medical Devices on its territory? If not, why not look for efficiency gains?

4. 1.Many items can be checked by one Member State for all others. 2.Not everybody is good at everything = assignment according to specific knowledge is useful. Member States could increase their overall efficiency of Market Surveillance and Vigilance by jointly assigning responsibilities:

5. What 1 MS could check for all (I): Is the device really a MD? MF / AR name and address CE marking Packaging not damaged Notified Body number Content of IFU sufficient Scope of NB certificates and DoC precise, in line and broad enough.

6. What 1 MS could check for all (II): Risks reduced as far as possible Safety principles, state of the art Claimed performance achieved Risk-benefit balance is positive Technical documentation ok Quality system ok Post market surveillance plan ok Vigilance reporting works Clinical evaluation / investigation ok

7. By a “one examines for all” strategy Member States will jointly cover more products with the same manpower.

8. Who amongst you thinks that all his / her neighbouring Member States’ authorities are good at everything? Please raise you hands!

9. Who thinks that is good at everything? E.g. wrestling… Or rugby?

10. Who thinks that his / her own authority is good at everything? Please raise your hands! Don’t be shy!

11. Who thinks that his / her neighbouring Member States authorities are good at nothing? I assume no hands will go up.

12. So why don’t you share tasks according to competencies? Of course just on a voluntary basis. Maybe within regional clusters. Maybe without the big Member States for a start.

13. And why don’t you establish a “One examines for all” system for the points listed above? Of course again on a voluntary basis.

14. Thank you for your attention! When will you start?