JSM Preliminary Online Program
This is the preliminary program for the 2006 Joint Statistical Meetings in Seattle, Washington.

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Activity Number: 44
Type: Invited
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305044
Title: Statistical Regulations in the EU: Do They Exist for Medical Devices?
Author(s): Bart Gerritse*+
Companies: Medtronic, Inc.
Address: Endepolsdomein 5, Maastricht, NL-6229GW, The Netherlands
Keywords: medical devices ; regulations ; Europe
Abstract:

There are fundamental differences between clinical trials with medical devices and trials researching pharmacological treatment. To name two examples: in device trials, adverse effects often are attributable to the therapy with greater certainty and blinding is not possible. Reflecting these differences, laws and guidelines treat devices separately. In the European Union, market approval for medical devices is governed by directives on medical devices (MDD), active implantable medical devices (AIMDD), and in vitro diagnostic medical devices (IVDMD). Member states are obliged to implement these in national laws. Additionally, ISO 14155 and MEDDEV 2.7 provide guidelines for the conduct of device trials and evaluation of clinical data. This presentation will review statistical aspects of the directives and guidelines.

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Revised April, 2006