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Guideline on medical Devices MEDDEV 2.1/3 rev. 3 (July 2009) INTRODUCTION The demarcation between the Medical Devices Directive 93/42/EEC (MDD)3 and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD)4 on the one hand and the Medicinal Products Directive 2001/83/EC5 (MPD) on the other hand is crucial for the proper implementation of these Directives and the correct interpretation and
enforcement of national laws. Therefore, several provisions to establish the demarcation between both legal regimes have been laid down in the MDD, AIMDD and MPD. However, it was recognised that the subject needs to be further explained and illustrated by practical guidance. The MEDDEV is available in our library. Or may be downloaded directly here: MEDDEV 2.1/3 rev. 3 |
