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The objective of this study is to gain a deeper insight into the impact of Single Market regulation on innovation in the medical devices industry. This study looks in particular at the influence of the European Single Market on innovation in the medical devices industry. In its analysis of the regulative framework, the study concentrates on the New Approach directives 90/385 EEC "Active implantable Devices" and 93/42 EEC "Medical Devices" (Chapters 1 and 2).

The aim of the Single Market is to create an area without internal frontiers in which, by the removal of technical barriers to trade, the free movement of goods, services, persons and capital is ensured, and to improve the EUs capacity to generate economic growth (Chapter 3). The strategies to remove technical barriers within the European Union are:

1 .The mutual recognition principle.
2. Harmonisation of national regulations and standards:
-Detailed harmonisation (old approach).
-Regulation limited to essential requirements (new approach).

The Single Market has become a reality which has a definite impact on the European economy as a whole1. Nevertheless, both the Single Market and its impact are still developing, and technical barriers to trade still exist.

Additional information

Authors: STEG H, VDI/VDE-IT GmbH (DE);WHITELEGG C, Technopolis Limited (UK)
Bibliographic Reference: EUR 19734 EN (2000). Euro: Free of charge
Availability: Available from Documentation Service JRC Ispra (IT) FAX:+39-0332-785818
Record Number: 200013302 / Last updated on: 2001-06-12
Original language: en
Available languages: en
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