Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?
DIRECTIVE 98/79/EC
(18 June 2009)
ANNEX I
ESSENTIAL REQUIREMENTS
B. DESIGN AND MANUFACTURING REQUIREMENTS
6. Requirements for medical devices connected to or equipped with an energy source
6.1. Devices incorporating electronic programmable systems, including software, must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use.
6.2. Devices must be designed and manufactured in such a way as to minimise the risks of creating electromagnetic perturbation which could impair the operation of other devices or equipment in the usual environment.
6.3. Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided the devices are installed and maintained correctly.