Combinations of Medical Devices with CE Marking

Drug Master File
November 9, 2013

According to CE Marking MDD article 9.1 and the “Essential Requirements” in annex 1 of the Directive 93/42/EEC, when a medical device is intended for use in combination with another medical device or other equipment, the combination, including the connection system, must be safe, and must not impair the specified performance of the individual devices.

To ensure safety when putting into service and during use, article 13.6.c and annex 1 of CE Marking Directive 93/42/EEC require that manufacturers indicate in the instructions for use any characteristics necessary for choosing a safe combination of equipment or apparatus.

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