What directive applies? Audio/Visual Medical Devices

[Bunny]

The company I work for manufactures audio/visual medical devices (monitors, cameras, etc) and we have followed the various medical device regulations and testing requirements. Recently we have begun developing various types of modems and scalers. During the design review discussions we started to question whether these new products should even be considered medical devices. I am now trying to determine the correct European regulatory pathway. I believe they may be considered IT equipment. I looked on the European commission website and downloaded the EMC directive, which I will start looking at today. Where can I go to determine exactly what types of equipment these products are and the correct EU directive?

 

[Paul Simpson]

Re: What directive applies?

Hi, Bunny. If you can provide some further information about what the equipment does that will help get you a better steer from the Cexpert Covers here. Is your equipment in contact with the patient and if so, how? Similarly does your equipment actually do anything - are there any moving parts etc.?

 

[Bunny]

Re: What directive applies?

No to both - no patient contact and no moving parts.

The Fiber Optic Modem (FOM) provides electrical to optical conversion of electronic communication and data signals for transmission using tactical fiber optic cable assemblies. The FOM simultaneously receives incoming optical signals and converts them back to the original electronic signal allowing for full duplex transmission.

A video scaler is a device for converting video signals from one size or resolution to another: usually "upscaling" or "upconverting" a video signal from a low resolution (e.g. standard definition) to one of higher resolution (e.g. high definition television).

Both devices interconnect between other devices.

 

[Angelika Hoess]

Re: What directive applies?

Hi Bunny,
according to the definition of a medical device both devices are no medical devices unless they are accessories. As they interconnect between other devices - are they part of a (medical electrical) system or procedure pack as per Article 12 93/42/EEC? Did you consider the Low Voltage, RoHS and WEEE directives?
Regards, Angelika.

 

[Bunny]

I agree, I do not believe they are medical devices. However, I need to make sure that they do not require a CE Mark for another directive. They may be considered IT equipment or need to adhere to the EMC directive. We would like to be able to determine how to legally place them on the European market and I only have familiarity with the medical device directive.