Separate Classifications for Medical Device Accessories

[dionysisf]

Hello,

We are a medical device manufacturer and we are producing Class IIb devices which are CE marked. We are also producing accessories such as: remote switch, carrying bags, communication module-modem, supportive software; which are being sold along with the device as a system.

The question is that if we should perform a separate classification for the accessories (e.g. some of them are Class I)?
And if yes, how we should handle the Technical File? (until now they are part of the device technical file; should the accessories have their separate technical file?)

Thanks in advance,

 

[Ronen E]

Re: Medical Device Accessories

Hi,

As a first step, you'd want to ascertain that indeed all those "accessories" fall under the official (MDD) Accessories definition. I believe that in most common cases a carry bag, for instance, would not. Look for the definition in the MDD.

Second, under the MDD Accessories are treated as devices in their own right. That means you'd have to follow annex IV to classify each of them. And yes, they should each have their own separate technical files.

When you say that they "are being sold along with the device as a system", do you mean a System in the article 12 sense? Perhaps you're better off defining the whole package as one device - if everything is sold together anyway - with one classification and one technical file.

Cheers,
Ronen.

 

[MIREGMGR]

System vs. group-of-separate-devices/accessories-as-devices is a weakness of all medical device regulatory systems.

In my view, the proper approach is to group all of the closely related accessories (that don't meet the medical device definition by themselves) into a system that is built around the primary device.

This however requires that you are the responsible maker/marketer of the primary device and all the accessories. I've been in situations where a system encompassed more than one independent, regulatorily responsible maker. In that case, there is no way forward other than to manage some or all of the various devices/accessories separately.

This is even more of a problem with US FDA, because they expect system grouping for pre-market-notified/approved devices/systems, but provide no guidance on how to manage independent-maker situations.