Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,
We are developing a motorized Storage Rack that is used only to store a module (one detachable component) of the approved medical device when that component is not in use. This Storage Rack serves no medical utility and is also not considered an accessory to a medical device. Often it's more comfortable to include such an item as part 'of the system' but we were told definitively not to by our Standards testing house, that 60601-1 is not applicable, and we are testing per the harmonized standard for equipment lifting, 1570-1. Also, we completed technical documentation including risk analysis, specs, v&v, and a user manual, but do not have Essential Requirements and no conventional tech file. 
We thought to 'place it on the market' in the EU per the Machinery Directive.
So a few questions:

• I assume to be sold in EU, it needs a CE mark on the label, right?
• And because it's not under the authority of our notified body, the label would not have their number, right?
• Who is the authority for regulating this Rack? As it's not a medical device, and not in their tech file, our notified body would likely never see the technical documentation. Is this a question to ask the notified body if they also cover machinery directive for this item? 
• Is the requirement on me as the manufacturer to proactively locate such a regulatory authority or is it sufficient that I self-declare for this item on the strength of the technical documentation?

Thanks very much for any advice!

Some of the directives include a requirement for CE marking and/or notified body involvement and others do not.

See the Blue Guide for some explanation of when a CE mark must be applied and when it must not be applied.
If your rack is motorized it may also fall under the Low Voltage Directive. ​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 02-Feb-2021 02:37
From: Anonymous Member
Subject: EU Regulatory Requirements for non-Medical Device

This message was posted by a user wishing to remain anonymous

Hello everyone,
We are developing a motorized Storage Rack that is used only to store a module (one detachable component) of the approved medical device when that component is not in use. This Storage Rack serves no medical utility and is also not considered an accessory to a medical device. Often it's more comfortable to include such an item as part 'of the system' but we were told definitively not to by our Standards testing house, that 60601-1 is not applicable, and we are testing per the harmonized standard for equipment lifting, 1570-1. Also, we completed technical documentation including risk analysis, specs, v&v, and a user manual, but do not have Essential Requirements and no conventional tech file.
We thought to 'place it on the market' in the EU per the Machinery Directive.
So a few questions:

• I assume to be sold in EU, it needs a CE mark on the label, right?
• And because it's not under the authority of our notified body, the label would not have their number, right?
• Who is the authority for regulating this Rack? As it's not a medical device, and not in their tech file, our notified body would likely never see the technical documentation. Is this a question to ask the notified body if they also cover machinery directive for this item? 
• Is the requirement on me as the manufacturer to proactively locate such a regulatory authority or is it sufficient that I self-declare for this item on the strength of the technical documentation?

Thanks very much for any advice!