Regulatory Open Forum

What are the requirements of labelling for accessory order for class I (non sterile, non measuring, but reusable) medical devices for UK, EU, AUS, US, and NZ?

Because of defective parts or any other issues, we provide replacement, etc

And when we send separately means when distributor or end user asked, we shipped in a separate box to end user and do mention PO # only in a shipping box for track only.

We don't add SN# on it anywhere

Are we compliance with US, EU, UK, AUS regulations?

Will appreciate your expert feedback

Anon,

There are a few things stated in your post which maybe need clarification because there is a mix of terminology being used which a clear response can not be provided.  An accessory for a medical device can have its own classification, but would generally be labelled with all of the "standard" regulatory information though there is some flexibility because an accessory may have limited information.  However, an accessory can still have a shelf life date or expiration date or could still have a lot number assigned.

Then you mention a component and 'provide replacement' so if speaking about spare parts or repair parts, these have some basic labelling requirements.  There is not necessarily a specific regulation for components, spare parts, or replacement parts, so many organisations use basic GMP compliance so the part is labelled with at least a part number or identification.  Some spare parts or repair parts contain a lot number, some do not.

Lastly, the customer requirements do need to be considered regardless of the regulatory requirements.  If spare parts or repair parts are being provided to a third-party such as a service depot or a distributor, these parts need to have sufficient labelling, including any instructions for use for how the components, spare part, or replacement part should be used, including once replaced what to do with the old component.

What are the requirements of labelling for accessory order for class I (non sterile, non measuring, but reusable) medical devices for UK, EU, AUS, US, and NZ?

Because of defective parts or any other issues, we provide replacement, etc

And when we send separately means when distributor or end user asked, we shipped in a separate box to end user and do mention PO # only in a shipping box for track only.

We don't add SN# on it anywhere

Are we compliance with US, EU, UK, AUS regulations?

Will appreciate your expert feedback