Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

We are planning to treat our Class I-self certified product (made of textile) with an active substance (PT-9) to protect the product from odor and to make odor control claim. Since this treatment doesn't have any impact on the human but gives a secondary biocidal benefit to the product, I have two questions in mind:
- Does this treatment change my MD product classification? 
- Do we need to follow EU BPR labelling requirements for treated articles (label the product with the name of active substances)?

Thanks,

This message was posted by a user wishing to remain anonymous

Hi

1. To determine your device's EU classification, follow the rules in MDR Annex VIII. (It doesn't say much about the materials used.)
2. I don't know of any exceptions to the BPR labelling rule.
Original Message:
Sent: 28-Sep-2022 05:15
From: Anonymous Member
Subject: medical device treated with an active substance

This message was posted by a user wishing to remain anonymous

Hi All,

We are planning to treat our Class I-self certified product (made of textile) with an active substance (PT-9) to protect the product from odor and to make odor control claim. Since this treatment doesn't have any impact on the human but gives a secondary biocidal benefit to the product, I have two questions in mind:
- Does this treatment change my MD product classification?
- Do we need to follow EU BPR labelling requirements for treated articles (label the product with the name of active substances)?

Thanks,