Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

All,

We have a marginal class I medical device in the EU. The same unit is not medical in other parts of the world. Does the MD symbol have to go on the product label or can it be a separate label applied during production?

Anon,

There can be different approaches in the scenario you described and depends on the packaging, how the product is being shipped, and distribution channels.  Many state the "MD" symbol needs to be on medical devices in the EU based on Annex I wording.  If the product is not a medical device in other jurisdictions, then honestly it might be beneficial internally to have different part numbers and different packaging.  Indeed there could be a separate label applied during production that would apply for medical designation and non-medical designation.  Again having finished device part numbers or packaging indications for the different versions.  It can be a little complicated, so might want to inquire about further assistance in your specific scenario.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
------------------------------

Original Message:
Sent: 20-Feb-2024 09:29
From: Anonymous Member
Subject: MD symbol label

This message was posted by a user wishing to remain anonymous

All,

We have a marginal class I medical device in the EU. The same unit is not medical in other parts of the world. Does the MD symbol have to go on the product label or can it be a separate label applied during production?

Hi Anon

One of the things that gets tricky is keeping track of what constitutes "the label". There may not be a rule saying that "the label" has to be a single adhesive paper. And during a physical inspection it's easy enough to see that all the required information is there, at least if your MD addendum is placed close to the rest of it. When you are requested to email a sample label copy for registration purposes or as part of a remote inspection, you will need to remember to send the whole label, including all the parts of "the label" that get applied separately.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 22-Feb-2024 06:06
From: Richard Vincins
Subject: MD symbol label

Anon,

There can be different approaches in the scenario you described and depends on the packaging, how the product is being shipped, and distribution channels.  Many state the "MD" symbol needs to be on medical devices in the EU based on Annex I wording.  If the product is not a medical device in other jurisdictions, then honestly it might be beneficial internally to have different part numbers and different packaging.  Indeed there could be a separate label applied during production that would apply for medical designation and non-medical designation.  Again having finished device part numbers or packaging indications for the different versions.  It can be a little complicated, so might want to inquire about further assistance in your specific scenario.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA

Original Message:
Sent: 20-Feb-2024 09:29
From: Anonymous Member
Subject: MD symbol label

This message was posted by a user wishing to remain anonymous

All,

We have a marginal class I medical device in the EU. The same unit is not medical in other parts of the world. Does the MD symbol have to go on the product label or can it be a separate label applied during production?