Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date?

prkpr

Registered
Hi Elsmar Community!

I am in the process of EU MDR compliance for Class I devices and there is a question on label updates per EU MDR Annex I Chapter 3. Per the new requirement we need an indication that the device is a medical device and we have chosen to go with the industry standard label symbol "MD". However, what I need help understanding is whether this label needs to be applied to all CE-marked (Class I) devices that have already been built and are currently in the inventory. To provide more details, these products are final finished devices (non-sterile) that have been packaged and labeled already. Will these require re-labeling?
 

mboynton

Starting to get Involved
Hi Prkpr,

The EU MDD/ EU MDR compliance switch applies depending on when devices are "first placed on the market," as defined in the EU MDR and as further elaborated in the Blue Guide. It is very possible that your packaged and labeled devices could have already been placed on the market in the EU, so long as 1) they have been imported to the EU; or 2) they have been manufactured in the EU, and have moved far enough along the supply chain that they could theoretically be sold out of their inventory location. If the devices have been placed on the market in this way, you should not be required to re-label.

One word to the wise, the "MD" symbol in the ISO 15223-1:2020 version of the standard has 1) not yet been formally released by standardization body ISO ( :2020 standard version is still in development), and 2) nor has it been harmonized to EU MDR, so it's worth considering whether/how you'll fulfill translation requirements into national languages for this GSPR, since the symbol doesn't take care of that by default absent its harmonization. If you've already got a plan for how to address that, I'd be curious to hear the solution that you've come up with!
 

prkpr

Registered
Thank you for the detailed response, mboynton. In the case at hand, we do not currently sell in Europe but maintain a CE Mark on the devices for business reasons. Therefore, the inventory I am referring to is not yet in the EU. Based on your comment, "The EU MDD/ EU MDR compliance switch applies depending on when devices are "first placed on the market,"", it looks like we will have to re-label any CE Marked devices in inventory (not in EU but in US) with an indication that it is a medical device - is this correct?

Also - I am curious what the purpose is of the indication that the device is a medical device - is it for customs? is it for physicians? is it for patients? This answer in my mind will answer my next question: Does the indication/symbol need to exist at all levels of packaging from the higher level package to the device primary package?

Thoughts, ideas, suggestions, concerns - all welcome!
 

Edward Reesor

Trusted Information Resource
I am also curious for the need for a MD symbol. Our contract manufacturer placed a MD symbol for us on our labels during an update request, however we only sell these products in North America. Is the MD symbol even required?
 
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