Regulatory Open Forum

Is the MD symbol (taken from ISO 15223-1:2021) required also for accessories Lebel?

Hi Anon,
I assume you are asking this question in scope of EU regulations.

By definition accessories to medical devices are not medical devices by themselves. They are referred as ‚devices' and requirements of regulation (EU MDR) apply.

As they are not medical device by themselves, indicating with MD does not apply for them, as that would be a contradiction.

Is the MD symbol (taken from ISO 15223-1:2021) required also for accessories Lebel?

Is the MD symbol (taken from ISO 15223-1:2021) required also for accessories Lebel?

If the accessory inherently meets the jurisdiction's official (i.e., statutory; legislative, etc.) definition of "medical device", such as the EU MDR's Article 2(1), then the symbol is appropriate and expected.  In that case, the "accessory" instead needs to just be categorized as a "medical device", not an accessory.

In contrast, the U.S. includes the term "accessory" in its statutory definition for device, in which case the MD symbol (if used at all for a U.S. label) would be expected for an accessory.

Canada's statutory definition of device, like the U.S.'s, includes "accessory", and thus would be handled like the U.S., where the MD symbol (if used at all) would be expected for an accessory.

Is the MD symbol (taken from ISO 15223-1:2021) required also for accessories Lebel?