Welcome to another blog in our ongoing series, Ask Lewis Bass!

This series features actual submitted questions from companies in the industries we provide engineering safety consulting services to.

Topics covered include those associated with our work in 3rd party field labeling, SEMI S2/S8/EMC/F47 testing, CE Marking evaluations, and general engineering questions.

Question:

Hi Lewis Bass,

Hey Lewis, I’ve recently come across an interesting situation. Our company manufactures medical devices that are originally intended for human use, but now there’s been interest in repurposing some of these devices for veterinary use. Do we need to obtain separate CE marking for these repurposed products, even though they are the same devices, just used in a different context? Any guidance on this would be greatly appreciated!

Asked by Edgar in Santa Cruz, CA

Lewis Bass:

Hello Edgar,

Great question! Repurposing medical devices from human to veterinary use presents a unique challenge in terms of regulatory compliance, and I’m happy to shed some light on the topic.

First, let’s clarify what CE marking represents. When a medical device is CE marked for human use, it has undergone rigorous testing and compliance with specific standards set out by the Medical Device Regulation (MDR). This includes safety, performance, and overall conformity to essential health requirements. However, veterinary devices do not fall under the MDR but are instead governed by the General Product Safety Directive (GPSD) or Veterinary Medical Devices Directive, depending on the product type.

Here’s where things get tricky: While the devices themselves may be identical, their intended use has changed. This shift from human to veterinary use means the CE compliance you originally obtained for human use is no longer valid for the new context. You’ll need to reassess the product under the relevant regulations for veterinary devices. This might involve additional testing or certification, depending on how the device is classified under veterinary rules.

To answer your question directly: Yes, you will need to obtain new CE compliance for the repurposed devices, as the original CE marking doesn’t automatically transfer across different uses, even if the product itself remains unchanged. It’s all about the intended application, and the rules are in place to ensure safety in the context of the new use. Be prepared to go through a new conformity assessment process based on the regulations that apply to veterinary devices.

In summary, while it may feel like the same device, the regulatory path changes due to the shift in its application. Achieving CE compliance for veterinary use will ensure that you meet the necessary safety and performance standards, just as you did for human use. And hey, on the bright side, once you’ve got that covered, you’ll be in a great position to expand your market!

If you have more questions on CE compliance, feel free to reach out!

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