What if you imported a shipment of surgical masks or respitory filter masks and there were found to be non-compliant to the legislation, or even worse: counterfeit. You cannot sell them on the EU market as surgical masks or respitory filter mask. But, can you sell them as barrier mask (also referred to as 'community masks')? The answer is NO.
Why not? We give you 3 reasons:
- Any article that looks like a type of product (such as surgical masks), but in fact is not compliant with the legislation of that type of mask, is against the the law and the principle of product compliance. The general public is not aware of product legislation and expects a product to be compliant. So, by offering a non-compliant products, even under a different description, is incompatible with the law. Also (following the example of surgical masks) a surgical masks is classified as a medical device under current medical device directive 93/42/EEC and under the new Medical Devices Regulation (MDR) (EU) 2017/745 (read about the postponement here). Selling non-compliant masks result in a breach of law:
To sell congiously non-compliant masks without being able to proof compliance with a technical file and CE-marked product, this is considered as formal non-compliance. Also, signing a Declaration of Compliance (DoC), without underlying documentation can be considered as document fraud.
Examples of risks of a sub-standard mask:
- "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." (art. 5.1 MDR).
- Skin contact with hazardoud chemicals
- Breathing in of unwanted textile fibres
Selling non-compliant masks poses a lot of risk for your business as well as the health of persons using the non-compliant masks. Intentionally selling non-compliant masks may even result in criminal prosecution.
- The process for selling compliant products starts with a supllier that's able to provide reliable compliance information and documentation.
- Make a Technical File in the ProductIP platform
- Collect relevant compliance evidence for THAT product (the ProductIP platform will inform you which requirements to follow)
- Ensure that markings and instructions are up to standard for THAT product.
To help you get started with Surgical masks, respitory devices and Hand gel or Sanitising wipes, we have written free guidance documents.