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As many of you may already know Bag on Valve (BoV) is a versatile packaging solution, used for a variety of products, from food to medical barrier sprays.

A growing use for the Bag-on-Valve system is with medical products classified as drugs or over the counter medical devices. As opposed to traditional aerosols, BoV maintains your products integrity, keeping your product separated from the propellant at all times. Therefore, customers can trust the quality and consistency of the product when using BoV pharma and medical devices.

Product classifications

In the healthcare marketplace you find products that are classified as:

  • pharmaceuticals

  • herbal products

  • homeopathic remedies

  • cosmetics

  • biocides

  • medical devices

Pharmaceuticals contain active pharmaceutical ingredients (API) and achieve their principal action by pharmacological, metabolic or immunological means.

Medical devices, on the other hand, achieve their action by mechanical and physical means. They don’t contain API and don’t achieve their effects through chemical action within or on the body. BoV products that rinse, clean or create a barrier are typically classified as medical devices according to the European medical device regulations..

Difference between a medical device and pharmaceuticals

Bag On Valve Spray CanThere are borderline cases where it can be difficult to classify the product as a medical device or medicine. The correct classification is very important and will highly affect registration requirement, manufacturing and marketing throughout the product lifecycle.

Being classified as a medical device, rather than pharmaceutical, a product can reach the market much faster, and in the EU, an application for registration can be made once instead of the more complicated and costly drug application for pharmaceuticals. Registering an BOV-product as a medical device can provide a more cost-effective way of entering the European market

If you have any questions about BoV as a packaging alternative for healthcare products, leave a comment below or contact the Bag on Valve experts for more information.

 

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2 Comments

  1. Vanzembergh-Reply
    December 5, 2014 at 09:28

    Good afternoon,

    May I ask you what is the impact of this BOV technology on the medical device classification? So, a medical device using this technology is considered as an active device?
    I am thanking you in advance.
    Best regards,

    • December 15, 2014 at 03:25

      Most BOV products on the market are not classififed as active devices meaning that the packaging technology does not effect the classification. There are exceptions where the notified body has make another interpretetations of the rules and made it an active medical device based on the pressure in the can.
      regards / Magnus

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