Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

The Borderline and Classification Working Group has just published on the European Commission website the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The above-mentioned allows stakeholders to determine the qualification of borderline products by stating whether it is a medical device or an in vitro diagnostic medical device or another type of product (medicine, cosmetic, etc.) This manual also specifies, where applicable, the classification rule that should apply to medical devices or in vitro diagnostic medical devices.

For instance, the following are mentioned:

• Ethylene oxide gas cartridges (sterilant)
• Smartphone applications for STI prevention strategies
• Implantable dermal fillers
• Nasal sprays with antibodies for COVID-19

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