Medicinal Product Medical Device

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How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Medical devices with an ancillary medicinal substance A medical device may contain an ancillary medicinal substance to support the proper functioning of the …

Quality documentation for medicinal products when used …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

This guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately-obtained and referenced in the product …

The combination of medical devices and medicinal products …

https://omcmedical.com/borderline-classification-of-combination-of-medical-devices-and-medicinal-products/

A medical device that uses substances as its base contains ingredients approved for use in medical devices and does not carry out its primary intended activity …

Understanding the borderline between medical devices …

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/understanding-the-borderline-between-medical-devices-and-medicinal-products/

Medical devices are regulated by the Medical Devices Regulation ( MDR) whereas medical products are covered by the Directives relating to medicinal …

Frontiers | Medicinal products, medical devices, or …

https://www.frontiersin.org/articles/10.3389/fdsfr.2022.1089965/full

On the other hand, in agreement with MPD (Art. 1.2), a medicinal product is “a substance, or a combination of substances presented as having properties for treating or preventing …

Borderlines between medical devices and medicinal …

https://www.gov.uk/government/publications/borderlines-between-medical-devices-and-medicinal-products

Borderlines between medical devices and medicinal products How to distinguish between products that are regulated as medical devices and those …

Cosmetic, medicinal product, Medical Device or Biocide?

https://biorius.com/regulatory/cosmetique-medicament-dispositif-medical-ou-biocide/

The boundary between a cosmetic, a medicinal product, a usual product and a Medical Device or a biocide can be blurry in many cases. You will find below some …

Combination Products and EU MDR …

https://www.qualitymeddev.com/2021/02/02/combination-products/

A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be …

MANUAL ON BORDERLINE AND CLASSIFICATION IN …

https://health.ec.europa.eu/system/files/2020-08/md_borderline_manual_05_2019_en_0.pdf

outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those …

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