Medical Device Medicinal Product

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Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research programs, epidemiology,...

Medical devices | European Medicines Agency

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

Jan 25, 2023

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

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …

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 products …

The combination of medical devices and medicinal products …

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

Medical devices with an ancillary medicinal product built in as a component Clove Oil (Caryophylli aetheroleum) – has antiseptic, analgesic, and sedative …

Borderlines between medical devices and medicinal …

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

While there are other ‘borderlines’ with medical devices (for example with cosmetics, personal protective equipment, biocides etc) this guidance focuses on 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 information) …

Guidance on borderline medical devices & medicinal products

https://www.eclevarmedtech.com/en/mdcg-2022-5-guidance-on-borderline-medical-devices-and-medicinal-products-under-regulation-eu-2017-745-on-medical-devices/

Medical device composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the …

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 …

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