Medical Device Ancillary Medicinal Product

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Medical devices with ancillary medicinal substances

https://www.bsigroup.com/en-US/medical-devices/Technologies/device-drug/

Examples of Ancillary Medicinal Substances include: Gentamycin, Human Serum Albumin Chlorhexidine Fluoride Lidocaine Thrombin, Growth Factors, recombinant peptides Heparin Silver, Triclosan, Polyhexanide, Idoine

Medical devices | European Medicines Agency

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

Examples of medical devices with an ancillary medicinal substance include: drug-eluting stents; bone cement containing an antibiotic; catheters coated with …

Medical devices with ancillary medicinal substances | BSI

https://www.bsigroup.com/en-GB/medical-devices/technologies/device-drug/

A Notified Body for medical devices with ancillary medicinal substances. BSI recognises that regulatory requirements for manufacturers of medical devices incorporating medicinal substances can be challenging. BSI …

Consultation procedure for ancillary medicinal …

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices

The specific fees applicable to consultation procedures on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device can be found in …

The combination of medical devices and medicinal products …

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

The combination of medical devices and medicinal …

https://www.sciencedirect.com/science/article/pii/S0378517321007985

Medical Devices Guidance Document - Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary …

Medical Devices with Ancillary Medicinal Substances

https://www.celegence.com/medical-devices-ancillary-medicinal-substances-combination-product/

Defining A Medical Device – EU MDR. A ‘medical device’ is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for …

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/

Products used in vivo or ex vivo to distinguish between healthy and pathological tissue meet the definition of “medical diagnosis” and are regulated as …

Medical Device - Public Health

https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020-12_guidance_transitional_provisions_en_0.pdf

Medical Device Coordination Group Document MDCG 2020-12 Page 2 of 6 Guidance on transitional provisions for consultations of authorities on devices incorporating a …

MANUAL ON BORDERLINE AND CLASSIFICATION IN …

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

medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device …

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