Borderline Medical Device Medicinal Product

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Borderline products: how to tell if your product is a medicine

https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine

The types of products which may fall into the borderline category include: cosmetics food products, including, in particular, food supplements herbal products biocides machinery/laboratory...

Understanding the borderline between medical devices …

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

Borderline products are those where it is not clear whether they fall under the MDR or the MPD. In order to fall under the MDR, a product has to: Meet the definition of …

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/

Borderline medical devices and Combination Products. The MDCG 2022-5: “Guidance on borderline between medical devices and medicinal products under …

The combination of medical devices and medicinal products …

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

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 …

Guidance MDCG 2022-5 on borderline between medical devices …

https://lne-gmed.com/news/guidance-mdcg-2022-5-on-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2017-745

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation between the two legal …

MDCG 2022-5 - Guidance on borderline between medical …

https://health.ec.europa.eu/latest-updates/mdcg-2022-5-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2022-04-26_en

MDCG 2022-5 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices Details …

New MDCG 2022-5 Guidance on Borderline between Devices …

https://namsa.com/new-mdcg-2022-5-guidance-borderline-between-devices-drugs-mdr/

In late April 2022, the long-awaited Medical Device Coordination Group (MDCG) guidance on borderline devices under the Medical Device Regulation (MDR) …

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 but …

MDCG 2022 guidance on borderline product. - Operon Strategist

https://operonstrategist.com/mdcg-2022-guidance-on-borderline-product/

This document discusses about the borderline between the medical device (MDR) and medicinal product (MPD). It also provides the relevant definitions and …

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