Borderline Products Medical Devices

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

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

The types of products which may fall into the borderline category include: medicines herbal medicinal products cosmetics biocides personal protective equipment machinery/laboratory equipment...

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 …

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 …

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

There is also a borderline between medicinal products and medical devices, both of which have medical purposes. In these cases, it will be the claims being …

Manual on Borderline and Classification in …

https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2022-2022-09-07_en

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022) General publications 7 September …

Manual on borderline and classification for medical devices …

https://health.ec.europa.eu/system/files/2022-09/md_borderline_manual_09-2022_en.pdf

The aspects concerning the borderline between medical devices and other types of products, also known as qualification of a product, are generally governed by Article 4 …

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 …

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

This document, developed by an expert working group, aims to support a uniform implementation of the MDR across the EU and may be revised to reflect up-to …

Borderline considerations: medicinal products, medical devices ...

https://uk.practicallaw.thomsonreuters.com/Document/I9b94b4e8020b11eaadfea82903531a62/View/FullText.html?contextData=(sc.Default)

A practice note setting out key EU and UK law and guidance in relation to borderline products in the life sciences sector. The borderlines explored in this note are those …

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