Blue Guide Medical Devices

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The Blue Guide on the implementation of the product rules 2022 …

https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en

The Blue Guide is a non-binding instrument and it was published in 2000. It has been subsequently updated twice, in 2014 and 2016. The current revision is a substantial update and takes into account developments that have come up since 2016, …

MDCG 2021-27 - Public Health

https://health.ec.europa.eu/system/files/2021-12/mdcg_2021-27_en.pdf

European Commission’s ‘Blue Guide’5 based on the principles of the New Legislative Framework6, and further complementary medical devices sectorial guidance …

Updated Blue Guide and MDR and IVDR harmonized standards

https://mdi-europa.com/updated-blue-guide-and-mdr-and-ivdr-harmonized-standards/

The Blue Guide is a horizontal guidance document that clarifies concepts like placing on the market, principles of CE marking and other essential aspects. It …

The new Blue Guide 2022 – not much new for devices and IVDs, …

https://medicaldeviceslegal.com/2022/08/04/the-new-blue-guide-2022-not-much-new-for-devices-and-ivds-but-certainly-more-confusion/

The new Blue Guide is here | medicaldeviceslegal

https://medicaldeviceslegal.com/2014/04/08/the-new-blue-guide-is-here/

To me the Blue Guide from 2000 has been immensely helpful for interpretation of crucial concepts in medical devices legislation, like ‘manufacturer’, ‘authorized …

Updates To The EU Blue Guide: Impacts on Market Surveillance …

https://www.citemedical.com/eu-blue-guide-impacts-on-market-surveillance-pms-of-medical-devices/

The Blue Guide is a way for the European Commission to give manufacturers and other economic operators a better understanding of EU product …

New Blue Guide - What is the impact on Medical …

https://podcast.easymedicaldevice.com/194/

The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of …

Importers – The European Union Medical Device …

https://eumdr.com/importers/

(For more information see also: ‘Blue Guide’ on the implementation of EU product rules.) The importer is responsible for making sure that the devices they place on the market …

EUR-Lex - C:2022:247:TOC - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES. European Commission. 2022/C 247/01. Commission notice …

The European Commission published the revised ‘Blue …

https://european-accreditation.org/the-european-commission-published-the-revised-blue-guide-on-the-implementation-of-eu-product-rules-2022/

The Guide to the implementation of directives based on the […]

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