Medical Devices Class Ir – Transitional Provisions to MDR
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Medical Devices Class Ir – Transitional Provisions to MDR

BySylvie

It is not easy to follow how and when to apply the new future MDR, a big pressure has been set on the class I reusable medical devices manufacturer to be ready to transition, yes but by when? Well back in July, the rules have changed again but are offering a longer transition period –…

Medical Devices Clearances maybe waived for hundreds of devices in 2021 through an international tender in Mexico!

BySylvie

This is the first time the Mexican Government opens a window for international manufacturers, even if they do not have sanitary registration approvals in Mexico. By Veraque; As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender…

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GMED designated under Regulation (EU) 2017/745 on medical devices

BySylvie

GMED official publication on linkedin: GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM). Equipped with this designation since July 8 2020, GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation…

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Medical Devices – Harmonized Standards MDD – New Listing

BySylvie

In March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.