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If you do business in Europe, I heartily suggest you familiarize yourself – and quickly – with the changes in MDR 2017/745 and MDR 2017/746.
The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746) replaces the EU’s current Medical Device Directive (93/42/EEC) and EU’s Directive on active implantable medical devices (90/385/EEC).
It shifts regulation from the pre-approval phase (your path to CE Marking) to the entire product life-cycle.
This is what your peers said were their top concerns:
Full EU MDR implementation isn’t mandated until 2020, but I wouldn’t wait if I were you.
Labelling alone will be a headache, with a host of requirements that deviate from UDI regulations. Greatly abbreviating due to space (get the whole report at http://bit.ly/EU-MDR-Labelling-Compliance), note:
Thanks to my friends at PRISYM ID for the heads up.
That link again: http://bit.ly/EU-MDR-Labelling-Compliance
Design Controls webinar tomorrow, May 23.
I’m hosting a webinar with Jon Speer from Greenlight Guru at https://medgroup.biz/design-control. It’s free for all Medical Devices Group members. Replay and slides available for all who register.
There’s already more than 1,000 registered. Grab your seat now.
Make it a great week.
The good news? The requirements on how to perform your clinical trials don’t change much.
We wrote about the latter: https://www.factory-cro.com/news/clinical-investigations-changes-medical-device-regulation/
(And about PMS per MDR for class 1 devices: https://www.factory-cro.com/news/the-post-market-world-of-class-i-devices/ )
Beluh Mabasa Ginting
Robert van Boxtel
Ong Kean Seng
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