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Posted On: 05/04/2020 12:54:08 PM
Post# of 8452
Re: Pineywoods #2421
Last word was CE would be complete by the implementation date of the new rules, 5/26/2020
"The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry."
https://www.natlawreview.com/article/eu-medic...hat-s-next
EU screwed the pooch in the way they handled this regulation change, a lot of pissed device makers. 43% of device companies are pulling some devices from the EU Market due to the new regulations.
As of December 2019 the EU had only certified 7 of the promised 20 Notified Bodies that are authorized to handle the new CE regulations.
https://www.medtechdive.com/news/disruption-e...ds/564884/
"The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry."
https://www.natlawreview.com/article/eu-medic...hat-s-next
EU screwed the pooch in the way they handled this regulation change, a lot of pissed device makers. 43% of device companies are pulling some devices from the EU Market due to the new regulations.
As of December 2019 the EU had only certified 7 of the promised 20 Notified Bodies that are authorized to handle the new CE regulations.
https://www.medtechdive.com/news/disruption-e...ds/564884/
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