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Join us on Wednesday, April 26th, 2017, 2 PM EDT as LNE/G-MED North America Inc. will be hosting a free informative session on the Medical Device and In Vitro Diagnostic regulations, the common changes and timelines introduced by the regulations, and what impact can manufacturers expect.

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The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in 2008 when the EU commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was first released by the European commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current medical device directive (93/42/EEC), the EU’s directive on active implantable medical device (90/385/EEC), and the In Vitro Diagnostic directive 98/79/EEC.

The final publication for both regulations is expected for no later than May 2017. The manufacturers will phase out from the respective directives governing their currently approved medical devices through a transition period of three years and fully embrace the requirements of the MDR, which will take full effect in 2020.The same is expected for In Vitro Diagnostic Medical Device Manufacturers with a transition period of 5 years, and the IVDR becoming enforceable by the end of 2022.

You can tune in to LNE/G-MED North America’s upcoming free webinar and hear Sheena Bond, IVD specialist, Auditor and IVD Technical File Assessor and Sam Shakir, Certification Project Manager, discuss the new Medical Device and In Vitro Diagnostic regulations.

 

About the presenters:

Sam Shakir LNE GmedSam Shakir

Certification Project Manager

LNE/G-MED North America, Inc. 

Sheena Bond LNE GmedSheena Bond

IVD specialist, Auditor and 

IVD Technical File Assessor

LNE/G-MED North America, Inc. 

 

 

REGISTRATION DETAILS
Calendar Notified Body 04 26

Topic: The Medical Device and In Vitro Diagnostic regulations: Key changes, transition and impacts for Medical Device manufacturers

Date: Wednesday, April 26th, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time

Click here to Register!

MDSAP Prepare the transition, worldwide market access

Combo Training ISO13485 MDSAP

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

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