September 25, 2022

[FEATURED] EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble for Manufacturers

Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the ­new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.

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September 19, 2022

[FEATURED] EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value

Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.

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September 13, 2022

[FEATURED] Much More Is Needed, Industry Says To EU’s 19-Point Regulatory Action Plan

The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this really the lifeline needed for the medtech industry?

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September 5, 2022

[FEATURED] Why EU Regulations Are Changing The Face Of Innovation And May Be Unsustainable

The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.

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August 30, 2022

[FEATURED] No Quick Fix When It Comes To EU MedTech Notified Body Designations

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

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[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

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