August 2, 2018

[FEATURED] Commission’s Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour

A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with the new regulations when they apply in 2020 and 2022. So, what is happening?

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May 4, 2018

[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?

“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be easier routes to compliance than companies think, according to attorney Joerg Schickert.”

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March 5, 2018

[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?

“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has been painfully slow. So, what is needed in 2018 to ensure the MDR and IVDR are viable?”

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November 13, 2017

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline

“European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.”

 

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