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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December 11, 2017

[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions

US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This new guidance showcases useful flowcharts to help device sponsors determine when a new 510(k) submission will be needed for their product. The FDA states that “when evaluating a change in device and the need for a subsequent new 510(k) that requires an evaluation by agency staff, the agency ‘shall only require the “minimum required information” necessary to support a determination of substantial equivalence.’ “

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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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October 30, 2017

10 Implications to Medical Device Companies caused by the MedDev v4 Requirements

Medical device industry standards are in constant flux. Standards are frequently updated to meet conformity requirements. So what are the clinical requirements that you need to be aware of to stay compliant? (more…)

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MedTech Summit 2019

June 17-21, 2019

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