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Delayed Implementing Regulation On Annex XVI Common Specifications Finally Adopted

 
• By Amanda Maxwell

While delays with aspects of the implementation of the Medical Device Regulation are all too familiar, threat of action at European Court of Justice level is unprecedented. But such measures have paid off for manufacturers of non-medical devices.

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Manufacturers of medical devices that come under the scope of the Medical Device Regulation (MDR) but that do not have an intended medical purpose will now have an opportunity for their products to be CE marked in the context of the regulation for the first time.

This is following news that the European Commission’s Implementing Regulation laying down common specifications for groups of products without an intended medical purpose has been adopted by the commission’s Committee...

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More from Geography

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

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Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel