COVID-19

EU MDR Delays

EU MDR Delays

It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.

EU MDR Common Specifications Are Not Common

EU MDR Common Specifications Are Not Common

A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).

COVID-19 Fraudulent Products

COVID-19 Fraudulent Products

It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure...

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