09 Dec 2019

Class 1 MDR Self-certification re CE Mark extended by 4 years

MDMS, iso 13485, regulatory affairs, MDR

The European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday voted to adopt Corrigendum 2 to the Medical Device Regulations (MDR) that will give manufacturers of certain up-classified Class I devices an additional four years to comply. Corrigendum 2 to MDR was published on Nov 25th and it modifies Article 120(3) of MDR that now reads: '3. By way of derogation ...
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11 Oct 2019

MDR IVDR Deadlines, Crash-out Brexit and other disrupters

MDMS, iso 13485, MDR, IVDR

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