PLEASE SHARE

   
 
09 Dec 2019

Class 1 MDR Self-certification re CE Mark extended 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 ...
Read More
11 Oct 2019

MDR IVDR Deadlines, Crash-out Brexit and other disrupters

MDMS, iso 13485, MDR, IVDR

 
Read More