The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …
GDPR: What is it and what does it mean for your clinical studies: Part II
This two-part blog serves to summarize Covance Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Covance Medical Device and Diagnostic Solutions through a review of the …
GDPR: What is it and what does it mean for your clinical studies: Part I
This two-part blog serves to summarize Covance Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Covance Medical Device and Diagnostic Solutions through a review of the …