Month: March 2020

CE marking

2020-03-18

GAP Analysis: EU MDR Compliance

This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.

CE marking

2020-03-17

CE Marking Medical Device Standalone Software – MDR & IVDR Guide

The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.

CE marking

2020-03-12

Declaration of Conformity Guidance & Template

The EU Declaration of Conformity is a legal document, wherein a manufacturer formally declares the compliance of a product with the essential requirements of the relevant directives.

CE marking

2020-03-08

Medical Device Classification According to the MDR

Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.