Sep 15, 2016
EMERGO SUMMARY OF KEY POINTS:
Major medical device and IVD regulatory developments have occurred in Europe over the past few months. From publication of Medical Device Regulations (MDR) and IVD Regulations (IVDR) to substantial updates to clinical evaluation requirements to ramifications of Brexit, here are some key European market updates:
For additional information and analysis on these significant European regulatory changes, download our whitepaper on the new MDR.
Publication of draft In Vitro Diagnostic Regulations (IVDR) in the European Union, which occurred earlier than anticipated, provides IVD manufacturers with a clearer idea of how new requirements will impact their CE Marking certification and compliance.
Now that the European Medical Device Regulation (MDR) is widely available, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.
A revision of European guidance MEDDEV 2.7.1, entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" was issued in December 2009.
In a stunning referendum on June 23, UK voters decided to leave the European Union (EU). This historic vote has many medical device companies – inside and outside the UK - wondering what the future holds for the regulation of devices and IVDs sold in the country.