May 3, 2018

Major changes underway in the European medical device and IVD markets require manufacturers to keep up with many complex moving parts. Issues including implementation of the MDR and IVDR, ramifications of Brexit and tightening Notified Body requirements have resulted in a more challenging CE Mark certification process for many companies.

European medical device and IVD news summary May 2018Below, we provide a summary of Emergo European medical device and IVD regulatory coverage from the past several months to help current and prospective CE Mark holders stay abreast of current developments.

Eudamed and UDI developments

Unique Device Identification (UDI) and entry of medical device information into the Eudamed database will be key components of MDR compliance. Our coverage of Eudamed and UDI news includes:

Brexit impact for medical device companies in Europe and the UK

As Brexit negotiations between the UK and EU continue, effects of a British withdrawal from the Union on medical device and IVD manufacturers as well as their Authorized Representatives, Notified Bodies and other counterparties remain a major concern:

Notified Body relationships

How tighter European regulatory control over Notified Bodies as well as MDR and IVDR implementation have affected Notified Body relationships:

Additional medical device and IVD news for Europe

Other recent regulatory developments important to medical device and IVD companies active in Europe include:

Related EU regulatory resources from Emergo:

Author

  • Stewart Eisenhart

Related