CE marking is the medical device or in-vitro diagnostics manufacturer’s claim that a product meets the essential requirements of all relevant EU Directives and is a legal requirement to place a device on the market in the European Union.

 

The European Parliament on April 5, 2017, adopted the MDR and IVDR proposed by the European Commission in 2012.   This will initiate a transitional period of May 2020 for medical devices and May 2022 for the IVD industry for full implementation of the new regulations.

 

This change will be particularly significant for the In-vitro diagnostics (IVD) industry as most of the IVD under legacy regulations were under self-certification.  As per the EU Commission, under existing rules only 1 out of 5 IVDs were checked by a Notified Body before placing them on the market, but new regulations may require 4 out 5 IVDs to be checked by a Notified Body.

 

AltaQ has significant expertise and network within EU to help manufacturers to these requirements in an effective and efficient manner.  Please click here to learn more about services and provide additional information based on your needs