CASE STUDY:

JiT (Just in Time) Certification for ISO 13485

CE Marking is required for all in vitro diagnostic (IVD) devices sold in European Union (EU). CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC). Europe’s new In Vitro Diagnostic Regulation (IVDR) for European market access will come into force in 2022. The new IVDR brings substantial changes to the regulatory requirements for IVDs. ECM can provide critical information and guidance regarding the transition from the IVD to IVDR.

Please note that significant changes to this process will occur once Europe enforces the new In Vitro Diagnostic Regulation (IVDR). Download a copy of the IVDR.

ECM is not currently a Notified Body for the IVD Directive, however, we have applied for this designation under the new IVDR. We expect to be designated sometime in late 2019

View the latest information from the EU Commission here