Diagnostic Testing Services in the EU

Fri, Feb, 2023 | Uncategorized

Many of our US-based diagnostic testing clients are having Titan Solutions help them move into the EU marketplace. In order to commercialise in vitro diagnostic (IVD) in the European Union, a CE Mark certificate is needed. This certification verifies that a device...

IVDR: What You Need to Know about Europe’s Changing IVD Market – UPDATED

Fri, Sep, 2022 | News

  The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. This new regulation will introduce substantial changes in the sector as companies in the IVD...

IVDR: What You Need to Know about Europe’s Changing IVD Market

Fri, Sep, 2022 | News

  The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Updated...

CE Mark Process for In Vitro Diagnostic (IVD) Devices

Tue, Sep, 2021 | News

In order to commercialize in vitro diagnostic (IVD) devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for IVDs, which will soon change under the new In Vitro Diagnostic...