IVDR Analytical Performance Studies

Surely you have heard about it: the IVDR, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. The good news is: there is a five-year transition period. But do you know how this affects you, and how you will make sure you are fully compliant by 2022? We have the expertise and experience to get you ready in time.

Important changes

With the IVDR we will see many changes in definitions, and it also has a wider scope. This means that products currently classified as an in vitro diagnostics device (IVDD), may require IVDR compliance. The IVDR also tightens the requirements for clinical evidence and conformity assessment. Technical documentation must contain the results and critical analyses of all design verification and validation tests – data must be collected in compliance with the harmonised standards and applicable Common Specifications.

How we can help you meet new IVDR requirements

We offer analytical performance services to ensure a smooth transition from the IVDD to the IVDR. As a first step, we will review your current technical documentation. We will determine which studies have already been reported, and assess their quality. Based on this, we will come up with tailored advise and, together, we will decide which additional studies are critical to demonstrate compliance. Then, while you as manufacturer can continue to focus on future developments, we will conduct the necessary analytical performance studies to ensure timely conformity of your assays with the IVDR.

 

 

Why choose Future Diagnostics' analytical performance services?

We are EN-ISO 13485 certified and our studies are designed to comply with EN 13612:2002, EN ISO 23640:2015 and applicable CLSI guidelines
We will tell you in advance what is required to comply with the IVDR, and do exactly that – nothing more
All your products will be IVDR compliant in time
Your team stays focused on their (development) activities
And..... you will enjoy total peace of mind

Find out more about how we can help you get ready for the IVDR.

We’d love to hear from you!

Contact us