Blueprint Genetics, a quality leader in genetic testing, embraces new EU regulation (IVDR)
At Blueprint Genetics, we consider patient safety and the effectiveness of our diagnostic service as our key priorities. This is reflected in the way we have chosen to comply with the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
On May 26 2022, the IVDR replaces the In Vitro Diagnostic Directive (IVDD) as legally binding regulation in the European Union (EU). The IVDR has been instituted to increase the safety and effectiveness of in vitro diagnostic devices and make the manufacturing and distributing of devices more regulated and transparent. At Blueprint Genetics, we are aligned with the new regulation from day 1 and the regulatory change will not affect the availability of our products in any way.
To be placed on the EU market, products covered by the scope of the European Union in vitro diagnostic (IVD) legislation must be affixed with the CE mark, which indicates conformity with the EU IVD legislation. This means that a clinical laboratory that has CE marked its tests has implemented manufacturer’s requirements, including a quality management system appropriate for IVD medical device design, development and manufacturing.
Blueprint Genetics has been a forerunner of CE marking, having offered CE-marked panels to its EU customers since 2017. As the regulatory landscape changes, however, the CE marked portfolio was expanded to cover the analysis platforms (Blueprint Genetics WES Platform and Blueprint Genetics CES Platform) to meet the needs of EU customers and regulators. As a result, all Blueprint Genetics Oy services including panels, single-gene tests, variant-specific testing and whole-exome sequencing will be analyzed using the CE marked platforms.
Given our longstanding commitment to quality and patient care, Blueprint Genetics is well positioned to adopt the requirements of the IVDR. Moreover, we will continue to offer a diagnostic service that does not merely meet regulatory standards but goes beyond in offering diagnostics that makes a difference in patient care.
For more information on the IVDR, please visit the European Commission’s website.
About Blueprint Genetics:
Blueprint Genetics, a Quest Diagnostics® company, is a leading specialty genetics and bioinformatics company focused on providing genetic testing for inherited diseases. The company is based in Helsinki and Seattle, with a customer base spanning over 70 countries. www.blueprintgenetics.com
Further information
Olli Mikkonen, Director, Quality & Regulatory, olli.mikkonen@blueprintgenetics.com