Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape. - PubMed - NCBI

Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape. - PubMed - NCBI

Eur J Health Law. 2015 Dec;22(5):463-80.

Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape.

Slokenberga S.

Abstract

Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet in the form of direct-to-consumer genetic testing. In the EU, the IVD Directive has been animadverted for its inability to tackle the challenges direct-to-consumer genetic testing has posed. Currently, the EU legislation is in a transition state. It is thus, timely to assess, to what extent the proposed IVD Regulation is intended to address the performance requirements and utility of direct-to-consumer genetic tests, which are made available to consumers within the EU over the Internet, and discuss the developments vis-à-vis the IVD Directive. To compare with the IVD Directive, the IVD Regulation presents a major shift in how direct-to-consumer genetic testing is treated in the E U. It remains unclear, whether and how the EU requirements can be applied beyond the EU market.

PMID:

 

26665691

 

[PubMed - in process]