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Target Audience

  • NHS Clinical Scientists, Clinicians, Bioinformaticians
  • NHS Genomic Laboratory Hubs (GLHs) members

Other Third Party Audiences

The external audience for this document may include medical device regulators and associated agencies in the pursuit of medical device regulatory and standards certification including:

  • Competent Authorities (CAs) from within the European Union (EU), including the Medicines and Healthcare Products Regulatory Agency (MHRA); the United Kingdom (UK) CA;
  • Notified Bodies (NBs) from within the EU, such as BSI Group;
  • NHS Digital; the NHS IT regulator in England and Wales

This document may also be requested by existing and prospective Genomics England customers as part of their procurement process. All external distribution of this document must be approved by a member of the Quality Improvements and Regulatory Affairs team prior to circulation.