Diagnostics for the Real World (Europe) Ltd.

Devices must conform to ISO 13485, harmonized standards, and national regulations before release. Technical documentation and EU declaration of conformity must be up-to-date. Post-market surveillance must comply with Article 10(9) of Regulation 2017/746. Reporting obligations in Articles 82-86 of the 2017 IVD Directive must be fulfilled. For performance studies involving risks, the statement in Section 4.1 of Annex XIV (Regulation 2017/746) must be issued.

Devices must conform to ISO 13485, harmonized standards, and national regulations before release. Technical documentation and EU declaration of conformity must be up-to-date. Post-market surveillance must comply with Article 10(9) of Regulation 2017/746. Reporting obligations in Articles 82-86 of the 2017 IVD Directive must be fulfilled. For performance studies involving risks, the statement in Section 4.1 of Annex XIV (Regulation 2017/746) must be issued.

Devices must conform to ISO 13485, harmonized standards, and national regulations before release. Technical documentation and EU declaration of conformity must be up-to-date. Post-market surveillance must comply with Article 10(9) of Regulation 2017/746. Reporting obligations in Articles 82-86 of the 2017 IVD Directive must be fulfilled. For performance studies involving risks, the statement in Section 4.1 of Annex XIV (Regulation 2017/746) must be issued.