Company: PSTV
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047698
Chunk: 60

Company: PLUS THERAPEUTICS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 60
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 a medical device and should be CE-marked under the EU medical devices legislation. 

Revisions of the EU regulatory framework: The EU pharmaceutical legislation is currently under review. On April 26, 2023, the European Commission published its proposal to revise the EU pharmaceutical legislation, consisting of a new Directive and a new Regulation, which would revise and replace the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicinal products for pediatric use and on orphan medicinal products (Regulation 1901/2006 and Regulation 141/2000/EC, respectively). Therefore, the provisions governing medicinal products in the EU may change in the future. The legislative process is ongoing and the final texts of the new acts are still unknown. Adoption is currently expected to occur in 2026, with implementation following thereafter.

EU in vitro diagnostic medical device legislation: In the EU, in vitro diagnostic medical devices (“IVD”) must currently comply with the General Safety and Performance Requirements laid down in Annex I to the In Vitro Diagnostic Devices Regulation (“IVDR”). Compliance with these requirements is a prerequisite to be able to affix the CE mark on products, without which they cannot be marketed or sold in the EU. To demonstrate compliance with the General Safety and Performance Requirements of the EU IVDR and obtain the right to affix the CE mark, IVD manufacturers must undergo a conformity assessment procedure, which varies according to the IVD’s classification. Apart from low risk medical devices (Class A non-sterile), in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the General Safety and Performance Requirements, a conformity assessment procedure requires the intervention of a notified body, which is an organization designated by a Competent Authority of an EU Member State to conduct conformity assessments. Depending on the relevant conformity assessment procedure, the notified body would audit and examine the technical documentation and the quality system for the manufacture, design and final inspection of the IVDs. The notified body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure conducted in relation to the IVD and its manufacturer and their conformity with the General Safety and Performance Requirements. This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its IVD after having prepared and signed a related EC Declaration of Conformity. Notified bodies must be designated by the authority responsible for notified bodies in the relevant