Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:3aa_4
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 3AA cl 4
Character Range: 460535–462481

4  Additional requirements
 (1) For the purposes of subclause 2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations) are taken to include the requirements mentioned in this clause.

Independence and impartiality
 (2) Section 1.2 of each EU regulation includes a requirement that an Australian conformity assessment body will take action:
 (a) to respond to any threats to its impartiality; and
 (b) to ensure that all internal or external personnel or committees who could influence the body's certification‑related activities will:
 (i) act impartially; and
 (ii) not allow commercial, financial or other pressures to compromise impartiality.

Liability
 (3) Section 1.4 of each EU regulation includes a requirement that an Australian conformity assessment body will:
 (a) document a justification for the cover and overall financial value of the liability insurance mentioned in that Section, including:
 (i) the types of medical devices and conformity assessment procedures in relation to which the body carries on certification‑related activities; and
 (ii) the locations at which those activities are carried on; and
 (iii) the patient risk profile of the devices; and
 (iv) the compliance risk profiles of the manufacturing activities in relation to which the body carries on certification‑related activities; and
 (b) give this justification to the body's liability insurer, and document having done so.

Process requirements
 (4) Section 4 of each EU regulation includes a requirement that an Australian conformity assessment body will have documented procedures in place that cover the following in relation to the body's certification‑related activities:
 (a) assigning internal or external personnel to activities on the basis of their documented competences;
 (b) following up corrections and corrective actions by manufacturers in relation to nonconformities identified during audits or assessments.