Overview
ISO/TR 12417-2:2022 - "Cardiovascular implants and extracorporeal systems - Vascular device‑drug combination products - Part 2: Local regulatory information" is a technical report that provides region‑specific regulatory guidance for vascular device‑drug combination products (VDDCPs). It focuses on local submissions, approvals and the evaluation of changes related to the drug‑containing part (DCP) of VDDCPs. The report is a supplement to ISO 12417‑1 and ISO 14630 and is intended to support manufacturers and regulators dealing with both implanted and non‑permanent vascular combination products.
Key topics and technical requirements
- Scope and definitions: Clear terminology for VDDCP elements such as active pharmaceutical ingredient (API), drug product, device part (DP), drug‑containing part (DCP), batch, change and clinical event.
- Region‑specific guidance: Sections covering local regulatory expectations and submission pathways in major jurisdictions (e.g., Australia, Brazil, Canada, EU, India, Japan, PRC, Russia, USA), including:
- Managing changes
- Clinical evaluation requirements
- Audit requirements
- Change management: Practical framework for assessing changes that affect the DCP:
- Identify changes
- Perform risk evaluation
- Use guidance for change evaluation (including pre‑market considerations)
- Interaction with regional regulatory authorities for post‑commercialization changes
- Applicable documents: Lists and references to local guidance documents and standards that inform regulatory submissions and evaluations.
- Emphasis on evolving regulatory requirements - users are advised to consult local regulatory authority webpages for the latest rules.
Practical applications - who uses this standard
ISO/TR 12417‑2:2022 is valuable for:
- Medical device and combination product manufacturers preparing local regulatory submissions and managing post‑market changes for VDDCPs.
- Regulatory affairs and quality assurance teams establishing change control processes and risk evaluations for drug‑device combinations.
- Clinical evaluators and product development teams aligning clinical evidence and evaluation plans with local expectations.
- Notified bodies and regulatory authorities as a reference for harmonized terminology and for understanding common expectations across regions.
Related standards
- ISO 12417‑1 - General requirements for VDDCPs
- ISO 14630 - Non‑active surgical implants - General requirements
- ISO 25539 series - Requirements for endovascular devices
- Relevant regional guidance documents and national regulations (as listed in the report)
This technical report supports compliant product development, regulatory submission strategies and robust change‑management for vascular device‑drug combination products in global markets. Keywords: ISO/TR 12417‑2:2022, VDDCP, vascular device‑drug combination, local regulatory information, change management, clinical evaluation, device‑drug combination.