Overview
ISO/TR 19244:2014 - Guidance on transition periods for standards developed by ISO/TC 84 - provides recommended transition plans for standards covering devices for administration of medicinal products and intravascular catheters. It clarifies how manufacturers, notified bodies and regulators should treat new or revised ISO/TC 84 standards from the date of publication, addressing concepts such as grandfathering, transition period, and significant design change.
Key topics and requirements
- Scope: Applies across ISO/TC 84 series, including needle-based injection systems, sharps protection and containers, aerosol drug delivery, needle-free injectors, syringes, needles, intravascular catheters and ports.
- Grandfathering (marketed devices):
- Marketed devices that show acceptable post-market safety/performance may remain on the market without meeting the newest standard.
- Conditions: adequate post-market data and an annual updated risk assessment (see ISO 14971).
- If a device undergoes a significant design change, grandfathering should not apply and design verification to the latest standard is recommended.
- Non-marketed and new devices:
- Recommended that non-marketed devices be designed to the latest edition.
- New marketed devices should comply with the new standard no later than three years after publication; beyond that, regulators or notified bodies should not accept conformity claims referencing the previous version.
- Rationale:
- Transition periods allow time for test method development, validation, documentation updates, and regulatory approval coordination with Notified Bodies and Competent Authorities.
Practical applications
- Provides a clear, pragmatic approach for:
- Regulatory affairs teams planning conformity timelines after publication of a revised ISO/TC 84 standard.
- Product development and quality engineers performing design verification and validation.
- Risk managers conducting annual ISO 14971-based assessments to justify grandfathering.
- Notified Bodies and Competent Authorities assessing acceptance of legacy devices and design changes.
Who should use this standard
- Medical device manufacturers (R&D, QA/RA)
- Regulatory and compliance professionals
- Notified Bodies and auditors
- Design verification and validation teams
- Risk management specialists
Related standards
Key referenced documents include:
Keywords: ISO/TR 19244:2014, ISO/TC 84, transition periods, grandfathering, medical devices, administration of medicinal products, catheters, design verification, notified body, risk assessment.
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