EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.110: Transitional provisions (Article 110 as amended by (EU) 2024/1860)

Article 110 as amended by (EU) 2024/1860 sets the transitional periods for legacy IVDs (devices already on the market under Directive 98/79/EC before 26 May 2022). Legacy devices with notified-body certificates issued under 98/79/EC may continue to be placed on the market until the certificate expires + 2 years (max). For self-declared devices under 98/79/EC, the staggered transition extends to: Class D devices until 31 December 2027; Class C devices until 31 December 2028; Class B + sterile-A devices until 31 December 2029. Article 110(3a) (added by 2024/1860) imposes a 'placing-on-the-market' notification obligation for manufacturers benefiting from the transition (6 months before the transitional deadline). Devices on the market before transition continue to be made available + put into service per Article 110(4).

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • MDR-Art.120 Transitional provisions (Article 120 as amended by (EU) 2023/607)

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.