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).

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