The extended transition period applies only to ‘legacy devices’, i.e., those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before May 26, 2021, as in:
IMPLANTABLE CLASS IIb and CLASS III Devicesà December 31, 2027
WELL-ESTABLISHED CLASS IIb*, CLASS IIa, CLASS Im, Is and Ir DEVICESà December 31, 2028. (*Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors).Furthermore, this provision adapts Articles 122 and 123 MDR to reflect the extended transition period and the 𝗱𝗲𝗹𝗲𝘁𝗶𝗼𝗻 of the ‘𝘀𝗲𝗹𝗹-𝗼𝗳𝗳’ deadline.
The provision also includes amendments in Articles 110(4) and 112 of the IVDR. As a result, IVD devices placed on the market before 26 May, 2022 can be made further available on the market and put into service without a legal time restriction.
What´s next? The transition will become law as soon as it is published in the European journal.
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