RA_QA_Expert
Involved In Discussions
Hi all,
based on MDR transitional period, class I MD placed on the market according to MDD before DoA (26.5.21) can be make available on the market (distributed) until May 2025. And some manufacturers take strategy to produce devices on stock (of distributors).
What about Software as Medical Device?
SaMD cannot be produced on stock physically, so if last version of SaMD is released in compliance with MDD and legally placed on the market before DoA, can manufacturer or distributor sells copies of this SW until 2025? Or?
Thank you for you thoughs
based on MDR transitional period, class I MD placed on the market according to MDD before DoA (26.5.21) can be make available on the market (distributed) until May 2025. And some manufacturers take strategy to produce devices on stock (of distributors).
What about Software as Medical Device?
SaMD cannot be produced on stock physically, so if last version of SaMD is released in compliance with MDD and legally placed on the market before DoA, can manufacturer or distributor sells copies of this SW until 2025? Or?
Thank you for you thoughs