Regulatory Open Forum

Hello, 

I've seen part of the IVDR regulation related to batch release, but is there anything for MDR? If not, what would be the equivalent? 

Hello Anon

There are special rules for batch verification of devices that contain medicines or blood.

Apart from that, you're just expected to define what makes sense for your type of device, based on technical characteristics and risks - inspections, sampling, process validation and/or whatever

Plus, "It should be ensured that supervision and control of the manufacture of devices (is) carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification."

And "3.The person responsible for regulatory compliance shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;"