Regulatory Open Forum

Annex I (23.2)(g) does not stand alone. The "as appropriate" depends on how you control the manner of production. If it is by ...

I agree with the longstanding adage that, if there is no lot number or serial number, then a manufacturer may need to recall a ...

Anon, This is a basic Good Manufacturing Practice (GMP) requirement/expectation which has been in place for many years. While ...

This message was posted by a user wishing to remain anonymous Is a lot number or serial number on the label always required ...

This message was posted by a user wishing to remain anonymous Note that the device you have identified provides quantitative ...

This message was posted by a user wishing to remain anonymous hi, I think many EU IVD manufacturers are currently struggling ...

This message was posted by a user wishing to remain anonymous As the title says, can a new (and initial) PCCP be included as ...

This message was posted by a user wishing to remain anonymous Hi Ronald Thank you for your input. Agreed. Always a smart ...

This message was posted by a user wishing to remain anonymous Hi Christoph, Thank you for this very comprehensive explanation ...

This message was posted by a user wishing to remain anonymous Thanks Dan, makes sense.