EU conformity assessment Flashcards
1
Q
Which sample of Class IIb devices are required to have for type examination?
A
One representative device per generic group
2
Q
Which type of sample are required as representative for Class IIa devices?
A
One representative of device for each category of device
3
Q
Who is responsible for regulatory compliance who possesses the requisite expertise as per MDR and IVDR?
A
PRAC (Person Responsible for Regulatory Compliance)
