Device-applicable legislation values

MDR Art 95 – Devices presenting an unacceptable risk to health and safety

MDR UNR

MDR Art 97 – Other non-compliance

MDR ONC

MDR Art 98 – Preventive health protection measures

MDR PHP

IVDR Art 90 – Devices presenting an unacceptable risk to health and safety

IVDR UNR

IVDR Art 92 – Other non-compliance

IVDR ONC

IVDR Art 93 – Preventive health protection measures

IVDR PHP

Regulation (EU) 2017/745 on medical devices (MDR)

MDR

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

IVDR

Council Directive 93/42/EEC on Medical devices (MDD)

MDD

Council Directive 90/385/EEC – Approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)

AIMDD

Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)

IVDD

MDR UNR

Y

N

Y

Y

N

MDR ONC

Y

N

Y

Y

N

MDR PHP

Y

N

Y

Y

N

IVDR UNR

N

Y

N

N

Y

IVDR ONC

N

Y

N

N

Y

IVDR PHP

N

Y

N

N

Y