Device-applicable legislation values
Procedure types:
Procedure type description | Procedure type |
---|---|
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 |
Applicable legislation:
Label | Abbreviation |
---|---|
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 |
The system will limit available applicable legislation values for non-registered devices based on procedure type. Only combinations marked ‘Y’ presented in the Procedure type/Applicable legislation table will be available for the user.
Procedure type / applicable legislation:
Procedure type | MDR | IVDR | MDD | AIMDD | 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 |