Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities.
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Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities.
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Regulation (EU) 2017/746 (IVDR ...... arket surveillance activities.
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66,540,149
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made
2017-04-05
OJref
OJ L 117, 5.5.2017, p. 176–332
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replaces
Directive 98/79/EC regarding in vitro diagnostic medical devices
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status
current
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title
type
Regulation
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comment
Regulation (EU) 2017/746 (IVDR ...... arket surveillance activities.
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label
Regulation (EU) 2017/746
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