RAC devices EU 2024 | Questions with
100% Correct Answers | Verified | Latest
Update 2024| Graded A+
what devices do notified bodies review? - ✔✔class 1 and 2: sterile or
measuring function. only look at those aspects
class 3: examine product design and quality system
post market review - ✔✔must monitor
determine if benefit risk profile has changed and fix if needed. if they don't do
a necessary fix, marketed illegally
report adverse events
how are custom devices regulated? - ✔✔exempt from conformity assessment
can't have CE mark
essential requirements in MDD
must have quality system
,clinical investigation device - ✔✔not allowed to have CE mark
reduced conformity assessment
record location of all investigational devices
only to be used in clinical investigation according to investigation protocol
EU MDR - ✔✔new medical device regulation
replaced existing device directive and active implantable device directive
EU IVD - ✔✔replaced IVD directive
general safety and performance requirements - ✔✔common
specifications required for a device type
may be met by using standards
demonstrate conformance before CE marking
notified bodies will review this info
, udi - ✔✔unique device identifier
used for reporting serious incidents and field safety corrective actions
doesn't apply to ide or custom devices
will link to Eudamed database
provided in patient info for implants
Reprocessing - ✔✔regulated at a member state level
Advanced Manufacturing - ✔✔followes the same rules as CE marked devices
HCF is responsible for post market surveillance
can only be used by the legal entity in which they are manufactured
must demonstrate that the needs of the patient can't be met by a CE marked
devices
official journal - ✔✔where the updated list of harmonized standards
are published
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