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regulations - ✔✔legally binding and directly enforceable directives - ✔✔legally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - ✔✔directive 93/42/EEC includes essential requirements for safety but not technical specs where are technical specifications located? - ✔✔standards
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regulations
products manufactured in line with standards are assumed to meet essential requirements list of harmonized standards punished in the official journal in vitro diagnostoc device directive (IVDD) - ✔✔directive 98/79/EC essential requirements - ✔✔safety requirements that devices must meet outlined in MDD CE Mark - ✔✔manufacturer can self certify for just devices must have technical file demonstrating conformity
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
ISO 13485 - ✔✔qsr standard in EU class 1 devices - ✔✔low risk devices generally CE mark themselves all non-invasive devices unless another rule applies sterile or measuring: notified body reviews these parts of the device Class 2 devices - ✔✔medium risk design and manufacturing reviewed by notified body
includes all devices for storing/channeling body fluids/organs/cells/tissues e.g. blood bags class 3 devices - ✔✔high risk devices requires design and manufacturing review by notified body not classified devices - ✔✔not CE marked: custom made IVD authorized at the national level for public safety (e.g. EUA type devices)
who determines classification - ✔✔manufacturer notified body must agree if applicable if notified body disagrees go to competent authority and discuss with medical device coordination group results included with borderline products IVD hospital exemption - ✔✔tests and reagents developed in a hospital can be used in that hospital would complying with the IVDD IVD device classes - ✔✔class A: general lab products (buffers, specimen recepticales, etc) class B: self testing devices e.g., pregnancy, ovulation, glucose class C: detection and management of life threatening diseases, disease staging, genetic testing, pregnancy screenings class D: detecting transmissible agents in blood
what class of IVD requires notified buddy review? - ✔✔class B and up which device classes require clinical data? - ✔✔all of them can be from literature how often does a clinical evaluation report have to be updated? - ✔✔for as long as the device is marketed when they get new info risky/new device: annually established/not risky device: every 2 - 5 years can prescription medicines be advertised to the public? - ✔✔no
what is in the official european journal? - ✔✔proposed and final EU legislation emc directive - ✔✔2004/108/EC directive 93/42/EEC - ✔✔MDD directive number when can a clinical investigation begun for a class 1 devices with ethics committee approval? - ✔✔immediately class A and B devices - ✔✔IVDs lowest risk must have QMS without design controls
must have adverse event reporting have STED ready to go closest to class 1 IVD in USA class C devices - ✔✔IVD have full QMS must have adverse event reporting STED reviewed enough to determine conformance with essential principles closest to class 2 IVD in USA
e.g., wound dressings device classification rule 2i topic - ✔✔noninvasive devices for channeling or storing liquids/gases for introduction into the body administration sets, syringes device classification rule 2ii topic - ✔✔noninvasive devices for channeling or storing blood or other tissues blood bags, blood admin sets device classification rule 3 topic - ✔✔non-invasive devices for modifying blood or other fluids ECMO, dialysis
device classification rule 4 topic - ✔✔all other non-invasive devices don't contact patient or intact skin only urine collection bottles, hospital beds device classification rule 5 topic - ✔✔invasive devices through an orifice not to be connected to an active device exam gloves, urinary catheter, contacts dentures device classification rule 6 topic - ✔✔surgically invasive devices intended for transient use
low risk doesn't require notified body review IVD list B-D - ✔✔under IVDD increasing levels of risk requires notified body review how long to wait after notifying competent authority before beginning clinical trial - ✔✔60 days field safety corrective action (FSCA) - ✔✔an action taken by a manufacturer to reduce risk of death or serious injury associated with use of the device
ISO 14971 - ✔✔standard for risk management iso 9001 - ✔✔very old standard for QSR directive 90/385/EEC - ✔✔Active medical device directive of 1990 when can a clinical investigation begin for a class 1 devices with ethics committee approval? - ✔✔immediately after the date of notification a company is performing routine site monitoring for a clinical study and finds one site has not concerned 1/3 of it's subjects properly. what is the first thing the company needs to do? - ✔✔re-consent all improperly consented subjects record jerking requirements for marketed products are intended to provide assurance of which of the following? - ✔✔traceability in distribution