Study with the several resources on Docsity
Earn points by helping other students or get them with a premium plan
Prepare for your exams
Study with the several resources on Docsity
Earn points to download
Earn points by helping other students or get them with a premium plan
Community
Ask the community for help and clear up your study doubts
Discover the best universities in your country according to Docsity users
Free resources
Download our free guides on studying techniques, anxiety management strategies, and thesis advice from Docsity tutors
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
Typology: Exams
1 / 20
This page cannot be seen from the preview
Don't miss anything!
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
