Medical Decice Final Flashcards
What makes up a technical file
1) Device Description and product specification
2) Labelling and operator Manual/ instructions for use
3) Design and manufacturing information
4) essential requirements checklist
5) Risk Management File
6) Verification and validation testing
7) Declaration of Conformity
What would be contained in a device description file
Brief device description, legal contract manufacturer details, product variations and configurations, Intended use of device
What would be contained in a product specification
Detailed technical description of each part of system kit, operating principles, design control
Device manual and schematics
Labelling and Operator
Manual/Instructions for Use
1) Final artwork for Owner’s Booklet/IFU 2) Quick Reference Guide 3) labelling on device and packaging (must include all languages)
Design and manufacturing information
Manufacturing process for product, quality management systems, technical drawings.
General overview of manufacturing process
List of components (complete list of all materials including bill of materials)
What is included in the essential requirements checklist
Table documenting each clause of the MDR/IVDR, the standards/guidelines we applied to demonstrate compliance to that clause and references to documentation that document
A list of standards applied in full (or in part), and descriptions of the solutions adopted to satisfy the safety requirements of the Regulations where standards have not been applied.
What is in the Risk management file
1) Risk analysis
2) Risk evaluation
3) risk control
4) evaluation of overall risk acceptability
What is verification and validation testing
Clinical evaluation (lit review / clinical data/ clinical trial)
Benefit/ risk evaluation
Test reports
Lab reports biocompatibility data
What is the Declaration of Conformity
The Declaration of Conformity is a one-page document on which
the manufacturer of a medical device, “declare” your “conformity” with
the GSPR of the European Medical Device Regualations.
If decide is class 2 or 3 then you need to include your CE and the notifying body.
Medical device definition
(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a
physiological or pathological process or state,
— providing information by means of in vitro examination of specimensderived from the human body, including organ, blood and tissue
donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
What is a a serious deterioration in state of health
• a) life-threatening illness,
• b) permanent impairment of a body function or permanent damage to a body
structure,
• c) a condition necessitating medical or surgical intervention to prevent a) or b
D) Any indirect harm as a consequence of an
incorrect diagnostic or IVD test result or as a consequence of the use of an
IVF/ART device when used within MANUFACTURER user guidelines
E) foetal distress, foetal death or any congenital abnormality or birth defects.
Does death or serious incident have to happen for it to count ?
No.
It’s just enough that incident associated with a device happened and the incident was such that should it happen again it would lead to death or serious deterstion in health.
Provide an example of Death/serious Deterioration in state of health
During implant. Bone screw snapped as a result it was exchanged for another one.
What adverse incidents have to be reported ?
death,
serious deterioration in state of health,
Device malfunctioned,
What is the timescale for reporting incidents ?
New Mdr
Serious public health - imeaditley but no later than 2 days after awareness by manufacturer.
Death or serious deterioration - IMMEDIATELY (without any delay that could not be justified) after the MANUFACTURER established a link between the device and the event but not later than 10 days.
Others “” no later than 15 days
