6 Flashcards
Waarom hangt de acceptability van een innovation af van de designer
Morality is only warranted if we take responsibility for our innovations
and realize that technology is never neutral, but always value-laden
Wat zijn voorbeelden van Regulations and European directives (Law)
EU General Product Safety Regulation
Medical Device Regulation
Waaruit bestaat product safety
Technical orientated: Law
Legal and policy orientated: Ethics: norms and values
Human orientated: Human factors: Human error, unintended use and bias
Wat zijn European directive en regulations
Directive: EU law that sets out a goal or result that all EU member states must achieve but states can decide how they want to do it (European law: interpretation National law: act)
Regulation: directly applicable and enforceable in all member states as soon as it is passed
Welke 2 Product specific legislation zijn er
General product safety
Product liability
Wat is general product safety van Product specific legislation
Producers may only bring safe products to the market
Information about health and safety risks
Wat is product liability van Product specific legislation
Harm from Defective Products: If a defective product causes harm to a consumer (e.g., injury, property damage), the producer may be held liable.
Definition of Defective: A product is considered “defective” if it does not meet the safety consumers can reasonably expect
When is a product safe
A product which under normal or
reasonably foreseeable conditions of
use, - including, in terms of duration of
use and possibly commissioning,
installation and maintenance requirements, - does not present any
risks, or only limited risks compatible
with its use and, from the point of view of
a high level of protection to the health
and safety of persons, are considered
acceptable
When is a product unsafe
When foreseeable use by a user and
in certain (use) circumstances
injury or other health damage to
humans or animals may occur
Health damage need not have actually occurred yet
When can a health injury be accepted
Risk of accidental injury is acceptable, if accompanied by warnings against careless use and instructions (precautions) in case
things do go unexpectedly wrong
AND considering that the user is generally familiar with the risks of careless use of this type of products
Wlke regulatory bodies of safety voor products zijn er
National road traffic service:
Vehicle type inspection
Health and Youth Inspecotorate: Medicine / medical devices
Inspectorate of Social Affairs and
Employment: Occupational Safety
Inspectorate of environment and transport:
Professional products
Dutch Food and Consumer Product Safety Authority: Consumer products
Telecom agency: telecom products
Hoe worden IVDS verdeeld over de isk classification in MDR
Class A: Low risk containers for
specimen
Class B: Medium risk pregnancy test,
cholesterol self-test
Class C: Moderate to high risk blood
glucose self-test
Class D: High risk Hepatitis B blood donor test, HIV diagnostic blood test
Wat is de risk classification in MDR
Class 1: Low risk adhesive bandages,
wheelchairs, glasses
Class 2a: Moderate risk dental fillings,
surgical clamps
Class 2b: Moderate to high risk anaesthesia machines
Class 3: High risk (direct contact with
heart, central nervous system or circulatory system) cardiac catheters, contraceptive coils
Uit welke stappen betsaat clinical tetsing of high risk medical devices
Pre clinical testing
Clinical investigation
Conformity assessment
Market access
Post market surveillance
Wat is clinical evaluation
Verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer
Wat is een clinical investigation en wanneer is het nodig
Clinical investigations involve additional clinical trials with patients
* Can be necessary when for instance alterations are made, there are
serious direct risks or when invasiveness and duration of use (or reapplications) are involved with the device
Class 2b and 3
Wat is CE marking
Every medical device on the EU market needs a CE marking
* CE mark is a proof of safety, balanced prior assessment of benefits
and potential risks, but also that product complies with legal requirements
* For class 1 devices, this is done by the manufacturer
* All other classes, notified bodies need to be involved
Wat zijn notified bodies
Perform conformity assessment: are procedures in line with
applicable national legislation
When everything is good CE marking
