Legal and Ethical Issues Flashcards
What are two difference directives?
Active implantable medical device directive = powered implants
Medical device directive = medial/ dental materials
What directive are dental implants covered under?
Medical device directive
What is a medical device?
Any instrument, appliance or material intender by manufactured to be used on human being for purpose of diagnosis, prevention, monitoring, tx or alleviating disease
What is CE mark?
Mark appears on any device or its packing meaning device satisfies European legal requirements for it to be fit for its intender purposes
What does CE mark indicate?
Indicate government product can be legally sold in European Union (EU) and European Free Trade Area (EFTA)
How can CE makes products move?
Freely throughout European single market
Why is CE mark good for customers?
Ensure product meet designates minimum safety standards and hence minimum level of quality
Adv of CE mark?
Promotes public health and safety
How are CE marks awarded?
Via competent authority - each member state has a ‘competent authority’ who ensures compliance and evaluates adverse indicates
Who is competent authority of CE mark in UK?
Secretary of State for health - acts via healthcare product regulatory agency
How is compliance checked?
Notified body checks
Competent body authorities independent agencies who check and prove devices meet essential requirements
Does risk change awarding CE MARK?
Class I = low, manufacture declare conformity
Class IIa = medium - manufacture declare and notified body confirm
Class IIb = medium - notified body carries out audit/testing
Class III = high = need submission of a design dossier to notified body
What is safe?
Assessment of biological safety, hazard and risk analysis
What is hazard?
Potential source of harm, harm is any physical injury or damage to health
What is a form of risk management?
imposition of legal controls
