Legal and Ethical Issues in Dental Biomaterials Flashcards
Why regulate dental biomaterials?
The need for european standards to assist the free market
The desire to produce medical products that were safe and good for their intended use
EU/EEC legislation only implemented after debate and agreement in european parliament
Identify needs, desires and ideals for a medical device or biomaterial
What is a medical device in Europe? (EC legal definition)
Any instrument, apparatus, appliance, material or other article, used alone or in combination, including a software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:
Diagnosis, prevention, monitoring, treatment or alleviation of disease
…or alleviation of or compensation for an injury or handicap
Investigation, replacement or modification of the anatomy or of a physiological process
Control of conception
What are active implantable medical devices directive?
Covers all powdered implants (e.g. pacemaker)
What are medical devices directive?
Covers most other implants
What does the CE mark indicate?
Indicates to governments that the product can be legally sold within the EU and the eurpean free trade area
Ensures product can move freely throughout the European single market
Indicates to customers that the product meets minimum safety standards and quality
Promotes public health and safety
The result of a risk management exercise
Who awards a CE mark?
The competent authority = secretary of state for health
Classification rules?
Class I - low risk, manufacturer declares conformity
Class IIa - medium risk, manufacturer declares conformity and notified body confirms
Class IIb - medium risk, notified body carries out and audit and/or testing
Class III - high risk, as IIb but require submission of a design dossier to notified body
What is a hazard?
A potential source of harm, where harm is any physical injury and/or damage to health or property
Regulation and management of the risk?
Risk may be the possibility of more than one outcome occurring from a given set of circumstances
Imposition of legal controls is a form of risk management
Biological safety assessment combines aspects of risk analysis, assessment and control
