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EU Medical Device Regulation (MDR) PT.2 - Coggle Diagram
EU Medical Device Regulation (MDR) PT.2
declaration of conformity is drawn18 by the manufacturer (dental technician) before the product is placed on the market.
requirements of conformity,
the name and address of the manufacturer
data allowing identification of the device in question
a statement that the device is for the exclusive use of a patient together with the name of the patient
the name of the registered dentist who made out the prescription
the characteristics of the device as specified in the prescription
a statement that the device conforms to the essential requirements and, if applicable,
indicating which essential requirements have not been fully met and the potential risks
the manufacturer must also sign the statement
THE INTERNATIONAL AND NATIONAL LEGISLATIVE FRAMEWORK ON OHS(OCCUPATIONAL AND HEALTH SAFETY)
EUROPE
In the European Social Charter
the Parties agreed on
the following principle:“All workers have the right to safe and healthy working conditions”
The European Directive
89/391 encouraged improvements in the safety and health of
workers
and uniformity of Member States on OHS practices and policies
ITALY
The Italian Constitution
guarantees the protection of health as a fundamental right of the individual and common
interest ” (Art. 32)
protects work in all its forms and applications” (Art. 35)
The Italian Workers’ Statute
The Civil Code
not preventing an event, which one has a legal duty to prevent, is tantamount to causing it”
(Articles 4, 437, 451, 589, 590)
The LD n° 626/94
is the legal milestone on health and safety obligations
in line with the European Commission Framework Directive on safety in the workplaces
The Safety at Work Charter 2000
the main framework document from which the current
Italian regulatory strategy on health and safety has been developed
The LD n. 195/2003
195/2003 introduced significant changes to the Decree n. 626/94 as to professional
requirements of the people in charge for protection and prevention services
LEGISLATIVE DECREE n. 81/2008
The employer has the duty to set up30 a prevention and protection service within the organization
The internal service, or external people, appointed have to:
develop adequate preventive safety measures
provide information on occupational risks, health and safety procedures
identify risk factors and carry out the risk assessment
Parties specifically involved in the risk assessment are:
employers
the head of the prevention and protection service, this can be an internal manager or an
external consultant
a workers’ safety representative for health and safety
and an authorized occupational health doctor
The employer cannot delegate the following activities (Art. 17)
“The Risks Assessment Document” RAD which must have a set date
the designation of the prevention and protection service manager,that is the person responsible for the Protective and Preventive Unit