THE ESSENTIAL REQUIREMENTS

• General Requirements
• Design and Construction requirements
• Chemical, physical and biological properties
• Infection and microbial contamination
• Construction and environmental properties
• Information supplied by the manufacturer on the label and in the instructions for use

TECHNICAL FILE

Technical file contains all the relevant information that is needed to demonstrate the essential health and safety requirements of the directive such as

• Product design
• Product Inspection requirements
• EC declaration of Conformity
• Risk analysis
• Clinical study etc.

RISK ASSESSMENT

1. One of the essential requirements of the directive – Manufacturer to Conduct
2. Medical Device-Risk analysis standard-EN 1441 : 1998

• Identify qualitative and quantitative characteristics related to medical device
• Identify possible hazards
• Estimate the risk for each hazard for both normal conditions and use in case of failure
• Determine whether the risk is acceptable
• Determine whether the risk can be reduced
• If a risk is reduced , determine if other hazards have been generated
• Evaluate all identified hazards
• Determine if the device safety is adequate
• Review risk analysis

VIGILANCE SYSTEM

1. The purpose of the system is to reduce the likely-hood of repeatation of the same type of adverse incident
2. It is a guide line for notification of adverse incident. The guideline covers activities of

• The commission
• Competent authorities
• Notified bodies
• Manufacturer
• Users and others concerned with the continuing safety of medical devices

VIGILANCE SYSTEM

• Manufacturer must establish and update a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions.
• Incidents to be reported by manufacturers/ authorized representatives and users to competent authorities
• Time scale for the initial reporting of an incident (10 days) or near incident (30 days) are to be adhered to

INCIDENTS TO BE REPORTED

• Incidents involving malfunction in the characteristics and performance of a device, as well as any accuracies in the instruction leaflets which might lead to, or might have lead to, the death of a patient or to serious deterioration in his/her health.
• If a manufacturer systematically recalls a device for technical or medical reasons or issues advisory notice

EC DECLARATION OF CONFORMITY

• Product identification
• Identification of the manufacturer
• Directives complied with
• Standards used
• Signature by authorized person
• Language requirements