MCT Beginning

1. The purpose of reviewing the information collected is to determine whether:

• New hazards have occurred
• New hazardous situations have occurred
• The state of the art has evolved
• The risk of a hazardous situation has become unacceptable
• The overall residual risk has become unacceptable
• The overall residual risk has become unacceptable

2. The characteristics of a MD, relating to safety, concern:

• How the MD works
• Inteded use
• Reasonably foreseeable misuse
• Materials in contact with the patient
• User error

3. Following the risk evaluation we can:

• Analyze the risk
• Judge the risk acceptable
• Keep control measures as they are
• Improve existing control measures

4. The evaluation of the overall residual risk takes into account, among other things:

• The sum of individual risks
• The sequence of events
• Special harm
• Risk control measures in conflict with other requirements
• Too many warnings

5. During the design of the medical device, the manufacturer:

• Identifies hazards
• Identifies hazardous situations
• Assesses the risks
• Implements risk control measures
• Collects and analyzes information from production and post-production