Medical Device Compliance: Postmarket Requirements (Ch. 14) Flashcards
What is the definition of a postmarket surveillance system?
A systematic postproduction phase device experience procedure, and the appropriate means to apply any necessary corrective actions
What is the Medical Device Vigilance System?
The criteria and procedures used by manufacturers, CA’s, and all other interested parties to notify and handle incidents and FSCAs
What is the intent of the General Product Safety Directive (GPSD) 2001/95/EC?
Intended to ensure a high level of consumer product safety, and it completes, compliments, and reinforces the medical device vigilance provisions
TRUE/FALSE: A post-market surveillance system is both proactive and reactive.
True
Who is responsible for defining risk-acceptance criteria to demonstrate compliance with relevant standards?
The manufacturer
TRUE/FALSE: Risk management is an activity that should be carried out during the design phase of the device lifecycle.
FALSE! The risk management file is a living document in all phases of the medical device’s lifecycle: design, production, or postmarket surveillance
What is a PMS Plan?
PMS Plan: defines the postmarket activities to be conducted for a product or group of products
What is a PMCF?
PMCF: Post-Market Clinical Follow-Up
Investigates and assesses residual risks in the postmarket phase
What are reasons to conduct a PMCF study?
- Increased risks
- Limited premarket data
- Newly identified risks
- CE-marking based on equivalence
Who is responsible for establishing and operating a medical device vigilance system within each Member State?
Competent Authorities
What is the EUDAMED database?
EUDAMED: European Databank on Medical Devices
- A central database for information exchange among CAs and the Commission
What is MEDDEV 2.12/1 rev 8?
MEDDEV 2.12/1 rev 8
Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System
What are the types of incidents to be reported?
- Incidents resulting in a death of a patient, user, or other person
- Incidents resulting in a serious deterioration in a patient, user, or other person’s state of health
- Events that might have led to death or serious deterioration in health but did not, as a result of fortunate circumstances or the intervention of healthcare personnel
What are the criteria for incident reporting?
- An event has occurred
- The manufacturer’s device is suspected of being a contributory cause of the incident
- The event led, or might have led, to one of the following outcomes:
a. Death of a patient, user, or other person
b. Serious deterioration in the state of health of a patient, user, or other person
What is the definition of a malfunction or deterioration?
The device’s failure to perform its intended purpose when used in accordance with the manufacturers instructions
What are the timelines for initial incident reporting?
2 days: serious public health threat
10 days: death or unanticipated serious deterioration
15 days: other serious incidents
Where is a vigilance report submitted?
To the CA in the country in which the incident occurred
What is trend reporting?
required to report a significant increase or trend in events or incidents usually excluded from individual reporting
What is the Safeguard Clause?
Gives Member States the right to take all appropriate interim measures to withdraw a device from the market
- Outcome: Other Member States are informed, and may adopt appropriate national measures
What is the Health Monitoring Measure?
Allows a Member State to take any necessary and justified actions to protect consumer health and safety or the public health
- Outcome: If the Commission agrees, it develops a measure that must be adopted uniformly throughout the Community
What components will be included in the new and improved EUDAMED?
- Devices & UDI Info
- Certificates
- Clinical Investigations
- SRN - EO info
- NB accreditation and designation
- Applications for conformity assessment by NB
- Summaries of safety and clinical performance
- Performance studies for IVDs
- Market surveillance
