NEW MDR 200 EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED 2026-2027 LATEST UPDATE!!
What is the goal of the MDR? - ANSWER To detect and correct problems in a
timely manner (adverse events and specific malfunctions).
Basic requirements of the MDR? - ANSWER 1. Submit MDR reportable events
2. Develop, maintain, and implement written procedures.
3. Establish and maintain fills for all complaints concerning medical devices.
What are MDR reportable events? - ANSWER Events where death or serious
injury has arised as a possible result or a malfunction occurs that may cause a
serious injury.
MDRs are only meant for - ANSWER medical device manufacturers.
Not for facilities, importers, or distributors.
Required to reports events of: - ANSWER death, serious injury, or device
malfunction.
Malfunctions must be reported if they could - ANSWER cause or contribute to
potential death or serious injury.
MDR reports are to be filed within 30 days after the - ANSWER day you become
aware of the event.
That is why they are filed as 30-day or initial reports.
Who is considered a manufacturer: - ANSWER Any person who manufactures,
prepares, propogates, compounds, assembles, or processes a device by
chemical, physical, biological, or other procedure.
The term includes:
- Repackages or otherwise changes the container, wrapper, or labeling of a
device in the futherance of the distribution of the device from the original place of
manufacture.
- Initiates specifications for devices manufactured by a second party for
subsequent distribution by the person initiating specifications.
- Manufactures components or accessories that are medical devices and that are
ready to be used and are intended to be commercially distributed and intended to
be used as is, or processed by a licensed practitioner or other qualified person to
meet the needs of a particular patient.
, Any person who reprocesses a single use device for reuse in human beings
becomes the manufacturer of the device and... - ANSWER is subject to all the
requirements applicable to the original manufacturer, including the requirements
of MDR regulation.
When have you become aware of an event (as a manufacturer)? - ANSWER Any
employees become aware of an event that reasonably suggests that an event is
required.
Any people in management, quality, seniors, etc. come to find knowledge
requiring an MDR.
The QS regulation requires you to have a formally designated unit for - ANSWER
receiving, reviewing, and evaluating complaints.
Instructions for completing Form 3500A: - ANSWER
http://www.fda.gov/download/safety/medwatch/howtoreport/downloadforms/ucm3
87002.pdf
Information on the current Event Problem Code Hierarchy: - ANSWER
http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequ
irements/reportingadverseevents/eventproblemcodes/ucm134751.htm
Instructions for electronic reporting: - ANSWER electronic Medical Device
Reporting (eDMR) - Home Page
Can I include multiple devices in the same report? - ANSWER A general rule of
thumb is to fill out one MDR per device.
What is the definition of a complaint? - ANSWER Any written, electronic, or oral
communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it is released for
distribution.
You are required to review and evaluate all device-related complaints to
determine whether a complaint represents - ANSWER an MDR reportable event.
Where do complaints come from? - ANSWER Phone calls, verbal transmissions,
fax, written correspondence, email, sales rep reports, customer service reps,
scientific articles, internal analysis, and legal documents.
Employees should be trained to properly identify, collect, and report complaints
to - ANSWER the complaint handling unit.
VERIFIED 2026-2027 LATEST UPDATE!!
What is the goal of the MDR? - ANSWER To detect and correct problems in a
timely manner (adverse events and specific malfunctions).
Basic requirements of the MDR? - ANSWER 1. Submit MDR reportable events
2. Develop, maintain, and implement written procedures.
3. Establish and maintain fills for all complaints concerning medical devices.
What are MDR reportable events? - ANSWER Events where death or serious
injury has arised as a possible result or a malfunction occurs that may cause a
serious injury.
MDRs are only meant for - ANSWER medical device manufacturers.
Not for facilities, importers, or distributors.
Required to reports events of: - ANSWER death, serious injury, or device
malfunction.
Malfunctions must be reported if they could - ANSWER cause or contribute to
potential death or serious injury.
MDR reports are to be filed within 30 days after the - ANSWER day you become
aware of the event.
That is why they are filed as 30-day or initial reports.
Who is considered a manufacturer: - ANSWER Any person who manufactures,
prepares, propogates, compounds, assembles, or processes a device by
chemical, physical, biological, or other procedure.
The term includes:
- Repackages or otherwise changes the container, wrapper, or labeling of a
device in the futherance of the distribution of the device from the original place of
manufacture.
- Initiates specifications for devices manufactured by a second party for
subsequent distribution by the person initiating specifications.
- Manufactures components or accessories that are medical devices and that are
ready to be used and are intended to be commercially distributed and intended to
be used as is, or processed by a licensed practitioner or other qualified person to
meet the needs of a particular patient.
, Any person who reprocesses a single use device for reuse in human beings
becomes the manufacturer of the device and... - ANSWER is subject to all the
requirements applicable to the original manufacturer, including the requirements
of MDR regulation.
When have you become aware of an event (as a manufacturer)? - ANSWER Any
employees become aware of an event that reasonably suggests that an event is
required.
Any people in management, quality, seniors, etc. come to find knowledge
requiring an MDR.
The QS regulation requires you to have a formally designated unit for - ANSWER
receiving, reviewing, and evaluating complaints.
Instructions for completing Form 3500A: - ANSWER
http://www.fda.gov/download/safety/medwatch/howtoreport/downloadforms/ucm3
87002.pdf
Information on the current Event Problem Code Hierarchy: - ANSWER
http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequ
irements/reportingadverseevents/eventproblemcodes/ucm134751.htm
Instructions for electronic reporting: - ANSWER electronic Medical Device
Reporting (eDMR) - Home Page
Can I include multiple devices in the same report? - ANSWER A general rule of
thumb is to fill out one MDR per device.
What is the definition of a complaint? - ANSWER Any written, electronic, or oral
communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it is released for
distribution.
You are required to review and evaluate all device-related complaints to
determine whether a complaint represents - ANSWER an MDR reportable event.
Where do complaints come from? - ANSWER Phone calls, verbal transmissions,
fax, written correspondence, email, sales rep reports, customer service reps,
scientific articles, internal analysis, and legal documents.
Employees should be trained to properly identify, collect, and report complaints
to - ANSWER the complaint handling unit.
