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FDA/CDRH Webinar

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Medical Device Reporting for 

Manufacturers 

Isaac Chang, Ph.D.

Director, Division of Postmarket Surveillance

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

November 30, 2016 CDRH Webinar
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Medical Device Reporting Regulation

Medical Device Reporting (MDR, 21 CFR Part 803)

• Establishes the reporting requirements for device user facilities, manufacturers 

and importers.

• A mechanism for FDA and manufacturers to identify and monitor significant 

adverse events involving marketed medical devices.

What Types of Events Must Be Reported to FDA?

• If device may have caused or contributed to a death or serious injury. 

• Certain malfunctions must also be reported.

Additional requirements:

• Device manufacturer must conduct a complete investigation of each event (as 

per 21 CFR Part 820.198)

• All information required in 21 CFR Part 803.52

• Develop and implement written MDR Procedures (21 CFR Part 803.17)

• Establish and maintain MDR event files

• Have a system in place that ensures access to infromation that facilitates timely 

follow-up/inspection by FDA.
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“Caused Or Contributed”

• Death or serious injury was or may have been attributed to a medical 

device; 

 or 

• A medical device was or may have been a factor in a death or serious 

injury, including events resulting from: 

* -Failure

* -Malfunction 

* -Improper or inadequate design

* -Manufacturing (problems)

* -Labeling (problems)

* -Use error 
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What Is A Serious Injury?

A reportable serious injury is defined as:

An injury or illness that is:

– Life-threatening

 or 

– Results in permanent impairment or damage to a body function or structure, 

 or 

– Requires medical or surgical intervention to preclude permanent impairment or 

damage to a body function or structure
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When Is a Device Malfunction Reportable?

• The device fails to meet its performance specifications or 

otherwise perform as intended

 and

• The device is likely to cause or contribute to a death or serious 

injury if the malfunction were to recur 
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REPORTER WHAT TO REPORT WHERE WHEN

Manufacturer (Mfr)

(Domestic and 

Foreign)

Deaths, Serious Injuries, Malfunctions FDA Within 30 calendar days of 

becoming aware

Events that require remedial action to 

prevent an unreasonable risk of 

substantial harm

FDA Within 5 working days of 

becoming aware

User Facility

Deaths FDA and Mfr Within 10 working days

Serious Injuries

Mfr 

(FDA if unknown) Within 10 working days

Importer

Deaths and Serious Injuries FDA and Mfr Within 30 calendar days

Malfunctions Mfr Within 30 calendar days

Voluntary Any type of event FDA Any time

21 CFR Part 803: Medical Device Reporting 

Requirements 
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What’s new since the 1997 MDR Guidance 

Document? 

Clarification of several topics

• When a firm “becomes aware” that an MDR reportable event has occurred.

• MDR submission rules involving a marketed device studied under an 

investigational device exemption (IDE).

• MDR submission rules involving adverse events that occur outside the United 

States.

• Exemption request process for MDR reporting for a contract manufacturer

• Clarification of the submission of 5-day reports and remedial actions.

• Clarification on the 2-year presumption for reportable malfunctions.
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“Becoming Aware”

• A firm becomes aware of an event whenever

– Any of your employees become aware of information that reasonably 

suggest that an event is required to be reported in a 30-day report or in a 

5-day report that we have requested from you; or

– Any of your employees with management or supervisory responsibilities 

over persons with regulatory, scientific or technical responsibilities 

(including consultants or contractors) or whose duties relate to the 

collection and reporting of adverse events, becomes aware from any 

information (including any trend analysis) that an MDR reportable 

event(s) necessitates remedial action to prevent an unreasonable risk of 

substantial harm to the public health. 
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MDRs for IDE situations

• If a device is legally marketed in the US and is also under an Investigational 

Device Exemption (IDE), any adverse event that involves the investigational 

use of the marketed device are subject to reporting under both the IDE 

regulation and the MDR regulation. (APPLIES TO NON-INVESTIGATIONAL 

DEVICE) 

• If the device is under study it should be reported under the IDE only. (21 CFR 

Part 812) (APPLIES TO INVESTIGATIONAL DEVICE)

• If a marketed device is used as an investigational device (i.e. under a new 

indication for use), and if the adverse event results from the labeled 

marketed use of the device, it must be reported as an MDR.
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MDR from Outside US (OUS)

• If a foreign adverse event occurs, this chart specifies the MDR reporting 

obligation of the foreign event.

Firm is Market 

Status in US

Market Status 

in OUS country

Report Foreign Event?

US No Yes Yes, when requested.

US Yes Yes Yes

OUS Yes Yes Yes

OUS Under Study Yes Yes (only if a similar device 

marketed in US by the same 

manufacturer)
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Exemption Request for Contract 

Manufacturer 

• Any firm that initiates specifications for devices that are manufactured by a 

second party for subsequent distribution by the person initiating the 

specifications.

• A contract manufacturer who does not distribute or market the devices it 

manufacturers for a specifications developer would not have an MDR 

reporting obligation and would not require an exemption.

• If the contract manufacturer markets the devices that it manufacturers, then 

both the contract manufacturer and the specifications developer have MDR 

reporting obligations. 

• If either the contract manufacturer or specifications developer wants to 

report on behalf of the other, an exemption is needed.
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5-day Reports and Remedial Action

• A “5-day report” is a report that must be submitted to us within five work days after 

the day you become aware of an MDR reportable event:

– That necessitates remedial action to prevent an unreasonable risk of substantial harm to 

public health (remedial action needed); or

– For which we have made a written request for the submission of 5-day reports.

• 5-days begin the day after an employee with management of supervisory 

responsibilities over persons with regulatory, scientific, or technical responsibilities, or 

a person whose duties relate to the collection and reporting of adverse events, 

“becomes aware” of the event. We do not expect employees such as non-technical 

staff to recognize that an adverse event(s) requires remedial action to prevent a risk 

of substantial harm to the public.

• This is NOT the same “become aware” date for normal 30-day reporting. If 6 days 

after a firm becomes aware of an adverse event that is MDR reportable the firm 

determines that it meets the definition of a 5-day report, they have until Day 11 to 

file this 5-day report.
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5-day Reports and Remedial Action

• A “remedial action” is any action, other than routine maintenance or 

servicing of a device, necessary to prevent recurrence of an MDR reportable 

event. FDA does not consider an action taken to correct only a single device 

involved in an MDR reportable event to be a remedial action.

• Not all MDR reportable events requiring remedial actions need to be 

submitted as 5-day reports. Only events that require remedial actions to 

prevent an unreasonable risk of substantial harm to the public health or 

events for which FDA requests such a report must be submitted as 5-day 

reports.

• When the remedial action taken is not required to address an unreasonable 

risk of substantial harm to the public health the reportable adverse events 

should be submitted as 30-day reports instead of 5-day reports.
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2- Year Presumption

• An MDR guidance for manufacturers issued in 1997 stated that once a 

malfunction has caused or contributed to a death or serious injury, a 

presumption that the malfunction is likely to cause or contribute to a death 

or serious injury has been established. 

• This presumption will continue until either the malfunction has caused or 

contributed to no further deaths or serious injuries for two years, or the 

manufacturer can show through valid data that the likelihood of another 

death or serious injury as a result of the malfunction is remote.

• Either:

 Report for 2 year OR

and

Notify FDA with data and

rationale for 

discontinuation

Request an exemption

sooner than 2 years with 

data showing incidence 

rate and evidence that 

malfunction cannot recur.
Questions?

MDR help desk: MDRPolicy@fda.hhs.gov

Phone (unattended, voice mail only): 301-796-6670

Slide Presentation, Transcript and Webinar Recording 

will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Post-Market Activities; Sub-heading: 

Medical Device Reporting (MDR)