Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
32
Medical Device Reporting
21 CFR 80321
The Medical Device Reporting (MDR)
Regulations are enacted in 21 CFR 803, which
defines the requirements for postmarket adverse
event reporting and malfunctions or other safety
concerns applicable to the marketed device by
device manufacturers, user facilities, importers,
and distributors. The statutory authority for the
medical device reporting regulation is Section
519(a)22 of the FD&C Act. It establishes the reg-
ulatory pathway for collecting reportable adverse
event data and defines critical reporting roles,
responsibilities, and timelines. On 11 December
1995, the MDR regulations for user facilities
were published in the Federal Register, and on
31 July 1996, the new MDR regulations became
effective for medical device manufacturers and
user facilities. The Food and Drug Administration
Modernization Act (FDAMA) of 1997 amend-
ment to the medical device adverse event (AE)
reporting requirement became effective on 11
February 1998. On 26 January 2000, changes to
medical device reporting regulations, 21 CFR
803, were published in the Federal Register to
reflect the changes in the Act.
Responsible parties are defined by FDA
under 21 CFR 803.3 as follows:23
• “Device user facility” means a hospital,
ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient
treatment facility as defined in this section,
which is not a physician's office, as defined
in this section. School nurse offices and
employee health units are not device user
facilities.
• “Distributor” means any person (other than
the manufacturer or importer) who furthers
the marketing of a device from the original
place of manufacture to the person who makes
final delivery or sale to the ultimate user, but
who does not repackage or otherwise change
the container, wrapper, or labeling of the
device or device package. If a person repack-
ages or otherwise changes the container,
wrapper, or labeling, they are considered a
manufacturer, as defined in this CFR.
• “Importer” means any person who imports
a device into the US and who furthers the
marketing of a device from the original place
of manufacture to the person who makes
final delivery or sale to the ultimate user, but
who does not repackage or otherwise change
the container, wrapper, or labeling of the
device or device package. If a person repack-
ages or otherwise changes the container,
wrapper, or labeling, they are considered a
manufacturer as defined in this section.
• “Manufacturer” means any person who
manufactures, prepares, propagates,
compounds, assembles, or processes a device
by chemical, physical, biological, or other
procedure. The term includes any person
who either:
º Repackages or otherwise changes the
container, wrapper, or labeling of a
device in furtherance of the distribution
of the device from the original place of
manufacture
º Initiates specifications for devices that
are manufactured by a second party for
subsequent distribution by the person
initiating the specifications
º Manufactures components or acces-
sories that are devices that are ready
to be used and are intended to be
commercially distributed and intended
to be used as is, or are processed by a
licensed practitioner or other qualified
person to meet the needs of a particular
patient or is the US agent of a foreign
manufacturer
• Initial distributors of foreign entities where
“distributor” means any person other than
manufacturer or importer who is responsible
for the marketing of a device from the orig-
inal place of manufacture to the person who
makes final delivery to the final user but is
not involved in the repackaging or changing
the container, wrapper, or labeling of the
device or device package.
The following are a few additional definitions
associated with MDR requirements, as described
in 21 CFR 803.3:23
Chapter 2: Postmarket Compliance: US
32
Medical Device Reporting
21 CFR 80321
The Medical Device Reporting (MDR)
Regulations are enacted in 21 CFR 803, which
defines the requirements for postmarket adverse
event reporting and malfunctions or other safety
concerns applicable to the marketed device by
device manufacturers, user facilities, importers,
and distributors. The statutory authority for the
medical device reporting regulation is Section
519(a)22 of the FD&C Act. It establishes the reg-
ulatory pathway for collecting reportable adverse
event data and defines critical reporting roles,
responsibilities, and timelines. On 11 December
1995, the MDR regulations for user facilities
were published in the Federal Register, and on
31 July 1996, the new MDR regulations became
effective for medical device manufacturers and
user facilities. The Food and Drug Administration
Modernization Act (FDAMA) of 1997 amend-
ment to the medical device adverse event (AE)
reporting requirement became effective on 11
February 1998. On 26 January 2000, changes to
medical device reporting regulations, 21 CFR
803, were published in the Federal Register to
reflect the changes in the Act.
Responsible parties are defined by FDA
under 21 CFR 803.3 as follows:23
• “Device user facility” means a hospital,
ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient
treatment facility as defined in this section,
which is not a physician's office, as defined
in this section. School nurse offices and
employee health units are not device user
facilities.
• “Distributor” means any person (other than
the manufacturer or importer) who furthers
the marketing of a device from the original
place of manufacture to the person who makes
final delivery or sale to the ultimate user, but
who does not repackage or otherwise change
the container, wrapper, or labeling of the
device or device package. If a person repack-
ages or otherwise changes the container,
wrapper, or labeling, they are considered a
manufacturer, as defined in this CFR.
• “Importer” means any person who imports
a device into the US and who furthers the
marketing of a device from the original place
of manufacture to the person who makes
final delivery or sale to the ultimate user, but
who does not repackage or otherwise change
the container, wrapper, or labeling of the
device or device package. If a person repack-
ages or otherwise changes the container,
wrapper, or labeling, they are considered a
manufacturer as defined in this section.
• “Manufacturer” means any person who
manufactures, prepares, propagates,
compounds, assembles, or processes a device
by chemical, physical, biological, or other
procedure. The term includes any person
who either:
º Repackages or otherwise changes the
container, wrapper, or labeling of a
device in furtherance of the distribution
of the device from the original place of
manufacture
º Initiates specifications for devices that
are manufactured by a second party for
subsequent distribution by the person
initiating the specifications
º Manufactures components or acces-
sories that are devices that are ready
to be used and are intended to be
commercially distributed and intended
to be used as is, or are processed by a
licensed practitioner or other qualified
person to meet the needs of a particular
patient or is the US agent of a foreign
manufacturer
• Initial distributors of foreign entities where
“distributor” means any person other than
manufacturer or importer who is responsible
for the marketing of a device from the orig-
inal place of manufacture to the person who
makes final delivery to the final user but is
not involved in the repackaging or changing
the container, wrapper, or labeling of the
device or device package.
The following are a few additional definitions
associated with MDR requirements, as described
in 21 CFR 803.3:23