Contents
I.
Implantable medical device ................................................................... 1
II. Label ...................................................................................................... 1
III. Instruction for use ................................................................................. 2
IV. Clinical Investigation ............................................................................. 3
V. Clinical evaluation .................................................................................. 4
VI. Informed consent.................................................................................. 5
VII. Economic operators .............................................................................. 6
VIII. Active medical device ........................................................................... 7
IX. Serious incident ..................................................................................... 7
X. Post market surveillance ........................................................................ 8
XI. References ............................................................................................ 9
I.
Implantable medical device
 Definition:
An implantable medical device is an implantable biomedical
device placed in the human body during surgery or other clinical
intervention to serve a specific function.
 Examples:
They include artificial joints, breast implants, contraceptive IntraUterine Devices (IUDs), and bone, muscle, and joint fusion
hardware.
II.
Label
 Definition:
Any written, printed, or graphic information appearing either on
the device itself, or on the packaging of each unit or on the
packaging of multiple devices
 Example:
1
In figure 1, the label contains the following information:

Red box: Unique device identifier (UDI)

Green box: Manufacturer’s name & address

Yellow box: Symbols of medical device labels (from left to
right of boxsingle use, do not use if package is damaged,
Figure 1: An example of a label of a fictitious implantable medical
device to familiarize with how a label generally looks like
temperature limit, & keep dry)
III.

Blue box: ‘Use by’ date is set as an exact number of years
from the date of manufacture

Purple box: Lot/batch number

Orange box: CE mark
Instruction for use
 Definition:
The information provided by the manufacturer to inform the user
of a device's intended purpose and proper use and of any
precautions to be taken
2
 Examples:
Figure2: Instructions for use of sterile
implants
In
accordance with
the MDR, instructions for use for medical devices must contain
certain key information. Figure 2 (source of image is provided in
references section) includes:
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IV.
General instructions that include intended purpose
Device description
Indications & contra-indications
Warnings
Precautions
Possible adverse effects
Packaging & sterilization of sterile implants
MRI safety information
Implant usage
Limited warranty
Contact information
Label symbol legend
Clinical Investigation
 Definition:
Segment of clinical research for which an investigator directly
interacts with patients in either an outpatient or inpatient
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setting. Any systematic investigation or study in or on one or
more human subjects, undertaken to assess the safety, clinical
performance and/or effectiveness of a medical device
 Examples:
Any clinical investigation must: · be based on the results of the
clinical evaluation process, · follow a proper risk management
procedure to avoid undue risks, · be compliant with all relevant
legal and regulatory requirements, · be appropriately planned,
conducted, analysed and reported, · follow appropriate ethical
principles
V.
Clinical evaluation
 Definition:
A set of ongoing activities that use scientifically sound methods
for the assessment and analysis of clinical data to verify the
safety, clinical
 Examples:
It involves a report that ensures the device is safe & performs per
requirements. The report includes the details of the clinical
background, current knowledge, state of art which can be used
to evaluate the safety and performance of the device for
corresponding to its intended purpose, adequacy of the
information materials supplied, whether the intended purpose
and risk reduction measures are adequate, any discrepancies,
and conclusions of the clinical evaluation performed on the
medical device based on all relevant clinical data available.
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VI.
Informed consent
 Definition:
Informed Consent is the decision, which must be written, dated
and signed, to take part in a clinical trial, taken freely after being
duly informed of its nature, significance, implications and risks
and appropriately documented, by any person capable of giving
consent or, where the person is not capable of giving consent, by
his or her legal representative; if the person concerned is unable
to write, oral consent in the presence of at least one witness may
be given in exceptional cases, as provided for in national
legislation
 Examples:
An informed consent form is required in the following cases:
When the research involves:
 Patients
 Children
 Incompetent/Incapacitated persons
 Healthy volunteers
 Immigrants
 Others (i.e.prisoners)
When the research uses/collects:
 Human Genetic Material
 Biological samples
 Personal data
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Figure 3: Informed consent form of a clinical trial. The
form of medical device would be similar to this
example
VII. Economic operators
 Definition:
Economic operators are defined as either “a manufacturer, an
authorized representative, an importer, or a distributor” of
medical devices.
 Examples how economic operators interact under EU MDR:
 When the manufacturer is located in the EU
For this example, let’s say the legal manufacturer is located in
France, an EU member state. Their product is made in China
and it enters the port at Rotterdam in the Netherlands. The
manufacturer also has distributors in Spain and Switzerland.
Let’s also say that the legal manufacturer is maintaining
financial ownership of the product as it enters the EU. In this
case, they do not need an importer as defined by MDR. They
may need an importer as regards customs regulations, but
that is not the same thing as an importer under MDR.
Additionally, because the legal manufacturer is located in an
EU member state, they won’t need an authorized
representative.
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So, with this example, we only have three economic
operators: the legal manufacturer and the two distributors.
 When the manufacturer is located outside of the EU
Let’s look at an example where the manufacturer is based in
the US, and the devices are still made in China and come
through the port at Rotterdam. The distribution centers are
still in Spain and Switzerland, but the manufacturer has an
affiliate in Belgium that has financial ownership of the devices
when they come into the EU.
In this case, the manufacturer will need an authorized
representative, as the company is located outside of the EU.
They still have the two distributors in Spain and Poland, but
now have an importer (the affiliate in Belgium), as well. There
are a total of five economic operators in this instance.
VIII. Active medical device
 Definition:
A medical device relying for its functioning on a source of
electrical energy or any source of power other than that directly
generated by the human body or gravity.
 Examples:
Include ablation devices, body-worn sensors, hearing aids, heartlung machines, infusion pumps, patient monitors, ventilators,
radiation therapy, software devices, surgical lasers, surgical
robots, ultrasound devices, and X-ray machines.
IX.
Serious incident
 Definition:
Any incident that directly or indirectly led, might have led or
might lead to any of the following; the death of a patient, user or
other person, the temporary or permanent serious deterioration
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of a patient's, user's or other person's state of health, a serious
public health threat.
 Manufacturers of devices, which caused serious incident,
shall report to the relevant competent authorities
 Examples:
 The CCE vice president, Mark Bruley, was asked to perform
a competency review of a hospital’s biomed department
due to a fatal accident involving a child who had been
connected to a perfusion pump. Specifically, the perfusion
pump had a broken guard over a switch, which caused the
pump to stop
working. In addition,
the investigation
revealed that some
of the heart/lung
consoles in service
had corrosion on the
electrical connectors.
 Bruley cites a case in
which a pediatric
patient received a
burn in the mouth
during a
tonsillectomy. The
Figure 4: Serious incident template
procedure involved
two separate devices: a
suction coagulator and the electrosurgical unit (a piece of
capital equipment). The risk manager filed the report,
claiming a problem with the electrosurgical unit, but did
not obtain the biomed’s assessment of the situation. If the
risk manager had communicated with the biomed, he
would have learned that the problem occurred with the
suction coagulator, not the capital equipment.
X.
Post market surveillance
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 Definition:
The MDR defines post-market surveillance as a proactive and
systematic process which manufacturers implement and carry
out (with other economic operators) in order to take corrective
and preventive action (CAPA) in accordance with information on
medical devices and their performance.
 MDR Requirements:
Every manufacturer is required to plan, establish, document,
implement, maintain and update a PMS system for every medical
device.
A well-written PMS Plan will account for using data from a wide
range of different sources including:
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Serious incidents
Field Safety Corrective Actions (FSCAs)
Complaints
Databases and/or registries
Feedback and complaints
A well-designed PMS system will monitor the safety and
performance of a medical device through two complementary
domains:
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XI.
Post-Market Clinical Follow-up (PMCF) that involves the
design and conduct of clinical studies to proactively and
continually assess device safety and performance
Vigilance systems that monitor and respond to complaints,
adverse events, media reports, serious incidents and
FSCAs
References
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https://www.bsigroup.com/en-IL/medical-devices/technologies/activemedical-devices/
https://sterlingmedicaldevices.com/thought-leadership/medical-devicedesign-industry-blog/what-are-implantable-medical-devices/
https://advisera.com/13485academy/blog/2020/09/20/how-to-createmedical-device-labels-compliant-with-
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mdr/#:~:text=According%20to%20the%20definitions%20in,the%20packagin
g%20of%20multiple%20devices.
https://mdrregulator.com/news/how-to-properly-label-a-medical-devicemdr-2017-745
https://www.reuschlaw.de/en/news/mdr-requirements-for-instructions-foruse-for-medicaldevices/#:~:text=In%20accordance%20with%20the%20Medical,any%20prec
autions%20to%20be%20taken.
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrftech-191010-mdce-n57.pdf
https://www.ncbi.nlm.nih.gov/books/NBK222768/
https://www.i3cglobal.com/clinical-evaluation-report-sample/
https://ec.europa.eu/research/participants/data/ref/fp7/89807/informedconsent_en.pdf
https://www.unitedlanguagegroup.com/blog/strategy/new-roles-economicoperatorsmdr#:~:text=According%20to%20Article%202%20of,a%20distributor%E2%8
0%9D%20of%20medical%20devices.
https://www.greenlight.guru/blog/economic-operators
https://www.acf.com.tr/mdr-chapter-7vigilance/#:~:text='Serious%20Incident'%20means%20any%20incident,a%20
serious%20public%20health%20threat.
https://decomplix.com/post-market-surveillancepms/#:~:text=The%20MDR%20(Art%202%20(60,medical%20devices%20and
%20their%20performance.
https://www.restor3d.com/pdf/IFU1_Sterile-Implants.pdf
https://24x7mag.com/standards/regulations/medical-device-incidents/
https://www.acf.com.tr/mdr-chapter-7vigilance/#:~:text='Serious%20Incident'%20means%20any%20incident,a%20
serious%20public%20health%20threat.
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