MDR Readiness

Checklist

Prepared by
Cite Medical Solutions

Phone: +1 (888) 765-3080

Email: info@citemedical.com
Website: www.citemedical.com
MDR Readiness Checklist

Table of Contents
Whitepaper

How to prioritize your actions for MDR readiness? 003

TIP 1:  Take a Breath 004

TIP 2:  Simplify your QMS to speed your remediation projects 004

TIP 3: Be aligned with the current medical product standard

and increase your internal testing capabilities 005

TIP 4: Use operational checklists for each GSPR Flash Audit

(a flash audit for each CE-marked device) 006

TIP 5:  Build your MDR Action Plan with our proven check-list 007

Flash Audit Between Regulation (UE) 2017/745

and Directive 93/42/EEC 009

002
 MDR Readiness Checklist

How to prioritize your actions

for MDR readiness?

How to succeed in a timely and

a cost effective manner?

The Checklist tool generally helps us to effectively plan our workload. But the new Medical
Device Regulation (2017/745) is a mass of new requirements. And the checklist can
become a nightmare or much too superficial og a tool.

This article offers a hand-on approach based on practical consulting experiences.

The ultimate goal is to be regulatory compliant and at the same time, to maintain or gain
competitive advantages in the moving medtech industry.

003
MDR Readiness Checklist

Tip 1:
Take a Breath
MDR has been delayed and becomes less dogmatic than initially. Impacts will be easily
manageable for class I medical devices (2024). Clinical Evaluation can take advantage
of the clinical digitalization. And the establishment of a closer relation with your key
distributors will probably open more business opportunities as a secondary benefit.

Tip 2:
Simplify your QMS to speed
your remediation projects
It is one of the critical points of the new MDR, full compliance with ISO 13485 becomes
mandatory. Our advice is to initially perform a short internal review of your current QMS
KPI. It is time to go straight to essential. A sharp QMS will help you to identify the key risks
of your medical devices. Have these risks been currently and correctly mitigated for the
new MDR?

Please note than now the clinical assessment is a continuing effort during both the
design process and the post-market surveillance. Maybe it is time to refine your company
organization to have a smooth clinical-driven medical device Lifecycle.

004
 MDR Readiness Checklist

Tip 3:
Be aligned with the current
medical product standard
and increase your internal
testing capabilities
(MDR asks for the state of Art standards =
the last version)
Standardization sometimes offers technical recommendations which can help a lot to
understand the regulatory requirements. The second advice is to try, fail and learn about
the product test protocols. One common misunderstanding of the standardization is tests
cost a lot and you need to pay a third party lab. It is partially true, most of the standardized
tests are basic to implement with low-cost test benches and you can internalize more
tests than you can imagine.

Biocompatibility shall be now rigorously proven at each product lifestage (clinical, design,
production, refurbishment), a long-term approach of your tests strategy is helpful.

Mastering the product tests during the design and the production, is not just a regulatory
investment, it is the key for your company performance.

005
MDR Readiness Checklist

Tip 4:
Use operational product
checklists
First Use a checklist for product compliance. Edit one checklist by product. Do not
be afraid if initially it seems to be a huge effort. But in fact, your checklist can be an
operational version of the new General Safety and Performance Requirements checklist.
In other words the spine of each medical device technical file. The GSPR table is the
new format for the Essential Requirements table: the corresponding workload to convert
all your current Essential Requirements (Annex I, 93/42/EEC ) is huge and can become
painful. It is the hard point of the MDR transition, and we advise to do -with the highest
priority - this work because:

• GSPR tables shall be signed and effective for the class 1 CE-marked devices (class 1
devices remaining class 1 devices) under MDR 2017/745
• ER tables shall be duly updated with Post-Market Surveillance for class 1 devices, with
a classification change under MDR 2017/745 (class 1r, 1s or Class IIa)
• Analysis based on the GSPR tables shall be prepared for class IIa (eventually class IIb)
devices, where a design change is planned in the short-term.
• The GSPR tables shall be duly prepared for class IIb or class III devices, where MDR
2017/745 have a deep impact on the core regulatory-compliance evidences

Use a three column check-list:

• A column for the MDD essential requirements

• A column for the MDR GSPR (with new requirements in red, change in orange, same
content in green)
• A column with the technical interpretation for your company (general level and a
product-focus level). Most of the parts will be N/A. You will be able to remove the N/A
part outside your QMS scope.

Please find here the attached free GSPR checklist - The initial GSPR Assessment can
be done through a Flash Audit. This method offers you to emphasize the key deficiencies
and findings between the old and the new regulations, on a product compliance analysis-
basis.

Please Note than the GSPR gap analysis is the most profitable work in which you can
engage because the GSPR table is the spine of each CE-marked technical File

006
 MDR Readiness Checklist

Tip 5:
Go straight to a sharp
action plan
Use a second checklist for company compliance:

• Align your quality plan so you can define MDR CAPA with priority rules as major
corrective action / minor CAs with opportunities for improvement,
• Ensure your quality management system is up-to-date
• Verify that the Person Responsible for Regulatory Compliance (PRRC) is aligned with
his new regulatory responsibilities
• Identify the reclassification need and the corresponding technical gap for each
reclassified device (based on the GSPR table.)
• Ask for quotations to the respective Notified Body for each reclassified device
• Prepare test protocols with 3rd Party Labs and ask for quotations
• Update your regulatory planning protocols
• Ensure Post-Market Surveillance is in place with MDR requirements or MDD
requirements (Class 1 MDD device with 27 May 2024 extension)
• Ensure Post-Market Clinical Follow-up is enough robust to support data privacy
requirements (GPDR directive) and to smoothly prepare an MDR transition
• Update your company audit plan, especially with your distributors audits and the audit
of your critical suppliers.
• Write your own checklist specification here: .
Keep it mind your know-how is unique. Your specificities are your battle forces!

007
MDR Readiness Checklist

Use Literature
Search As Your MDR
Foundation

Literature searches are by far the only, most comprehensive way to

review the state of any product and it’s safety record in the market. By
analyzing all published, relevant research (that have occurred since the
previous filing) a manufacturer can satisfy its due diligence to manage
the products continued safe and effective use. Over time this yields a
robust process that will identify any potential indicators that may impact
user saftey/efficacy and respond accordingly.

The issue as it stands today is that a proper “Literature Search”, outside

of the CiteMed model is labor intensive, staff and cost prohibitive,
and restricted by the number of products that can be managed
simultaneously. Quite often these activities cannot achieve established
timelines and overwhelm the hardworking, dedicated teams responsible
for generating these reports (repeatedly) for large numbers of products.

This is why we recommend exploring exactly how using CiteMed

technology can not only guarantee uniformity and consistency of
these searches and reports, but can help clients achieve regulatory
compliance for all its products in a timeframe that keeps them
competitive in the world market.

Ethan Drower
Ethan Drower, Managing Partner
Cite Medical Solutions

008
 Doc Number Rev
Flash Audit between the General Safety and Performance
Requirements of Regulation (UE) 2017/745
and the Essential Requirements of Directive 93/42/EEC TOL-XX 00

Device or device family concerned: ….............................................…………………………………………………………

Device:  Software as Medical Device  Hardware Medical Device  Implantable Medical Device  OTHER

Responsibility:  OEM Project  Custom Project:

Product Manager: Project Manager:

DISCLAIMER This document only constitutes a proposal for a comparative table ;Please refer to 2017/745
GSPR list for in depth analysis

How to read the table:

Colour Meaning

Green Identical requirement

Orange Different

Red Specific requirement of the Regulation,

 PART 1: Flash Audit Checklist
Chapter I - GENERAL REQUIREMENTS

GSPR (MDR) ER (MDD) OK KO Action

Plan
1. Safety 1.(1) Design & Manufacture: risk
base approach
    1.(2) design controls - safety
driven design
    1.(3) medical intended use
2. reduce risks as far as possible 2.(1) eliminate risks
    2.(2) Alarms
    2.(3) benifits/ratio for risk
mitigation
       
3. risk management    
3.a a) r isk management plan for    
each device
3.b b) identify and analyse the    
known and foreseeable
hazards associated with
each device;
3.c c) e stimate and evaluate    
the risks associated with,
and occurring during, the
intended use and during
reasonably foreseeable
misuse
3.d d) e liminate or control the    
risks referred to in point
(c) in accordance with the
requirements of Section 4
3.e e) information from the    
production phase and, in
particular, from the post-
market surveillance system,
3.f f) b
 ased on the evaluation of    
the impact of the information
referred to in point (e), if
necessary amend control
measures in line with the
requirements of Section 4
4. Risk Mitigation
4. a) eliminate or reduce risks as
far as possible through safe
design and manufacture
4. b) w
 here appropriate, take  
adequate protection
measures, including alarms
if necessary, in relation
to risks that cannot be
eliminated; and
4. c) p
 rovide information  
for safety (warnings/
precautions/contra-
indications) and, where
appropriate, training to users
4. Manufacturers shall inform  
users of any residual risks
5. In eliminating or reducing  
risks related to use error, the
manufacturer shall:
5. a) r educe as far as possible  
the risks related to the
ergonomic features of the
device and the environment
in which the device is
intended to be used (design
for patient safety), and
5. [usability] technical knowledge,  
experience, education, training
and use environment, where
applicable, and the medical
and physical conditions of
intended users (design for lay,
professional, disabled or other
users).
6. the lifetime of the device
7. adverse event affected during
transport and storage
4. The solutions adopted by
the manufacturer for the
design and construction of
the devices must conform
to safety principles, taking
account of the generally
acknowledged state of the
art.
  eliminate or reduce
risks as far as possible
(inherently safe design and
construction),
- where appropriate take
adequate protection
measures including
alarms if necessary, in
relation to risks that
cannot be eliminated
 
d) inform users of the
residual risks due to
any shortcomings of the
protection measures
adopted risk
a) reduce as far as
possible the risks
related to the ergonomic
features of the device
and the environment
in which the device is
intended to be used
(design for patient
safety), and
 
4 the lifetime of the device
5 adverse event affected
during transport and
storage
8. undesirable side-effects,
benefit - risk ratio
   
9. risk annex 16 (non-medical
equipment: aesthetic - sport
well being - beauty
GSPR (MDR)
10. Chemical, physical and
biological properties
10.1 Devices shall be designed and
manufactured in such a way as
10.1 a) t he choice of materials
and substances used,
particularly as regards
toxicity and, where relevant,
flammability;
10.1 b) the compatibility between
the materials and
substances used and
biological tissues, cells
and body fluids, taking
account of the intended
purpose of the device and,
where relevant, absorption,
distribution, metabolism and
excretion;
10.1 c) the compatibility between
the different parts of a
device which consists of
more than one implantable
part
10.1 d) the impact of processes on
material properties;
10.1 e) w
 here appropriate, the
results of biophysical or
modelling research the
validity of which has been
demonstrated beforehand
6 Any undesirable side-
effect must constitute
an acceptable risk when
weighed against the
performances intended
  Demonstration of
conformity with the
essential requirements
must include a clinical
evaluation in accordance
with Annex X
   
ER (MDD) OK KO Action
Plan
   
7.1 Particular attention must
be paid to:
  - the choice of materials
used, particularly as
regards toxicity and,
where appropriate,
flammability
  - the compatibility
between the materials
used and biological
tissues, cells and body
fluids, taking account of
the intended purpose of
the device,
   
   
  - where appropriate, the
results of biophysical
or modelling research
whose validity has
been demonstrated
beforehand.
10.1 f) the mechanical properties
of the materials used,
reflecting, where appropriate,
matters such as strength,
ductility, fracture resistance,
wear resistance and fatigue
resistance
10.1 g) s urface properties; and
10.1 h) the confirmation that the
device meets any defined
chemical and/or physical
specifications.
10.2 minimise the risk posed by
contaminants and residues
to patients, (Device and
packaging)
10.3 materials, substances and
gases with which they enter
into contact during their
normal use or during routine
procedures; products
10.4 Substances (see
comprehensive checklist if
applicable) = Medicine, dody
fluid including gazes
10.4.2 Justification regarding the
presence of CMR and/
or endocrine- disrupting
substances
10.4. 3 Guidelines on other CMR
and endocrine-disrupting
substances
10.4. 4 Labelling other CMR and
endocrine-disrupting
substances
10.5 risks posed by the
unintentional ingress of
substances
   
   
   
7.2 minimise the risk posed by
contaminants and residues
to patients, (Device and
packaging)
7.3 materials, substances
and gases with which
they enter into contact
during their normal use or
during routine procedures;
products
7.5 Substances
7.5 substances which are
carci- nogenic, mutagenic
or toxic to reproduction,
in accordance with Annex
I to Council Directive
67/548/EEC of 27 June
1967
   
  Labelling which are carci-
nogenic, mutagenic or
toxic to reproduction, in
accordance with Annex
I to Council Directive
67/548/EEC of 27 June
1967
  risks posed by the
unintentional ingress of
substances
10.6 risks linked to the size and the    
properties of particles which
are or can be released into
the patient’s or user’s body,
unless they come into contact
with intact skin only. Special
attention shall be given to
nanomaterials.
11. Infection and microbial    
contamination
11.1 risk of infection to patients, 8.1 risk of infection to patients,
  a) r educe as far as possible    
and appropriate the risks
from unintended cuts and
pricks, such as needle stick
injuries,
  b) allow easy and safe handling    
  c) r educe as far as possible    
any microbial leakage from
the device and/or microbial
exposure during use, and
  d) prevent microbial    
contamination of the device
or its content such as
specimens or fluids
11.2 Where necessary devices shall    
be designed to facilitate their
safe cleaning, disinfection,
and/or re-sterilisation
11.3 Devices labelled as having    
a specific microbial state
that remain in that state
during transport and storage
conditions
11.4 sterile state remain sterile 8.3 sterile state remain sterile
during transport and storage during transport and
storage

11.5 Devices labelled as sterile shall 8.4 Devices labelled as sterile

be processed, manufactured,
packaged and, sterilised
by means of appropriate,
validated methods.
11.6 Devices intended to
be sterilised shall be
manufactured and packaged
in appropriate and controlled
conditions and facilities.
shall be processed,
manufactured, packaged
and, sterilised by means
of appropriate, validated
methods.
8.5 Devices intended to
be sterilised shall be
manufactured and
packaged in appropriate
and controlled conditions
and facilities.
11.7 Packaging systems for non- 8.6 Packaging systems for
sterile devices shall maintain non-sterile devices shall
the integrity and cleanliness maintain the integrity and
of the product and, where the cleanliness of the product
devices are to be sterilised and, where the devices
prior to use, are to be sterilised prior to
use,
11.8 The labelling of the device shall 8.7 The labelling of the device
distinguish between identical shall distinguish between
or similar devices placed on identical or similar devices
the market in both a sterile placed on the market in
and a non-sterile condition both a sterile and a non-
sterile condition
12. Devices incorporating    
a substance considered to
be a medicinal product and
devices that are composed
of substances or of
combinations of substances
that are absorbed by or
locally dispersed in the
human body.
12.1 substance as a medicinal 7.4 substance as a medicinal
product as defined in Article 1 product as defined in
of Directive 2001/83/EC Article 1 of Directive
2001/83/EC
12.2 Annex I to Directive 2001/83/    
EC for substances that are
intended to be introduced
into the human body, :the
evaluation of absorption,
distribution, metabolism,
excretion, local tolerance,
toxicity, interaction with other
devices, medicinal products or
other substances
13. Devices incorporating    
materials of biological origin
13.1 a) donation, procurement 7.4 substance as a medicinal
and testing of the tissues product as defined in
and cells shall be done in Article 1 of Directive
accordance with Directive 2001/83/EC
2004/23/EC
13.1 b) p rocessing, preservation    
and any other handling of
those tissues and cells or
their derivatives shall be
carried out so as to provide
safety for patients
13.1 c) t he traceability system    
for those devices shall
be complementary and
compatible with the
traceability and data
protection requirements laid
down in Directive 2004/23/
EC and in Directive 2002/98/
EC
13.2 Devices manufactured utilising 8.2 Tissues of animal origin
tissues or cells of animal origin, must originate from
or their derivatives, which are animals that have been
non-viable or rendered non- subjected to veterinary
viable the following shall apply: controls and surveillance
‘see comprehensive GSPR adapted to the intended
Checklist) use of the tissues
13.3 For devices manufactured    
utilising non-viable biological
substances other than those
referred to in Sections 13.1
and 13.2, the processing,
preservation, testing and
handling of those substances
shall be carried out so as to
provide safety for patients,
users
14. Construction of devices    
and interaction with their
environment
14.1 device is intended for use 9.1 device constructed in
in combination with other combination with other
devices Connections which device the connection
the user has to handle, such system must be safe
as fluid, gas transfer, electrical and must not impair the
or mechanical coupling, shall specified performances
be designed and constructed of the devices. Any
in such a way as to minimise restrictions on use must be
all possible risks, such as indicated on the label or in
misconnection. the instructions for use.
14.2 a) r educe the risk of injury,   a) reduce the risk of
in connection with their injury, in connection
physical features, including with their physical
the volume/pressure ratio, features, including the
dimensional and where volume/pressure ratio,
appropriate ergonomic dimensional and where
features; appropriate ergonomic
features;
14.2 risks connected with 9.2
reasonably foreseeable
external influences or
environmental conditions, such
as magnetic fields, external
electrical and electromagnetic
effects, electrostatic discharge,
radiation associated with
diagnostic or therapeutic
procedures, pressure, humidity,
temperature, variations in
pressure and acceleration or
radio signal interferences;
14.2 the risks associated with  
the use of the device when
it comes into contact with
materials, liquids, and
substances, including gases,
to which it is exposed during
normal conditions of use;
14.2 e) the risks associated with the 7.6
possible negative interaction
between software and the IT
environment within which it
operates and interacts
14.2 f) t he risks of accidental 9.2
ingress of substances into
the device;
14.2 g) r isks arising where 9.2
maintenance or calibration
are not possible (as with
implants), from ageing of
materials used or loss of
accuracy of any measuring
or control mechanism.
14.3 minimise the risks of fire or 9.3
explosion during normal use
and in single fault condition
risks connected with
reasonably foreseeable
environmental conditions,
such as magnetic
fields, external electrical
influences, electrostatic
discharge, pressure,
temperature or variations
in pressure and
acceleration,
 
Devices must be designed
and manufactured in such
a way as to reduce, as
much as possible, risks
posed by the unintentional
ingress of substances
into the device taking
into account the device
and the nature of the
environment in which it is
intended to be used.
Devices must be designed
and manufactured in
such a way as to remove
or minimize as far as is
possible: the risks of
reciprocal interference with
other devices normally
used in the investigations
or for the treatment given,
risks arising where
maintenance or calibration
are not possible (as with
implants), from ageing of
materials used or loss of
accuracy of any measuring
or control mechanism
minimise the risks of fire
or explosion during normal
use and in single fault
condition
14.4 adjustment, calibration, and
maintenance can be done
safely and effectively.
14.5 the interoperability and
compatibility are reliable and
safe.
14.6 The measurement, monitoring
and display scale must
be designed in line with
ergonomic principles,
14.7 facilitate their safe disposal
and the safe disposal of related
waste substances by the user,
patient or other person
15. Devices with a diagnostic  
or measuring function
15.1 Diagnostic devices and
devices with a measuring
function, shall be designed and
manufactured in such a way as
to provide sufficient accuracy,
precision and stability for their
intended purpose, based on
appropriate scientific and
technical methods. The limits
of accuracy shall be indicated
by the manufacturer.
15.2 The measurements made
by devices with a measuring
function shall be expressed in
legal units conforming to the
provisions of Council Directive
80/181/EEC.
16. Protection against
radiation
16.1 reduce radiation whilst not
restricting the application of
appropriate specified levels
for therapeutic and diagnostic
purposes.
   
13.6 safe combination
10.2 The measurement,
monitoring and display
scale must be designed
in line with ergonomic
principles,
   
 
10.1 Diagnostic devices and
devices with a measuring
function, shall be designed
and manufactured in
such a way as to provide
sufficient accuracy,
precision and stability
for their intended
purpose, based on
appropriate scientific
and technical methods.
The limits of accuracy
shall be indicated by the
manufacturer.
10.3 The measurements
made by devices with a
measuring function shall
be expressed in legal
units conforming to the
provisions of Council
Directive 80/181/EEC.
11.1 reduce radiation whilst not
restricting the application
of appropriate specified
levels for therapeutic and
diagnostic purposes.
16.1 a) The operating instructions 11.4
for devices emitting
hazardous or potentially
hazardous radiation shall
contain detailed information
as to the nature of the
emitted radiation, the means
of protecting the patient
and the user, and on ways
of avoiding misuse and of
reducing the risks inherent to
installation as far as possible
and appropriate. Information
regarding the acceptance
and performance testing, the
acceptance criteria, and the
maintenance procedure shall
also be specified
16.2 Intended radiation / shall be 11.2.1
possible for the user to control
the emissions
16.2 shall be fitted, where possible, 11.2.2
with visual displays and/
or audible warnings of such
emissions.
16.3 Unintended radiation Devices 11.3
shall be designed and
manufactured in such a way
that exposure of patients,
users and other persons to
the emission of unintended,
stray or scattered radiation is
reduced as far as possible.
16.4 Ionising radiation a) Devices  
intended to emit ionizing
radiation shall be designed
and manufactured taking into
account the requirements
of the Directive 2013/59/
Euratom laying down basic
safety standards for protection
against the dangers arising
from exposure to ionising
radiation.
The operating instructions
for devices emitting
radiation must give
detailed information
as to the nature of the
emitted radiation, means
of protecting the patient
and the user and on ways
of avoiding misuse and
of eliminating the risks
inherent in installation.
Intended radiation / shall
be possible for the user to
control the emissions
shall be fitted, where
possible, with visual
displays and/or audible
warnings of such
emissions.
Unintended radiation
Devices shall be designed
and manufactured in such
a way that exposure of
patients, users and other
persons to the emission
of unintended, stray or
scattered radiation is
reduced as far as possible.
 
  a) D
 evices intended to emit 11.5.1
ionising radiation shall be
designed and manufactured
in such a way as to ensure
that, where possible, taking
into account the intended
use, the quantity, geometry
and quality of the radiation
emitted can be varied and
controlled, and, if possible,
monitored during treatment.
  b) Devices emitting ionising 11.5.2
radiation intended for
diagnostic radiology shall be
designed and manufactured
in such a way as to achieve
an image and/or output
quality that are appropriate
to the intended medical
purpose whilst minimising
radiation exposure of the
patient and user.
  c) D
 evices that emit ionising 11.5.3
radiation and are intended
for therapeutic radiology
shall be designed and
manufactured in such a
way as to enable reliable
monitoring and control of the
delivered dose, the beam
type, energy and, where
appropriate, the quality of
radiation.
17. Electronic programmable  
systems — devices that
incorporate electronic
programmable systems and
software that are devices in
themselves
Ionizing radiation:
Devices intended to
emit ionizing radiation
must be designed and
manufactured in such
a way as to ensure
that, where practicable,
the quantity, geometry
and quality of radiation
emitted can be varied
and controlled taking into
account the intended use.
Devices emitting ionizing
radiation intended for
diagnostic radiology
shall be designed and
manufactured in such
a way as to achieve
appropriate image and/
or output quality for the
intended medical purpose
whilst minimizing radiation
exposure of the patient
and user.
Devices emitting ionizing
radiation, intended for
therapeutic radiology
shall be designed and
manufactured in such a
way as to enable reliable
monitoring and control of
the delivered dose, the
beam type and energy
and where appropriate the
quality of radiation.
 
17.1 Devices that incorporate 12.1 Devices incorporating
electronic programmable electronic programmable
systems, including software, systems must be
or software that are devices in designed to ensure the
themselves, shall be designed repeatability, reliability
to ensure repeatability, and performance of these
reliability and performance systems according to the
in line with their intended intended use. In the event
use. In the event of a single of a single fault condition
fault condition, appropriate (in the system) appropriate
means shall be adopted to means should be adopted
eliminate or reduce as far as to eliminate or reduce as
possible consequent risks or far as possible consequent
impairment of performance. risks.
17.2 For devices that incorporate 12.1 a For devices which
software or for software that incorporate software
are devices in themselves, or which are medical
the software shall be software in themselves,
developed and manufactured the software must be
in accordance with the state validated according to the
of the art taking into account state of the art taking into
the principles of development account the principles of
life cycle, risk management, development lifecycle, risk
including information security, management, validation
verification and validation. and verification.
17.3 Software referred to in this    
Section that is intended to
be used in combination with
mobile computing platforms
shall be designed and
manufactured taking into
account the specific features
of the mobile platform (e.g.
size and contrast ratio of
the screen) and the external
factors related to their use
(varying environment as
regards level of light or noise).
17.4 Manufacturers shall set    
out minimum requirements
concerning hardware, IT
networks characteristics
and IT security measures,
including protection against
unauthorised access,
necessary to run the software
as intended.
18. Active devices and    
devices connected to them
18.1 Active devices and devices
connected to them For non-
implantable active devices,
in the event of a single fault
condition, appropriate means
shall be adopted to eliminate
or reduce as far as possible
consequent risks.
18.2 Devices where the safety
of the patient depends on
an internal power supply
shall be equipped with a
means of determining the
state of the power supply
and an appropriate warning
or indication for when the
capacity of the power
supply becomes critical. If
necessary, such warning or
indication shall be given prior
to the power supply becoming
critical.
18.3 Devices where the safety
of the patient depends on
an internal power supply
shall be equipped with a
means of determining the
state of the power supply
and an appropriate warning
or indication for when the
capacity of the power
supply becomes critical. If
necessary, such warning or
indication shall be given prior
to the power supply becoming
critical.
18.4 Devices intended to
monitor one or more clinical
parameters of a patient shall
be equipped with appropriate
alarm systems to alert the user
of situations which could lead
to death or severe deterioration
of the patient’s state of health
12.6 Protection against
electrical risks: Devices
must be designed and
manufactured in such a
way as to avoid, as far
as possible, the risk of
accidental electric shocks
during normal use and
in single fault condition,
provided the devices are
installed correctly.
12.2 Devices where the safety
of the patients depends on
an internal power supply
must be equipped with a
means of determining the
state of the power supply.
12.2 Devices where the safety
of the patients depends on
an internal power supply
must be equipped with a
means of determining the
state of the power supply.
12.4 Devices intended to
monitor one or more
clinical parameters of a
patient must be equipped
with appropriate alarm
systems to alert the user
of situations which could
lead to death or severe
deterioration of the
patient’s state of health.
18.5 Devices shall be designed 12.5 Devices must be designed
and manufactured in such a and manufactured in such
way as to reduce as far as a way as to minimize
possible the risks of creating the risks of creating
electromagnetic interference electromagnetic fields
which could impair the which could impair the
operation of the device in operation of other devices
question or other devices or or equipment in the usual
equipment in the intended environment.
environment.
18.6 Devices shall be designed and    
manufactured in such a way
as to provide a level of intrinsic
immunity to electro magnetic
interference such that is
adequate to enable them to
operate as intended.
18.7 Devices shall be designed and 12.6 Protection against
manufactured in such a way electrical risks : Devices
as to avoid, as far as possible, must be designed and
the risk of accidental electric manufactured in such a
shocks to the patient, user or way as to avoid, as far
any other person, both during as possible, the risk of
normal use of the device accidental electric shocks
and in the event of a single during normal use and
fault condition in the device, in single fault condition,
provided the device is installed provided the devices are
and maintained as indicated by installed correctly.
the manufacturer.
18.8 Devices shall be designed and    
manufactured in such a way as
to protect, as far as possible,
against unauthorised access
that could hamper the device
from functioning as intended.
    -  
19. Particular requirements    
for active implantable
devices
19.1 Active implantable devices   See Essential
shall be designed and Requirements of Directive
manufactured in such a way as 90/385/EEC
to remove or minimize as far as
possible:
a) r isks connected with the
use of energy sources
with particular reference,
where electricity is used, to
insulation, leakage currents
and overheating of the
devices,
b) r isks connected with
medical treatment, in
particular those resulting
from the use of defibrillators
or high- frequency surgical
equipment, and
c) r isks which may arise where
maintenance and calibration
are impossible, including:
-e
 xcessive increase of leakage
currents,
-a
 geing of the materials used,
-e
 xcess heat generated by the
device,
-d ecreased accuracy of
any measuring or control
mechanism.
19.2 Active implantable devices   See Essential
shall be designed and Requirements of Directive
manufactured in such a way as 90/385/EEC
to ensure
- if applicable, the compatibility
of the devices with the
substances they are intended
to administer, and
- the reliability of the source of
energy
19.3 Active implantable devices   See Essential
and, if appropriate, their Requirements of Directive
component parts shall be 90/385/EEC
identifiable to allow any
necessary measure to be taken
following the discovery of a
potential risk in connection
with the devices or their
component parts. -
19.4 Active implantable devices
shall bear a code by which
they and their manufacturer
can be unequivocally identified
(particularly with regard to the
type of device and its year
of manufacture); it shall be
possible to read this code, if
necessary, without the need for
a surgical operation.
20. Protection against
mechanical and thermal
risks
20.1 Devices shall be designed
and manufactured in such a
way as to protect patients and
users against mechanical risks
connected with, for example,
resistance to movement,
instability and moving parts.
20.2 Devices shall be designed and
manufactured in such a way
as to reduce to the lowest
possible level the risks arising
from vibration generated by
the devices, taking account of
technical progress and of the
means available for limiting
vibrations, particularly at
source, unless the vibrations
are part of the specified
performance.
20.3 Devices shall be designed and
manufactured in such a way
as to reduce to the lowest
possible level the risks arising
from the noise emitted, taking
account of technical progress
and of the means available
to reduce noise, particularly
at source, unless the noise
emitted is part of the specified
performance.
  See Essential
Requirements of Directive
90/385/EEC
   
12.7.1 Devices must be designed
and manufactured in
such a way as to protect
the patient and user
against mechanical
risks connected with,
for example, resistance,
stability and moving parts
12.7.2 Devices must be designed
and manufactured in such
a way as to reduce to the
lowest possible level the
risks arising from vibration
generated by the devices,
taking account of technical
progress and of the means
available for limiting
vibrations, particularly
at source, unless the
vibrations are part of the
specified performance.
12 .7.3 Devices must be designed
and manufactured in such
a way as to reduce to the
lowest possible level the
risks arising from the noise
emitted, taking account
of technical progress and
of the means available to
reduce noise, particularly
at source, unless the
noise emitted is part of the
specified performance.
20.4 Terminals and connectors to 12.7.4 Terminals and connectors
the electricity, gas or hydraulic to the electricity, gas or
and pneumatic energy supplies hydraulic and pneumatic
which the user or other energy supplies which
person has to handle, shall be the user has to handle
designed and constructed in must be designed and
such a way as to minimize all constructed in such a way
possible risks. as to minimize all possible
risks.
20.5 Errors likely to be made when    
fitting or refitting certain parts
which could be a source of risk
shall be made impossible by
the design and construction
of such parts or, failing this,
by information given on the
parts themselves and/or their
housings.
The same information shall be
given on moving parts and/
or their housings where the
direction of movement needs
to be known in order to avoid
a risk.
20.6 Accessible parts of devices 12.7.5 Accessible parts of the
(excluding the parts or areas devices (excluding the
intended to supply heat or parts or areas intended
reach given temperatures) and to supply heat or reach
their surroundings shall not given temperatures) and
attain potentially dangerous their surroundings must
temperatures under normal not attain potentially
conditions of use. dangerous temperatures
under normal use
21. Protection against the    
risks posed to the patient or
user by devices supplying
energy or substances
21.1 Devices for supplying the 12.8 Devices for supplying
patient with energy or 12.8.1 the patient with energy
substances shall be designed or substances shall be
and constructed in such a way designed and constructed
that the amount to be delivered in such a way that the
can be set and maintained amount to be delivered
accurately enough to ensure can be set and maintained
the safety of the patient and of accurately enough to
the user. ensure the safety of the
patient and of the user.
21.2 Devices shall be fitted with the 12.8.2 Devices shall be fitted with
means of preventing and/or the means of preventing
indicating any inadequacies in and/or indicating any
the amount of energy delivered inadequacies in the
or substances delivered which amount of energy
could pose a danger. Devices delivered or substances
shall incorporate suitable delivered which could
means to prevent, as far as pose a danger. Devices
possible, the accidental release shall incorporate suitable
of dangerous levels of energy means to prevent, as far
or substances from an energy as possible, the accidental
and/or substance source release of dangerous levels
of energy or substances
from an energy and/or
substance source
21.3 The function of the controls 12.8.3 The function of the
and indicators shall be controls and indicators
clearly specified on the shall be clearly specified
devices. Where a device on the devices. Where a
bears instruction required device bears instruction
for its operation or indicates required for its operation
operating or adjustment or indicates operating or
parameters by means of a adjustment parameters by
visual system, such information means of a visual system,
shall be understandable to the such information shall be
user and, as appropriate, the understandable to the user
patient. and, as appropriate, the
patient.
22. Protection against the    
risks posed by medical
devices intended by the
manufacturer for use by lay
persons
22.1 Devices for use by lay persons    
shall be designed and
manufactured in such a way
that they perform appropriately
for their intended purpose
taking into account the skills
and the means available to lay
persons and the influence
resulting from variation that
can be reasonably anticipated
in the layperson’s technique
and environment. The
information and instructions
provided by the manufacturer
shall be easy for the lay person
to understand and apply
22.2 Devices for use by lay persons    
shall be designed and
manufactured in such a way
as to:
ensure that the device can be
used safely and accurately by
the intended user at all stages
of the procedure, if necessary
after appropriate training and/
or information, reduce, as far
as possible and appropriate,
the risk from unintended cuts
and pricks such as needle
stick injuries, and reduce as
far as possible the risk of error
by the intended user in the
handling of the device and, if
applicable, in the interpretation
of the results.

Chapter-III REQUIREMENTS REGARDING THE INFORMATION

SUPPLIED WITH THE DEVICE
23. Label and instruction for use

GSPR (MDR) ER (MDD) OK KO Action

Plan
23.1 General requirements -  
regarding the information
supplied by the manufacturer
Each device shall be
accompanied by the
information needed to
identify the device and its
manufacturer, and by any
safety and performance
information relevant to the
user, or any other person, as
appropriate. Such information
may appear on the device
itself, on the packaging or in
the instructions for use, and
shall, if the manufacturer has
a website, be made available
and kept up to date on the
website, taking into account
the following:
23.1 a) The medium, format, -  
content, legibility, and
location of the label and
instructions for use shall be
appropriate to the particular
device, its intended
purpose and the technical
knowledge, experience,
education or training of
the intended user(s). In
particular, instructions for
use shall be written in terms
readily understood by the
intended user and, where
appropriate, supplemented
with drawings and diagrams.
23.1     Information supplied by
the manufacturer
    Each device must be
accompanied by the
information needed to
use it safely and properly,
taking account of the
training and knowledge of
the potential users, and to
identify the manufacturer.
a) T
 he information required on 13.1  
the label shall be provided
on the device itself. If
this is not practicable or
appropriate, some or all
of the information may
appear on the packaging
for each unit, and/or on
the packaging of multiple
devices.
    This information comprises
the details on the label and
the data in the instructions
for use.
    As far as practicable
and appropriate, the
information needed to use
the device safely must be
set out on the device itself
and/or on the packaging
for each unit or, where
appropriate, on the sales
packaging. If individual
packaging of each unit
is not practicable, the
information must be set
out in the leaflet supplied
with one or more devices.
23.1    
23.1 b) L abels shall be provided in -
a human-readable format
and may be supplemented
by machine-readable
information, such as radio-
frequency identification
(‘RFID’) or bar codes.
23.1 a) Instructions for use shall 13.1
be provided together
with devices. By way of
exception, instructions for
use shall not be required
for class I and class IIa
devices if such devices can
be used safely without any
such instructions and unless
otherwise provided for
elsewhere in this Section.
Instructions for use
must be included in
the packaging for
every device. By way
of exception, no such
instructions for use are
needed for devices in
Class I or IIa if they can be
used safely without any
such instructions.
 
Each device must be
accompanied by the
information needed to
use it safely and properly,
taking account of the
training and knowledge of
the potential users, and to
identify the manufacturer.
This information comprises
the details on the label and
the data in the instructions
for use.
As far as practicable
and appropriate, the
information needed to use
the device safely must be
set out on the device itself
and/or on the packaging
for each unit or, where
appropriate, on the sales
packaging. If individual
packaging of each unit
is not practicable, the
information must be set
out in the leaflet supplied
with one or more devices.
Instructions for use
must be included in
the packaging for
every device. By way
of exception, no such
instructions for use are
needed for devices in
Class I or IIa if they can be
used safely without any
such instructions.
23.1 b) Where multiple devices are -  
supplied to a single user
and/or location, a single
copy of the instructions for
use may be provided if so
agreed by the purchaser
who in any case may
request further copies to be
provided free of charge.
23.1 c Instructions for use may be -  
provided to the user in non-
paper format (e.g. electronic)
to the extent, and only under
the conditions, set out in
Regulation (EU) No 207/2012
or in any subsequent
implementing rules adopted
pursuant to this Regulation.
23.1 d) Residual risks which -  
are required to be
communicated to the user
and/or other person shall
be included as limitations,
contra-indications,
precautions or warnings in
the information supplied by
the manufacturer.
23.1 h) W here appropriate, the 13.2 Where appropriate, this
information supplied by information should take
the manufacturer shall take the form of symbols. Any
the form of internationally symbol or identification
recognised symbols. Any colour used must conform
symbol or identification to the harmonized
colour used shall conform to standards. In areas for
the harmonised standards which no standards exist,
or CS. In areas for which no the symbols and colours
harmonised standards or must be described in the
CS exist, the symbols and documentation supplied
colours shall be described in with the device.
the documentation supplied
with the device.
23.2 Information on the label    
The label shall bear all of the
following particulars:
a) t he name or trade name of
the device;
23.2 b) t he details strictly necessary 13.3
for a user to identify the
device, the contents of the
packaging and, where it is
not obvious for the user,
the intended purpose of the
device;
13.4
23.2 c)      the name, registered 13.3
trade name or registered trade
mark of the manufacturer and
the address of its registered
place of business;
23.2 d) if the manufacturer has its 13.3
registered place of business
outside the Union, the
name of the authorised rep
resentative and address
of the registered place of
business of the authorised
representative;
The label must bear the
following particulars: (…)
b) the details strictly
necessary to identify the
device and the contents
of the packaging
especially for the users;
If the intended purpose
of the device is not
obvious to the user, the
manufacturer must clearly
state it on the label and in
the instructions for use.
a) the name or trade
name and address of
the manufacturer. For
devices imported into
the Community, in view
of their distribution
in the Community,
the label, or the
outer packaging, or
instructions for use,
shall contain in addition
the name and address
of the authorised
representative where
the manufacturer does
not have a registered
place of business in the
Community;
a) the name or trade
name and address of
the manufacturer. For
devices imported into
the Community, in view
of their distribution
in the Community,
the label, or the
outer packaging, or
instructions for use,
shall contain in addition
the name and address
of the authorised
representative where
the manufacturer does
not have a registered
place of business in the
Community;
23.2 e) where applicable, an
indication that the device
contains or incorporates:
-a  medicinal substance,
including a human blood or
plasma derivative, or
- t issues or cells, or their
derivatives, of human origin,
or
- t issues or cells of animal
origin, or their derivatives, as
referred to in Regulation (EU)
No 722/2012;
23.2 f) where applicable, information
labelled in accordance with
Section 10.4.5.;
13.3 n) in the case of a device
within the meaning
of Article 1(4a), an
indication that the
device contains a
human blood derivative.
-  
-  
7.5 The devices must
be designed and
manufactured in such
a way as to reduce to a
minimum the risks posed
by substances leaking
from the device. Special
attention shall be given
to substances which are
carcinogenic, mutagenic
or toxic to reproduction,
in accordance with Annex
I to Council Directive
67/548/EEC of 27 June
1967 on the approximation
of laws, regulations
and administrative
provisions relating to the
classification, packaging
and labelling of dangerous
substances (1).
23.2
[if the device incorporates
carcinogenic, mutagenic
or toxic to reproduction,
or endocrine-disrupting
substances in a concentration
higher than 0,1% weight by
weight (w/w)]
23.2 g) t he lot number or the serial
number of the device
preceded by the words
LOT NUMBER or SERIAL
NUMBER or an equivalent
symbol, as appropriate;
23.2 h) t he UDI carrier referred to in
Article 27(4) and Part C of
Annex VII;
If parts of a device (or a
device itself) intended to
administer and/or remove
medicines, body liquids
or other substances to or
from the body, or devices
intended for transport and
storage of such body
fluids or substances,
contain phthalates
which are classified as
carcinogenic, mutagenic
or toxic to reproduction,
of category 1 or 2, in
accordance with Annex I
to Directive 67/548/EEC,
these devices must be
labelled on the device itself
and/or on the packaging
for each unit or, where
appropriate, on the sales
packaging as a device
containing phthalates.
If the intended use of such
devices includes treatment
of children or treatment
of pregnant or nursing
women, the manufacturer
must provide a specific
justification for the use
of these substances with
regard to compliance with
the essential requirements,
in particular of this
paragraph, within the
technical documentation
and, within the instructions
for use, information on
residual risks for these
patient groups and, if
applicable, on appropriate
precautionary measures.
13.3 d) where appropriate, the
batch code, preceded
by the word ‘LOT’, or
the serial number;
-  
23.2 i) an unambiguous indication
of t the time limit for using or
implanting the device safely,
expressed at least in terms of
year and month, where this is
relevant;
23.2 j) where there is no indication
of the date until when it may
be used safely, the date of
manufacture. This date of
manufacture may be included
as part of the lot number or
serial number, provided the
date is clearly identifiable;
23.2 k) an indication of any special
storage and/or handling
condition that applies;
23.2 l) if the device is supplied
sterile, an indication of
its sterile state and the
sterilisation method;
13.3 e) where appropriate, an
indication of the date by
which the device should
be used, in safety,
expressed as the year
and month;
13.3 l) year of manufacture for
active devices other than
those covered by (e).
This indication may be
included in the batch or
serial number;
13.3 i) any special storage and/
or handling conditions;
13.3 c) where appropriate, the
word ‘STERILE’;
13.3 m) where applicable,
method of sterilization;

23.2 m) warnings or precautions to 13.3 k) any warnings and/or

be taken that need to be precautions to take;
brought to the immediate
attention of the user of the
device, and to any other
person. This information
may be kept to a minimum
in which case more detailed
information shall appear
in the instructions for use,
taking into account the
intended users;
23.2 n) if the device is intended for 13.3 f) where appropriate, an
single use, an indication of indication that the device
that fact. A manufacturer’s is for single use. A
indication of single use shall manufacturer’s indication
be consistent across the of single use must be
Union; consistent across the
Community
23.2 o) if the device is a single- -  
use device that has been
reprocessed, an indication
of that fact, the number
of reprocessing cycles
already performed, and any
limitation as regards the
number of reprocessing
cycles;
23.2 p) if the device is custom- 13.3 g) if the device is custom-
made, the words ‘custom- made, the words
made device’; ‘custom-made device’
23.2 q) a  n indication that the device 13.3 h) if the device is
is a medical device. If intended for clinical
the device is intended for investigations, the
clinical investigation only, words ‘exclusively for
the words ‘exclusively for clinical investigations’;
clinical investigation’;
23.2 r) in the case of devices that -  
are composed of substances
or of combinations of
substances that are intended
to be introduced into the
human body via a body
orifice or applied to the skin
and that are absorbed by
or locally dispersed in the
human body, the overall
qualitative composition of
the device and quantitative
information on the main
constituent or constituents
responsible for achieving the
principal intended action;
PART 2: CONCLUSION ON THE FLASH GSPR AUDIT: