EN ISO 15223-1:2021/A1:2025

SLOVENSKI STANDARD
01-januar-2026
Medicinski pripomočki - Simboli za označevanje podatkov, ki jih mora zagotoviti
dobavitelj - 1. del: Splošne zahteve - Dopolnilo 1: Dodajanje opredeljenega izraza
za pooblaščenega zastopnika in sprememba simbola EC REP, ne da bi bil ta vezan
na točno določeno državo ali regijo (ISO 15223 1:2021/Amd 1:2025)
Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for
authorized representative and modified EC REP symbol to not be country or region
specific (ISO 15223 1:2021/Amd 1:2025)
Medizinprodukte - Symbole zur Verwendung im Rahmen der vom Hersteller
bereitzustellenden Informationen - Teil 1: Allgemeine Anforderungen - Änderung 1 (ISO
15223 1:2021/Amd 1:2025)
Dispositifs médicaux - Symboles à utiliser avec les informations à fournir par le fabricant
- Partie 1: Exigences générales - Amendement 1: Ajout du terme défini représentant
autorisé (mandataire) et modification du symbole EC REP pour ne pas être spécifique
d’un pays ou d’une région (ISO 15223 1:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2021/A1:2025
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 15223-1:2021/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2025
ICS 11.040.01; 01.080.20
English version
Medical devices - Symbols to be used with information to
be supplied by the manufacturer - Part 1: General
requirements - Amendment 1: Addition of defined term for
authorized representative and modified EC REP symbol to
not be country or region specific (ISO 15223 1:2021/Amd
1:2025)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Symbole zur Verwendung im
informations à fournir par le fabricant - Partie 1: Rahmen der vom Hersteller bereitzustellenden
Exigences générales - Amendement 1: Ajout du terme Informationen - Teil 1: Allgemeine Anforderungen -
défini représentant autorisé (mandataire) et Änderung 1 (ISO 15223 1:2021/Amd 1:2025)
modification du symbole EC REP pour ne pas être
spécifique d'un pays ou d'une région (ISO 15223
1:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 15223-1:2021; it was approved by CEN on 16 September 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative)  Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 18

European foreword
This document (EN ISO 15223-1:2021/A1:2025) has been prepared by Technical Committee ISO/TC
210 "Quality management and corresponding general aspects for products with a health purpose
including medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3 “Quality
management and corresponding general aspects for medical devices” the secretariat of which is held by
NEN.
This Amendment to the European Standard EN ISO 15223-1:2021 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2026, and
conflicting national standards shall be withdrawn at the latest by May 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CEN and CENELEC by
the European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA and ZB, which are an integral parts
of this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15223-1:2021/Amd 1:2025 has been approved by CEN-CENELEC as EN ISO 15223-
1:2021/A1:2025 without any modification.

Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
4 (c) 5.2.6 Partially covered: used to draw user’s attention
on the label to the safety information such as
5.2.7
warnings/precautions/contraindications only for
5.2.8
the aspects dealt with by these symbols placed in
5.3.1
the instructions for use or accompanying
5.3.2
information and of any residual risks and need
for training for users.
5.3.3
5.3.4
Not covered: does not provide further
5.3.5
information for safety about
5.3.6
warning/precautions/contraindications other
5.3.7
than the ones dealt with by these symbols, nor
5.3.8
training.
5.3.9
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.4.11
5.4.12
10.4.5 5.4.3 Partially covered: used to draw user’s attention
on the label to the safety information placed in
5.4.10
the instructions for use or accompanying
information of the presence of substances that
are carcinogenic, mutagenic, toxic to
reproduction and/or having endocrine-
disrupting properties.
11.3 5.2.1 Partially covered: used as part of the label to
identify sterile or non-sterile medical devices.
5.2.2
5.2.3
Not covered: Design, manufacture, and
5.2.4
packaging.
5.2.5
5.2.7
5.2.10
11.8 5.2.1 Covered: used as part of the label to distinguish
between identical sterile and non-sterile medical
5.2.3
devices.
5.2.4
5.2.5
5.2.7
5.2.10
14.1 5.4.3 Partially covered: used to draw user’s attention
on the labelling to the safety information in the
5.4.4
instructions for use.
22.1 5 Partially covered: used to convey specific label
information in a format that is easy for the
intended user to understand.
Not covered: the design and manufacture for
appropriate performance, taking user’s skills into
account; the understanding and application of
the instructions for use.
23.1 (first sentence) 5.1.1 Partially covered: used to identify the medical
device and its manufacturer.
5.1.3
5.1.5
5.1.6
5.1.7
5.1.10
5.1.11
23.1 (a) 5 Partially covered: used to convey label
information in a format that is easy to
understand.
Not covered: the medium, format, content,
legibility and location of the label, instructions
for use, and accompanying information; the
technical knowledge, experience, and training of
the intended user; understanding of the intended
use, drawings, or diagrams.
23.1 (b) 5 Partially covered: used to provide label
information directly on a medical device in a
symbol format that would be otherwise
impracticable by use of text.
Not covered: the information that is required on
the label and/or medical device, but that can be
placed on the medical device or the packaging.
23.1 (c) 5 Partially covered: used to provide label
information in a human readable format that
would be otherwise impracticable by use of text.

Not covered: machine-readable information.
23.1 (g) 5.4.3 Partially covered: may be used to draw user’s
attention on the label to the safety information
5.4.4
concerning limitation, contra-indications,
precautions, or warnings.
Not covered: the residual risks required to be
communicated by way of limitations, contra-
indications, precautions, or warnings.
23.1 (h) 4.2 Covered: symbols used to convey information in
combination with risk management. Symbols
addressed in 5 are used on labels without a
description of the symbol required in the
instructions for use or accompanying
information to convey information.

Not covered: the use of other symbols will
require a description of the symbol in the
instructions for use or accompanying
information.
23.2 (b) 5.1.6 Partially covered: used as part of the label
information to identify the medical device and
5.1.10
the packaging contents.
5.7.10
Not covered: the intended purpose of the medical
device.
23.2 (c) 5.1.1 Partially covered: used as part of the label
information to identify the manufacturer and

registered place of business (address).

Not covered: the trade name or registered
trademark.
23.2 (d) 5.1.2 Covered: used as part of the label information to
identify the authorised representative and
registered place of business (address).
23.2 (e) 5.4.6 Covered: used as part of the label information to
identify that the medical device contains or
5.4.7
incorporates a medicinal substance, including a
5.4.8
human blood or plasma derivative; or tissues or
5.4.9
cells, or their derivatives, of human origin; or
tissues or cells of animal origin, or their
derivatives.
23.2 (f) 5.4.3 Partially covered: used to draw user’s attention
5.4.10 on the label to the safety information placed in
the instructions for use or accompanying
information of the presence of substances that
are carcinogenic, mutagenic, toxic to
reproduction and/or have endocrine-disrupting
properties.
23.2 (g) 5.1.5 Covered: used to replace the words ‘LOT
NUMBER’ and ‘SERIAL NUMBER’
5.1.7
23.2 (h) 5.7.10 Partially covered: symbol used to indicate the
UDI carrier
23.2 (i) 5.1.4 Covered: used to indicate the time limit for use or
implant of the medical device, accompanied by
the date (to include at least year and month).
23.2 (j) 5.1.3 Covered: used to indicate the date of
manufacture for the medical device,
5.1.11
accompanied by the date (to include at least year
and month).
23.2 (k) 5.3.1 Covered: used to indicate information that the
medical device is:
5.3.2
fragile.
5.3.3
restricted for safety by exposure to the indicated
5.3.4
lower limit temperature value.
5.3.5
needs protection from sunlight and other light
5.3.6
sources, or heat and radioactive sources, or
5.3.7
moisture.
5.3.8
5.3.9
Partially covered: used to indicate that for safe

use and effectiveness the medical device has:
an upper limit of temperature accompanied by
the temperature value.
upper and lower limits of temperature
accompanied by the upper and lower
temperature values.
upper and lower limits of humidity accompanied
by the upper and lower humidity values.
upper and lower limits of pressure accompanied
by the upper and lower pressure values.
23.2 (l) 5.2.1 Covered: used on the label to specify an
indication of the medical device’s sterile state
5.2.2
and the method of sterilization.
5.2.3
5.2.4
If symbol 5.2.1 is used, the GSPR is only partially
5.2.5
covered as this symbol does not indicate the
5.2.10
method of sterilization.
23.2 (m) 5.2.6 Partially covered: used to draw user’s attention
on the label to the more detailed warnings or
5.2.7
precautions found in the instructions for use or
5.2.8
accompanying information.
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.10
23.2 (n) 5.4.2 Covered: used to specify on the label that the
medical device is intended for single use.

23.2 (q) 5.7.7 Covered: used to specify on the label that the
device is a medical device.
Not covered: for labelling of devices intended for
clinical use only.
23.2 (s) 5.1.5 Covered: used to replace the words ‘LOT
NUMBER’ and ‘SERIAL NUMBER’
5.1.7
23.3 (a) 5.2.11 Covered: used to specify on the label of the
medical device that the packaging is sterile
5.2.12
packaging (sterile barrier system).
5.2.13
5.2.14
23.3 (b) 5.2.1 Covered: used as part of the label to identify the
medical device is sterile.
5.2.2
5.2.3
5.2.4
5.2.5
5.2.10
23.3 (c) 5.2.2 Covered: used to specify on the label the method
of sterilization.
5.2.3
5.2.4
5.2.5
5.2.10
23.3 (d) 5.1.1 Covered: used as part of the label information to
identify the manufacturer and registered place of
business (address).
23.3 (h) 5.1.3 Covered: used to indicate the date of
manufacture for the medical device,
5.1.11
accompanied by the date (to include at least year
and month).
23.3 (i) 5.1.4 Covered: used to indicate the time limit for use or
implant of the medical device, accompanied by
the date (to include at least year and month).
23.3 (j) 5.2.8 Covered: used to draw user’s attention on the
label to the more detailed warnings or
5.4.3
precautions found in the instructions for use or
accompanying information if the packaging is
damaged or opened.
23.4 (a) 5.1.1 Covered: used as part of the label information to
identify that the medical device contains or
5.2.1
incorporates:
5.2.2
a medicinal substance, including a human blood
5.2.3
or plasma derivative (23.2 (e)).
5.2.4
tissues or cells, or their derivatives, of human
5.2.5
origin (23.2 (e)).
5.2.10
tissues or cells of animal origin, or their
5.3.1
derivatives (23.2 (e)).
5.3.2
5.3.3
Covered: used to indicate information that the
medical device is:
5.3.4
fragile (23.2 (k)).
5.3.5
restricted for safety by exposure to the indicated
5.3.6
lower limit temperature value, (23.2 (k)).
5.3.7
needs protection from sunlight and other light
5.3.8
sources, or heat and radioactive sources, or
5.3.9
moisture (23.2 (k)).
5.4.2
intended for single use (23.2 (n)).
5.4.3
5.4.4
Covered: used on the label to specify an
5.4.6
indication of the medical device’s sterile state
5.4.7
and the method of sterilization (23.2 (l)).
5.4.8 Partially covered: used to indicate that for safe
use and effectiveness the medical device has:
5.4.9
an upper limit of temperature accompanied by
5.4.10
the temperature value (23.2 (k)).

upper and lower limits of temperature
accompanied by the upper and lower
temperature values (23.2 (k)).
upper and lower limits of humidity accompanied
by the upper and lower humidity values (23.2
(k)).
upper and lower limits of pressure accompanied
by the upper and lower pressure values (23.2
(k)).
Partially covered: used as part of the label
information to identify the manufacturer and
registered place of business (address) (23.2 (c)).

Partially covered: Symbol 5.2.1 is used to
indicate that a medical device is sterile but does
not indicate method of sterilization (23.2(l)).

Partially covered: used to draw user’s attention
on the label to the safety information placed in
the instructions for use or accompanying
information of the presence of substances that
are hazardous, carcinogenic, mutagenic, toxic to
reproduction and/or have endocrine-disrupting
properties (23.2 (f)).
Not covered: the trade name or registered
trademark (23.2 (a)), (23.2 (c)).

Not covered: the method of sterilization is not
specified in symbol 5.2.1 so cannot be used to
meet 23.2(l) (see symbols 5.2.2, 5.2.3, 5.2.4,
5.2.5).
23.4 (l) 5.2.8 Partially covered: used on the label to draw
user’s attention to the more detailed warnings or
5.4.3
precautions found in the instructions for use or
accompanying information if the packaging is
damaged or opened.
Not covered: instructions in the event of damage
or unintentional opening.
23.4 (p) 5.4.2 Partially covered: used on the label to specify
that the medical device is intended for single use.

Not covered: information and technical factors
that could pose a risk if re-used.
23.4 (aa) 5.1.1 Partially covered: used on information provided
to the patient to draw attention to the more
5.1.5
detailed information regarding the implanted
5.1.7
medical device.
5.1.10
5.7.3
Not covered: specific information regarding the
5.7.4 implanted medical device.
5.7.5
5.7.6
5.7.7
5.7.10
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
Table ZA.2 — Normative references from clause 2 of this document and their corresponding
European publications
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Title Corresponding European
Clause 2
Standard Edition
ISO 8601-1 ISO 8601-1:2019 Date and time — -
Representations for information
ISO 8601-
interchange Part 1: Basic rules
1:2019/A1:2022
ISO 8601-2 ISO 8601-2:2019 Date and time — -
Representations for information
interchange
Part 2: Extensions
ISO 15223-2 ISO 15223-2:2010 Medical devices — Symbols to be -
used with medical device labels,
labelling, and information to be
supplied
Part 2: Symbol development,
selection and validation
ISO 3166-1 ISO 3166-1: 2020 Codes for the representation of EN ISO 3166-1:2020
names of countries and their
subdivisions
Part 1: Country code
Table ZA.3 — Terms and definitions from clause 3 of this document which differ from a
definition of the same term set out in Regulation (EU) 2017/745
Reference Definition in Regulation (EU) Reference Definition in Clause 3
in 2017/745 in Clause 3
Regulation
(EU)
2017/745
2.1 ‘medical device’ means any 3.12 medical device
instrument, apparatus,
instrument, apparatus, implement,
appliance, software, implant,
machine, appliance, implant,
reagent, material or other
reagent for in vitro use, software,
article intended by the
material or other similar or related
manufacturer to be used, alone
article, intended by the
or in combination, for human
manufacturer to be used, alone or
beings for one or more of the
in combination, for human beings,
following specific medical
for one or more of the specific
purposes:
medical purpose(s) of:
diagnosis, prevention,
diagnosis, prevention, monitoring,
monitoring, prediction,
treatment or alleviation of disease;
prognosis, treatment
diagnosis, monitoring, treatment,
oralleviation of disease,
alleviation of or compensation for
diagnosis, monitoring,
an injury;
treatment, alleviation of, or
compensation for, an injury or investigation, replacement,
disability, modification, or support of the
anatomy or of a physiological
investigation, replacement or
process;
modification of the anatomy or
of a physiological or supporting or sustaining life;
pathological process or state,
control of conception;
providing information by means
disinfection of medical devices;
of in vitro examination of
providing information by means of
specimens derived from the
in vitro examination of specimens
human body, including organ,
derived from the human body;
blood and tissue donations,
and which does not achieve its and does not achieve its primary

principal intended action by intended action by
pharmacological, pharmacological, immunological or
immunological or metabolic metabolic means, in or on the
means, in or on the human human body, but which may be
body, but which may be assisted assisted in its intended function by
in its function by such means. such means
Note 1 to entry: Products which
may be considered to be medical
The following products shall
devices in some jurisdictions but
also be deemed to be medical
not in others
devices:
include:
devices for the control or
support of conception;
disinfection substances;
products specifically intended aids for persons with disabilities;
for the cleaning, disinfection or
devices incorporating animal or
sterilisation of devices as
human tissues, or both;
referred to in Article 1(4) and of
devices for in vitro fertilization or
those referred to in the first
assisted reproduction technologies.
paragraph of this point.
2.13 ‘label’ means the written, 3.8 label
printed or graphic information

appearing either on the device
written, printed or graphic
itself, or on the packaging of
information appearing on the item
each unit or on the packaging of
itself, on the packaging of each
multiple devices;
item, or on the packaging of
multiple items
Note 1 to entry: For the purposes
of this document, the term labelled
is used to designate the
corresponding act.
Note 2 to entry: Label includes the
marking on the medical device or
accessory.
Note 3 to entry: For the purposes
of this document, information
indicated on a graphical user
interface (GUI) is considered as
appearing on the item.
Note 4 to entry: See Figure 1
2.14 ‘instructions for use’ means the 3.7 instructions for use
information provided by the
IFU
manufacturer to inform the user
package insert
of a device’s intended purpose
portion of the accompanying
and proper use and of any
information that is essential for the
precautions to be taken;
safe and effective use of a medical
device or accessory directed to the
user of the medical device
Note 1 to entry: For the purposes
of this document, a user can be
either a lay user or professional
user with relevant specialized
training.
Note 2 to entry: For the purposes
of this document, instructions for
the professional processing
between uses of a medical device
or accessory can be included in the
instructions for use.
Note 3 to entry: The instructions
for use, or portions thereof, can be
located on the display of a medical
device or accessory.
Note 4 to entry: Medical devices or
accessories that can be used safely
and effectively without
instructions for use are exempted
from having instructions for use by
some authorities with jurisdiction.
Note 5 to entry: See Figure 1.
2.30 ‘manufacturer’ means a natural 3.10 manufacturer
or legal person who
natural or legal person with
manufactures or fully
responsibility for the design or
refurbishes a device or has a
manufacture, or both, of a medical
device designed, manufactured
device with the intention of making
or fully refurbished, and
the medical device available for
markets that device under its
use, under his or her name;
name or trademark;
whether or not such a medical
device is designed or
manufactured, or both, by that
person themselves or on their
behalf by another person(s)
Note 1 to entry: The natural or
legal person has ultimate legal
responsibility for ensuring
compliance with all applicable
regulatory requirements for the
medical devices in the countries or
jurisdictions where it is intended
to be made available or sold, unless
this responsibility is specifically
imposed on another person by the
Regulatory Authority (RA) within
that jurisdiction.
Note 2 to entry: The
manufacturer’s responsibilities are
described in other GHTF guidance
documents. These responsibilities
include meeting both pre-market
requirements and post-market
requirements, such as adverse
event reporting and notification of
corrective actions.
Note 3 to entry: “Design or
manufacture, or both”, may include
specification development,
production, fabrication, assembly,
processing, packaging,
repackaging, labelling, relabelling,
sterilization, installation, or
remanufacturing of a medical
device; or putting a collection of
devices, and possibly other
products, together for a medical
purpose.
Note 4 to entry: Any person who
assembles or adapts a medical
device that has already been
supplied by another person for an
individual patient, in accordance
with the instructions for use, is not
the manufacturer, provided the
assembly or adaptation does not
change the intended use of the
medical device
Note 5 to entry: Any person who

changes the intended use of, or
modifies, a medical device without
acting on behalf of the original
manufacturer and who makes it
available for use under his own
name, should be considered the
manufacturer of the modified
medical device.
Note 6 to entry: An authorized
representative, distributor or
importer who only adds its own
address and contact details to the
medical device or the packaging,
without covering or changing the
existing labelling, is not considered
a manufacturer.
Note 7 to entry: To the extent that
an accessory is subject to the
regulatory requirements of a
medical device, the person
responsible for the design,
manufacture, or both, of that
accessory is considered to be a
manufacturer.
2.33 ‘importer’ means any natural or 3.5 importer
legal person established within
natural or legal person who
the Union that places a device
imports a medical device or
from a third country on the
accessory into a locale that was
Uni
...