HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 253/8
EN
Official Journal of the European Union
25.9.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013
of 24 September 2013
on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on
active implantable medical devices and Council Directive 93/42/EEC on medical devices
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Directive 90/385/EEC and Directive 93/42/EEC. Bringing
the discrepancies to the surface will permit to develop a
common interpretation of the assessment methods,
especially with regard to new technologies and devices.
Having regard to the Treaty on the Functioning of the European
Union,
(3) To
ensure
a
common
approach
from
the
designating
authorities and neutral conditions for competition those
Having regard to Council Directive 90/385/EEC of 20 June
authorities should base their decisions on a common set
1990 on the approximation of the laws of the Member States
of documents which lay the ground for the verification
relating to active implantable medical devices ( 1 ), and in
of the criteria for designation set out in Directive
particular Article 11(2) thereof,
90/385/EEC and Directive 93/42/EEC.
Having regard to Council Directive 93/42/EEC of 14 June 1993
(4) To
facilitate,
in
a
view
of
the
increasingly
complex
work
concerning medical devices (
of conformity assessment bodies, a common application

2 ), and in particular Article 16(2)
thereof,
of the criteria established for their designation, those
bodies should be assessed by teams of assessors repre
senting the knowledge and experience of different
Member States and of the Commission. To facilitate
Whereas:
such assessments, certain essential documents should be

accessible to those involved in these activities. Desig
nating authorities from Member States other than the
Member State where the conformity assessment body is
(1) Technical
progress
has
led
to
more
complex
devices
and
established should have the possibility to review the
production methods implying new conformity
documentation related to the assessment and to
assessment challenges for notified bodies. Those devel
comment on intended designations if they so wish. The
opments have resulted in variations in the level of
access to those documents is necessary in order to allow
competence of notified bodies and in different degrees
the identification of weaknesses of the applicant
of stringency applied by them. Accordingly, to ensure the
conformity assessment bodies as well as discrepancies
smooth functioning of the internal market, it is necessary
in the Member States’ assessment methods and in their
to determine a common interpretation of the main
interpretation of the criteria for designation set out in
elements of the criteria for designation of notified
Directive 90/385/EEC and Directive 93/42/EEC.
bodies set out in Directive 90/385/EEC and Directive
93/42/EEC.
(5) In
order
to
ensure
that
the
common
interpretation
of
the
criteria established applies similarly to scope extensions,
which often reflect new technologies or product types
(2) The
common
interpretation
of
the
criteria
for
designation
and renewal of designations of notified bodies, the
provided by this Regulation does not suffice to assure
procedure for the designation of conformity assessment
their consistent application. The assessment methods in
bodies should also be followed in those situations.
the Member States differ. They have a tendency to differ
ever more due to the mentioned increased complexity of
the work of conformity assessment bodies. Furthermore,
many ad hoc questions arise in the day-to-day desig
(6)
The need for control and monitoring of notified bodies
nation practice, in relation with new technologies and
by the designating authorities has increased since
products. For these reasons, it is necessary to provide
technical progress has raised the risk that notified
for procedural obligations which ensure a constant
bodies do not possess the necessary competence with
dialogue between Member States on their general
regard to new technologies or devices emerging within
practices and on ad hoc questions. This will bring to
their scope of designation. As technical progress shortens
the surface discrepancies in the methods used to assess
product cycles and as the intervals of surveillance on-site
the conformity assessment bodies and in the interpre
assessments and of the monitoring vary between desig
tation of the criteria for their designation set out in
nating authorities, minimum requirements with regard to
the intervals of the surveillance and monitoring of the
( 1 ) OJ L 189, 20.7.1990, p. 17.
notified bodies should be established and unannounced
( 2 ) OJ L 169, 12.7.1993, p. 1.
or short-notice on-site assessments should be organised.

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/9
(7) When,
in
spite
of
the
measures
taken
to
ensure
a
ability to cover those technologies and devices and thus
coherent application and follow up of the requirements
to fulfil the criteria for designation set out in Directive
by the Member States, the competence of a notified body
90/385/EEC and Directive 93/42/EEC.
is in doubt, the Commission should have the possibility
to investigate individual cases. The need for investigation
(12) It
is
appropriate
to
provide
for
a
phase-in
period,
so
as
to
by the Commission is exacerbated since technical
give designating authorities time to build up the
progress has increased the risk that notified bodies do
necessary additional resources and adapt their
not possess the necessary competence with regard to new
procedures.
technologies or products falling under their scope of
designation.
(13) The
complex
technical and production developments
have led some notified bodies to outsource parts of
their assessments. It is therefore necessary to set the
(8)
In order to increase transparency and mutual trust and to
limits and to determine under which conditions this
further align and develop their designation, extension and
can be done. Notified bodies should be in control of
renewal procedures, above all in a view of new emerging
their subcontractors and of their subsidiaries. They need
interpretative questions regarding new technologies and
to be endowed with the appropriate resources, including
devices, Member States should cooperate with each other
fully qualified staff to make their own assessments or to
and with the Commission. They should consult each
review the assessments made by external experts.
other and the Commission on questions with general
relevance for the implementation of this Regulation
and inform each other and the Commission on their
(14) To
ensure
that
decisions
by
notified
bodies
are
not
model assessment checklist, which constitutes the basis
influenced by non-legitimate circumstances the organi
for their assessment practice.
sation and operation of the bodies should ensure full

impartiality. To be able to carry out their tasks in a
coherent and systematic manner the bodies should
possess a satisfactory management system including
(9) The
increased
complexity
of
the
tasks
regarding
the
provisions on professional secrecy. In order to allow
designation of the conformity assessment bodies,
notified bodies to perform their work properly, the
reflecting the increasing complexity of the work of
level of knowledge and competence of the personnel
those bodies, requires significant resources. Therefore,
should be guaranteed at all times.
requirements should be imposed on the Member States
with regard to the minimum level of available competent
personnel, able and entrusted to operate in an inde
(15) The
measures
provided
for
in
this
Regulation
are
in
pendent way.
accordance with the opinion of the Committee set up

by Article 6(2) of Directive 90/385/EEC,
HAS ADOPTED THIS REGULATION:
(10) Designating
authorities
who
are
not
in
charge
of
market
surveillance and vigilance for medical devices are not
necessarily aware of deficiencies in the work of notified
Article 1
bodies which were spotted by the competent authorities
when doing product checks. Furthermore, the designating
Definitions
authorities do not necessarily have all the product related
For the purposes of this Regulation, the following definitions
knowledge which is sometimes needed to assess whether
shall apply:
the notified bodies worked properly. Therefore, the desig
nating authorities should consult the competent auth
(a) ‘device’ means active implantable medical devices as defined
orities.
in Article 1(2)(c) of Directive 90/385/EEC or medical
devices and their accessories as defined in Article 1(2) of
Directive 93/42/EEC;
(11) Where
designation is based on accreditation in the
meaning of Regulation (EC) No
765/2008 of the
(b) ‘conformity assessment body’ means a body which performs
European Parliament and of the Council of 9 July
calibration, testing, certification and inspection activities
2008 setting out the requirements for accreditation and
under Article R1(13) in Annex I to Decision No 768/
market surveillance relating to the marketing of products
2008/EC of the European Parliament and of the Council (
and repealing Regulation (EEC) No 339/93 (

2 );

1 ), in order to
ensure a transparent and coherent application of the
criteria set out in Annex 8 to Directive 90/385/EEC
(c) ‘notified body’ means a conformity assessment body which
and Annex XI to Directive 93/42/EEC, accreditation
has been notified by a Member State in accordance with
bodies on the one hand, and designating and
Article 11 of Directive 90/385/EEC or Article 16 of
competent authorities on the other hand should
Directive 93/42/EEC;
exchange information relevant for the assessment of
notified bodies. The need for this exchange of
(d) ‘accreditation body’ means the sole body in a Member State
information has proven to be particularly strong in
that performs accreditation with authority derived from the
respect to the conformity assessment bodies’ practices
State as laid down by Article 2(10) of Regulation (EC)
with regard to new technologies and devices and their
No 765/2008;
( 1 ) OJ L 218, 13.8.2008, p. 30.
( 2 ) OJ L 218, 13.8.2008, p. 82.

---

L 253/10
EN
Official Journal of the European Union
25.9.2013
(e) ‘designating authority’ means the authority(ies) entrusted by
2. The
designating
authority
of
the
Member
State
where
the
a Member State to assess, designate, notify and monitor
conformity assessment body is established shall assess that body
notified bodies under Directive 90/385/EEC or Directive
in accordance with an assessment check-list that covers at least
93/42/EEC;
the items listed in Annex II. The assessment shall include an on-
site assessment.
(f) ‘competent authority’ means the authority(ies) in charge of
market surveillance and/or of vigilance for devices;
Representatives of designating authorities of two other Member
(g) ‘on-site assessment’ means a verification in the premises of
States shall, in coordination with the designating authority of
the body or of one of its subcontractors or subsidiaries by
the Member State in which the conformity assessment body is
the designating authority;
established and together with a representative of the
Commission, participate to the assessment of the conformity
(h) ‘surveillance on-site assessment’ means a periodic routine
assessment body, including the on-site assessment. The desig
on-site assessment which is neither the on-site assessment
nating authority of the Member State where the conformity
undertaken for the initial designation, nor the on-site
assessment body is established shall give those representatives
assessment undertaken for the renewal of the designation;
timely access to the documents necessary to assess the
conformity assessment body. They shall produce within 45
(i) ‘observed audit’ means a designating authority's assessment
days after the on-site assessment a report, which shall contain
of the performance of a notified body’s audit team in the
at least a summary of identified non-compliances with the
premises of the body's client;
criteria set out in Annex I and recommendation with regard
to the designation of the notified body.
(j) ‘functions’ means the tasks to be fulfilled by the body’s staff
and its external experts, namely: auditing of the quality
systems, product related technical documentation review,
review of clinical evaluations and investigations, device
3. The
Member
States
shall
make
available
a
pool
of
testing and, for each of the previously mentioned items,
assessors for the Commission to call upon for each assessment.
the final review and decision making thereon;
(k) ‘subcontracting’ means the transfer of tasks to one of the
4. The
designating
authority
of
the
Member
State
where
the
following:
conformity assessment body is established shall upload into a
data storage system managed by the Commission, the
(i) a legal person;
assessment report drafted by the representatives referred to in
paragraph 2, its own assessment report and, if not contained
(ii) a natural person who further delegates these tasks or
therein, an on-site assessment report.
parts thereof;
(iii) several natural or legal persons who jointly perform
5. The
designating
authorities
of
all
the
other
Member
States
these tasks.
shall be informed of the application and may request to get
access to certain or all the documents referred to in paragraph
Article 2
4. Those authorities and the Commission may review all the
documents referred to in paragraph 4, may raise questions or
Interpretation of designation criteria
concerns and may request further documentation within one
The criteria set out in Annex 8 to Directive 90/385/EEC or in
month after the last upload of one of those documents.
Annex XI to Directive 93/42/EEC shall be applied as laid down
Within the same period of time, they may request an
in Annex I.
exchange of views on the application, organised by the
Commission.
Article 3
Procedure for the designation of notified bodies
6. The
designating
authority
of
the
Member
State
where
the
1. When
applying
for
designation
as
a
notified
body,
a conformity assessment body is established shall respond to the
conformity assessment body shall use the application form set
questions, concerns and requests for further documentation
out in Annex II. If the conformity assessment body submits the
within four weeks following their receipt.
application and documents annexed to the application on
paper, it shall also submit an electronic copy of the application
and its annexes.
The designating authorities of the other Member States or the
Commission may individually or jointly address recommen
The application shall specify the conformity assessment activ
dations to the designating authority of the Member State
ities, the conformity assessment procedures and the fields of
where the conformity assessment body is established within
competence for which the conformity assessment body wishes
four weeks following the receipt of the response. That desig
to be notified, the latter by indicating the codes used in the
nating authority shall take account of the recommendations
‘New Approach Notified and Designated Organisations’
when it takes the decision on the designation of the conformity
Information System ( 1 ) and subdivisions of those fields.
assessment body. If it does not follow the recommendations, it
shall give the reasons therefor within two weeks after its
( 1 ) ‘NANDO’; see http://ec.europa.eu/enterprise/newapproach/nando
decision.

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/11
7. The
Member
State
shall
notify
to
the
Commission
its body is established shall initiate unannounced or short-notice
decision on the designation of a conformity assessment body
on-site assessments if those on-site assessments are needed to
by means of the ‘New Approach Notified and Designated
verify compliance.
Organisations’ Information System.
Article 6
The validity of the designation shall be limited up to a
maximum of five years.
Investigation of the competence of a notified body
Article 4
1. The
Commission
may
investigate
cases
regarding
the
competence of a notified body or the fulfilment of the
Extension and renewal of designation
requirements and responsibilities to which a notified body is
subject under Directive 90/385/EEC and Directive 93/42/EEC.
1. An extension of the scope of the notified body's desig
nation may be granted in accordance with Article 3.
2. Investigations
will
start
with
a
consultation
of
the
desig
2. A
designation
as
notified
body
may
be
renewed
in nating authority of the Member State where the notified body is
accordance with Article 3 before the end of the validity
established. Upon request, that designating authority shall,
period of the previous designation.
within four weeks, provide the Commission with all relevant
information concerning the relevant notified body.
3. For the purposes of paragraph 2, the procedure set out in
Article 3(2) shall include, where appropriate, an observed audit.
3. The
Commission
will
ensure
that
all
sensitive
information
obtained in the course of its investigations is treated confiden
4. Extension
and
renewal
procedures
may
be
combined.
tially.
5. Notified
bodies
already
designated
before
the
entry
into
4. When the notified body no longer meets the requirements
force of this Regulation and for which the designation does not
for its notification, the Commission will inform the Member
have a stated validity period or has a validity period exceeding
State where that body is established and may request the
five years, shall be subject to renewal at least within three years
Member State to take the necessary corrective measures.
of entry into force of this Regulation.
Article 7
Article 5
Exchange of experience on designation and supervision of
Surveillance and monitoring
conformity assessment bodies
1. For the purpose of surveillance, the designating authority
1. Designating
authorities
shall
consult
each
other
and
the
of the Member State where the notified body is established shall
Commission on questions with general relevance with regard to
assess an appropriate number of notified body’s reviews of the
the implementation of this Regulation and the interpretation of
manufacturer’s clinical evaluations and shall carry out an appro
the provisions of Directive 90/385/EEC and of Directive
priate number of file reviews, surveillance on-site assessments
93/42/EEC in relation with conformity assessment bodies.
and observed audits at the following intervals:
(a) at least every 12 months for notified bodies with more than
2. Designating
authorities
shall
communicate
to
each
other
100 clients;
and the Commission by 31 December 2013 the model
assessment check-list used in accordance with Article 3(2) and
thereafter the adaptations made to this check-list.
(b) at least every 18 months for all other notified bodies.
That designating authority shall, in particular, examine changes
3. When
the
assessment
reports
referred
to
in
Article
3(4)
which have occurred since the last assessment and the work the
indicate discrepancies in the general practice of designating
notified body has performed since that assessment.
authorities, Member States or the Commission may request an
exchange of views, which will be organised by the latter.
2. Surveillance
and
monitoring
conducted
by
the
designating
authorities shall appropriately address subsidiaries.
Article 8
3. The
designating
authority
of
the
Member
State
where
the
Operating of designating authorities
notified body is established shall continuously monitor that
1. Designating
authorities
shall
have
a
sufficient
number
of
body to ensure ongoing compliance with the applicable require
competent personnel at their disposal for the proper
ments. That authority shall provide for a systematic follow-up
performance of their tasks. Those authorities shall be estab
of complaints, vigilance reports and other information,
lished, organised and operated so as to safeguard the objectivity
including from other Member States, which might indicate the
and impartiality of their activities and to avoid any conflicts of
non-fulfilment of the obligations by a notified body or its
interests with conformity assessment bodies. The designating
deviation from common or best practice.
authorities shall be organised so that each decision relating to
a notification of a conformity assessment body is not taken by
In addition to surveillance or renewal on-site assessments, the
the same member of personnel who carried out the assessment
designating authority of the Member State where the notified
of that body.

---

L 253/12
EN
Official Journal of the European Union
25.9.2013
2. Where
designating
authorities
are
not
in
charge
of
market body. Member States shall ensure that the accreditation body in
surveillance and vigilance for medical devices, they shall involve
charge of the accreditation of a particular conformity
the competent authorities of that Member State for all tasks
assessment body is kept informed by the designating
incumbent to them in accordance with this Regulation. They
authority of the Member State where the conformity assessment
shall in particular consult the competent authorities of that
body is established on findings relevant for the accreditation.
Member State prior to taking decisions and invite them to
The accreditation body shall inform the designating authority of
attend all types of assessments.
the Member State where the conformity assessment body is
established on its findings.
Article 9
Article 10
Cooperation with accreditation bodies
Where designation is based on accreditation in the meaning of
Entry into force and date of application
Regulation (EC) No 765/2008, Member States shall ensure that
This Regulation shall enter into force on the twentieth day
the accreditation body that has accredited a particular notified
following that of its publication in the Official Journal of the
body is kept informed by the competent authorities on incident
European Union.
reports and other information that relate to matters under the
control of the notified body when the information may be
It shall apply to extension of designations as from 25 December
relevant for the assessment of the performance of the notified
2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 September 2013.
For the Commission
The President
José Manuel BARROSO

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/13
ANNEX I
Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive
93/42/EEC
1. Sections 1 and 5 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted
as including the following elements:
1.1. The conformity assessment body shall be a third-party body that is independent of the manufacturer of the product
in relation to which it performs conformity assessment activities. The conformity assessment body shall also be
independent of any other economic operator having an interest in the product as well as of any competitor of the
manufacturer.
1.2. That conformity assessment body shall be organised and operated so as to safeguard the independence, objectivity
and impartiality of its activities. The conformity assessment body shall have procedures in place that effectively
ensure identification, investigation and resolution of any case in which a conflict of interests may arise, including
involvement of its staff in consultancy services in the field of medical devices prior to taking up employment with
the body.
1.3. That conformity assessment body, its top management and the personnel responsible for carrying out the
conformity assessment tasks shall not:
(a) engage in any activity that may conflict with their independence of judgement or integrity in relation to
conformity assessment activities for which they are notified;
(b) offer or provide any service which may jeopardise the confidence in their independence, impartiality or objec
tivity. In particular, they shall not offer or provide or have offered or provided, during the last three years,
consultancy services to the manufacturer, his authorised representative, a supplier or a commercial competitor as
regards Union requirements for the design, construction, marketing or maintenance of the products or processes
under assessment. This does not preclude conformity assessment activities for manufacturers and economic
operators mentioned above or general training activities relating to medical device regulations or related
standards that are not client specific.
1.4. The conformity assessment body’s top level management and its assessment personnel shall be impartial. The
remuneration of the top level management and assessment personnel of a conformity assessment body shall not
depend on the number or the results of assessments carried out.
1.5. When a conformity assessment body is owned by a public entity or institution, the Member State shall ensure and
document the independence of the conformity assessment body and the absence of any conflict of interests between,
on the one hand, the designating authority and/or competent authority and, on the other hand, the conformity
assessment body.
1.6. The conformity assessment body shall ensure and document that the activities of its subsidiaries or subcontractors,
or of any associated body, do not affect its independence, impartiality or objectivity in its conformity assessment
activities.
1.7. The requirements of points 1.1 to 1.6 do not preclude exchanges of technical information and regulatory guidance
between a body and a manufacturer seeking their conformity assessment.
2. The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the
following elements:
2.1. Subcontracting shall be limited to specific tasks. The subcontracting of the auditing of quality management systems
or of products related reviews in its entirety is not allowed. The conformity assessment body shall in particular keep
internal the review of the qualification and the monitoring of the performance of the external experts, the experts’
assignment to specific conformity assessment activities, and the final review and decision-making functions.

---

L 253/14
EN
Official Journal of the European Union
25.9.2013
2.2. Where a conformity assessment body subcontracts specific tasks or consults external experts related to the
conformity assessment, it shall have a policy describing the conditions under which subcontracting or the consul
tation of external experts may take place. Any subcontracting or consultation of external experts shall be properly
documented and be subject to a written agreement covering, among others, confidentiality and conflict of interests.
2.3. The conformity assessment body shall establish procedures for assessing and monitoring the competence of all
subcontractors and external experts used.
3. Sections 3 and 4 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted
as including the following elements:
3.1. At all times and for each conformity assessment procedure and each kind or category of products in relation to
which it has been or wishes to be notified, a conformity assessment body shall have within its organisation the
following elements:
(a) the necessary administrative, technical, clinical and scientific personnel with technical and scientific knowledge
and sufficient and appropriate experience relating to medical devices and the corresponding technologies to
perform the conformity assessment tasks, including the assessment of clinical data;
(b) a documented process for the conduct of the conformity assessment procedures for which it is designated ( 1 )
taking into account their respective specificities, including legally required consultations, in respect of the
different categories of devices covered by the scope of notification, ensuring transparency and the ability of
reproduction of those procedures.
3.2. The conformity assessment body shall have the necessary personnel and shall possess or have access to all
equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity
assessment activities in relation to which it has been notified.
3.3. The conformity assessment body shall have at its disposal the financial resources required to conduct its conformity
assessment activities and related business operations. It shall document and provide evidence of its financial capacity
and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.
3.4. The conformity assessment body shall have a quality management system in place and operating.
3.5. The experience and knowledge of the personnel responsible for carrying out conformity assessment activities shall be
interpreted as including the following:
(a) sound scientific, technical and vocational training, in particular in the relevant fields of medicine, pharmacy,
engineering or other relevant sciences, covering all the conformity assessment activities in relation to which the
body has been notified or wishes to be notified;
(b) substantial relevant experience covering all the conformity assessment activities in relation to which the body has
been notified or wishes to be notified;
(c) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out
those assessments;
(d) appropriate knowledge and understanding of the relevant provisions of the medical devices legislation and of the
applicable harmonised standards;
(e) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
( 1 ) See Annex II Item 41.

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/15
3.6. The conformity assessment body shall establish and document qualification criteria and procedures for selection and
authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence
required) and the required training (initial and ongoing training). The qualification criteria shall address the various
functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file
review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues
and cells of animal origin, clinical evaluation) covered by the scope of designation.
3.7. The conformity assessment body shall have procedures in place to ensure that its subsidiaries operate on the basis of
the same operating procedures and with the same stringency as its headquarters.
3.8. Where subcontractors or external experts are used in the context of the conformity assessment, in particular
regarding novel, invasive and implantable medical devices or technologies, the conformity assessment body shall
have adequate internal competence in each product area for which it is designated to direct the conformity
assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification.
The internal competence requested shall cover technological, clinical and auditing aspects.
4. Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as
including the following elements:
4.1. The conformity assessment body shall take out appropriate liability insurance corresponding to the conformity
assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certifi
cates, and the geographic scope of its activities, unless liability is assumed by the State under domestic legislation or
the Member State itself carries out the inspections directly.
5. Sections 7 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as
including the following elements:
5.1. The conformity assessment body shall ensure that confidentiality of the information which comes into its possession
during the performance of the conformity assessment activities is observed by its personnel, committees, subsidiaries,
subcontractors or any associated body, except when disclosure is required by law. To this end, it shall have
documented procedures in place.
5.2. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information
obtained in carrying out their tasks, except in relation to the designating authorities and the competent authorities or
the Commission. Proprietary rights shall be protected. To this end, the conformity assessment body shall have
documented procedures in place.

---

L 253/16
EN
Official Journal of the European Union
25.9.2013
ANNEX II
Application form to be submitted when applying for designation as notified body
Designating authority: ....................................................................................
Name of the applying conformity assessment body: ....................................................................................
Previous name (if applicable): ...................................................................................
EU Notified Body number (if applicable): ....................................................................................
Address: ....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
Contact person: ...................................................................................
E-mail: ....................................................................................
Telephone: ...................................................................................
Legal form of the conformity assessment body: ...................................................................................
Company registration number: ....................................................................................
At company register: ...................................................................................
.....................................................................................
.....................................................................................
The following documents shall be added. In case of extension or renewal, only new or modified documents shall be
submitted.
Attachment number
Item/issue
Corresponding
Annex I section
+ Reference
(Section/page)
ORGANISATIONAL AND GENERAL REQUIREMENTS
Legal status and organisational structure
1 Company
statutes
2 Extract
of
company
registration
or
enrolment
act
(Company
register)
3
Documentation on the activities of the organisation to which the
conformity assessment body belongs (if any) and its relationship
with the conformity assessment body
4
Documentation on entities the conformity assessment body owns
(if any), either within the Member State or outside, and the rela
tionship with those entities
5
Description of legal ownership and the legal or natural persons
exercising control of the conformity assessment body
6 Description
of
organisational
structure
and
the
operational
management of the conformity assessment body
7
Descriptions of functions, responsibilities and authorities of top-
level management
8 List
of
all
staff
who
have
an
influence
in
the
conformity
assessment activities
9 Documentation
on
other
services
provided
by
the
conformity
assessment body (if any) (e.g. consultancy relevant to devices,
training etc.)
10 Documentation
on
accreditation(s)
relevant
to
this
application

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/17
Attachment number
Item/issue
Corresponding
Annex I section
+ Reference
(Section/page)
Independence and impartiality
11
Documentation on structures, policies and procedures to safeguard
and promote the principles of impartiality throughout the organi
sation, personnel and assessment activities, including ethical rules
or codes of conduct
12
Description of how the conformity assessment body ensures that
the activities of subsidiaries, subcontractors and external experts do
not affect its independence, impartiality or objectivity
13
Documentation on the impartiality of the top-level management
and personnel involved in conformity assessment activities,
including their remuneration and bonuses
14
Documentation on conflict of interest and resolution of potential
conflict procedure/form
15 Description
of
independence
of
the
conformity
assessment
body
from the designating authority and from the competent authority,
in particular when this body is a public entity/institution
Confidentiality
16 Documentation
on
professional
secrecy
procedure
including
protection of proprietary data
Liability
17
Documentation of the liability insurance, proof that the liability
insurance covers cases where the notified body may be obliged to
withdraw or suspend certificates
Financial resources
18 Documentation
of
the
financial
resources
required
to
conduct
the
conformity assessment activities, related operations, including the
ongoing commitments for certificates issued to demonstrate the
continuing viability of the notified body and consistency with the
range of products certified
Quality system
19
Quality Manual and a list of related documentation on the imple
mentation, maintenance and operation of a quality management
system, including policies for assignment of personnel to activities
and their responsibilities
20 Documentation
on
the
procedure(s)
for
control
of
documents
21 Documentation
on
the
procedure(s)
for
control
of
records
22 Documentation
on
the
procedure(s)
for
management
review
23 Documentation
on
the
procedure(s)
for
internal
audits
24 Documentation
on
the
procedure(s)
for
corrective
and
preventive
actions
25 Documentation
on
the
procedure(s)
for
complaints
and
appeals

---

L 253/18
EN
Official Journal of the European Union
25.9.2013
Attachment number
Item/issue
Corresponding
Annex I section
+ Reference
(Section/page)
Resource requirements
General
26 Description
of
own
laboratories
and
testing
facilities
27 Employment
contracts
and
other
agreements
with
internal
personnel, in particular in relation to impartiality, independence,
conflict of interest (attach a standard contract template)
28 Contracts
and
other
agreements
with
subcontractors
and
external
experts, in particular for impartiality, independence, conflict of
interest (attach a standard contract template)
Qualification and authorisation of personnel
29 List
of
all
permanent
and
temporary
personnel
(technical,
adminis
trative etc.) including information on professional qualification,
past experience and the types of contracts held
30
List of all external personnel (e.g. external experts, external
auditors) including information on professional qualification, past
experience and on the types of contracts held
31 Qualification
matrix
linking
the
body's
staff
and
its
external
experts
to the functions to be accomplished by them and to the fields of
competence for which the body has been notified or wishes to be
notified
32 Qualification
criteria
for
the
different
functions
(see
point
31)
33 Documentation
on
the
procedure(s)
for
selection
and
assignment
of internal or external personnel involved in the conformity
assessment activities, including conditions for the attribution of
tasks to external personnel and the supervision of their expertise
34 Documentation
demonstrating
that
the
management
of
the
conformity assessment body has appropriate knowledge to set
up and operate a system for:
— the selection of the personnel deployed during the conformity
assessment,
— the verification of the knowledge and experience of this
personnel,
— the assignment of the personnel to their tasks,
— the verification of the performance of the personnel,
— the definition and the verification of their initial and ongoing
training
35 Documentation
on
the
procedure
assuring
ongoing
monitoring
of
competences and performance monitoring
36 Documentation
on
standard
training
programmes
conducted
by
the conformity assessment body relevant to the conformity
assessment activities
Subcontractors
37 List
of
all
subcontractors
(not
individual
external
experts)
used
for
conformity assessment activities

---

EN
25.9.2013 Official
Journal
of
the
European
Union L
253/19
Attachment number
Item/issue
Corresponding
Annex I section
+ Reference
(Section/page)
38 Subcontractor
policy
and
procedure
39 Documentation
demonstrating
adequate
core
competence
within
the conformity assessment body to assess, select, contract, and
to verify the appropriateness and validity of subcontractor activities
40 Examples
of
standard
template
contract,
prohibiting
further
subcontracting by legal persons and specifically including
provisions to ensure confidentiality and conflict of interest
management with subcontractors (attach examples)
Process
41 Documentation
on
procedures
relating
to
conformity
assessment
activities and other related documents reflecting the scope of
conformity assessment activities including, in particular procedures
relating to:
— Qualification and classification
— Quality system assessments
— Risk management
— Pre-clinical data evaluation
— Clinical evaluation
— Representative sampling of technical documentation
— Post-market clinical follow up
— Communications from regulatory authorities including
competent authorities and designating authorities
— Communication and analysis of the impact of vigilance reports
on device certification
— Consultation procedures for drug-device combination products,
devices utilising animal tissue, devices utilising human blood
derivatives
— Review and decision making on certificate issuance including
approval responsibilities
— Review and decision making on certificate suspension,
restriction, withdrawal and refusal including approval respon
sibilities
42 Checklists,
templates,
reports
and
certificates
used
for
the
conformity assessment activities
Name and signature of an authorised representative of the applicant
Place and date
conformity assessment body (unless electronic signature is accepted)

---

Document Outline

• �

---