欧盟Eurlex法规详细信息

EURLEX ID:32012R0722

OJ编号:OJ L 212, 9.8.2012, p. 3-12

中文标题:委员会条例(EU) No 722/2012,就由理事会指令90/385/EEC和93/42/EEC规定的主动植入式医疗设备和利用动物源组织制造医疗产品的要求,制定特殊要求(1)

原文标题:Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (1)

分类:13.30.99_统一法的其它部分

文件类型:二级立法 Regulation|条例

生效日期:2012-08-29

废止日期:2058-12-31

法规全文:查看欧盟官方文件

EN
9.8.2012 Official
Journal
of
the
European
Union L
212/3
COMMISSION REGULATION (EU) No 722/2012
of 8 August 2012
concerning particular requirements as regards the requirements laid down in Council Directives
90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices
manufactured utilising tissues of animal origin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Prior
to
being
placed
on
the
market
or
put
into
service,
active implantable medical devices and medical devices of
class III in accordance with the classification rules set out
Having regard to the Treaty on the Functioning of the European
in Annex IX to Directive 93/42/EEC, whether they
Union,
originate in the European Union or are imported from
third countries, are subject to the conformity assessment
procedures laid down in Article 9(1) of Directive
90/385/EEC and in Article 11(1) of Directive 93/42/EEC,
Having regard to Council Directive 90/385/EEC of 20 June
respectively. Annex 1 to Directive 90/385/EEC and
1990 on the approximation of laws of the Member States
Annex I to Directive 93/42/EEC, respectively, set out
relating to active implantable medical devices ( 1 ), and in
the essential requirements that active implantable
particular Article 10c thereof,
medical devices and other medical devices must meet
in this regard.
Having regard to Council Directive 93/42/EEC of 14 June 1993
concerning medical devices ( 2 ), and in particular Article 14b
thereof,
(5) With
regard
to
active
implantable
medical
devices
and
other medical devices manufactured utilising tissues of
animal origin it is necessary to adopt more detailed spec
ifications in relation to the requirements set out in point
Whereas:
6 of Annex 1 to Directive 90/385/EEC and points 8.1
and 8.2 of Annex I to Directive 93/42/EEC. Moreover, it
is appropriate to specify certain aspects relating to the
(1) Specific
rules
for
medical
devices
manufactured
utilising
risk analysis and risk management in the framework of
tissues of animal origin were initially adopted by
the conformity assessment procedures referred to in
Commission Directive 2003/32/EC of 23 April 2003
Article 9 of Directive 90/385/EEC and Article 11 of
introducing detailed specifications as regards the
Directive 93/42/EEC, respectively.
requirements laid down in Council Directive 93/42/EEC
with respect to medical devices manufactured utilising
tissues of animal origin ( 3 ). This Directive was applicable
only to medical devices falling within the scope of
(6) Regulation
(EC)
No
1069/2009
of
the
European
Directive 93/42/EEC.
Parliament and of the Council of 21 October 2009
laying down health rules concerning animal by-
products not intended for human consumption ( 4 ) sets
out provisions on the sourcing of materials used in
(2)
In order to maintain a high level of safety and health
medical devices. It is appropriate to lay down additional
protection against the risk of transmitting animal spon
provisions on the use of such materials as starting tissue
giform encephalopathies to patients or other persons via
for the manufacture of medical devices.
medical devices manufactured utilising non-viable animal

tissues or derivatives rendered non-viable, including
custom-made devices and devices intended for clinical
investigation, it is necessary to update the rules laid
(7) European
and
international
scientific
bodies,
such
as
the
down in Directive 2003/32/EC on the basis of the
European Medicines Agency ( 5 ), the European Food Safety
experience with the application of this Directive and to
Agency ( 6 ), the former Scientific Steering Committee ( 7 )
apply them also to active implantable medical devices
and the former Scientific Committee on Medicinal
manufactured utilising tissues of animal origin that fall
Products and Medical Devices
( 8 ), adopted several
within the scope of Directive 90/385/EEC.
opinions on specified risk materials and on minimising
the risk of transmitting animal spongiform encepha
lopathy agents which are of relevance to the safety of
(3) Taking
into
account
that
this
measure
lays
down
clear
medical devices.
and detailed rules that do not give room for diverging
transposition by Member States, a Regulation is the
( 4 ) OJ L 300, 14.11.2009, p. 1.
appropriate legal instrument which shall replace
( 5 ) Note for guidance on minimising the risk of transmitting animal
Directive 2003/32/EC.
spongiform encephalopathy agents via human and veterinary
medicinal products (EMA/410/01 rev.3) (OJ C 73, 5.3.2011, p. 1).
( 6 ) http://www.efsa.europa.eu/en/topics/topic/bse.htm
( 1 ) OJ L 189, 20.7.1990, p. 17.
( 7 ) http://ec.europa.eu/food/fs/bse/scientific_advice08_en.print.html
( 2 ) OJ L 169, 12.7.1993, p. 1.
( 8 ) See http://ec.europa.eu/health/scientific_committees/emerging/
( 3 ) OJ L 105, 24.4.2003, p. 18.
opinions/scmpmd/index_en.htm

L 212/4
EN
Official Journal of the European Union
9.8.2012
(8) The
Member
States
should
verify
that
the
notified
bodies (a) ‘cell’ means the smallest organised unit of any living form
designated to assess the conformity of medical devices
which is capable of independent existence and of
manufactured utilising animal tissues have the necessary
replacement of its own substance in a suitable environment;
expertise and up-to-date knowledge to perform this task.
(b) ‘tissue’ means an organisation of cells, extra-cellular consti
(9) The
period
for
scrutiny
granted
to
the
competent
auth
tuents or both;
orities of the Member States in relation to the notified
bodies’ summary evaluation report should be shorter for
(c) ‘derivative’ means a material obtained from animal tissue
medical devices manufactured using starting material
through one or more treatments, transformations or steps
which is certified by the European Directorate for the
of processing;
Quality of Medicines than in cases where uncertified
material is used. In both cases, there should be a possi
(d) ‘non-viable’ means having no potential for metabolism or
bility to shorten the standstill period.
multiplication;
(10) To facilitate the smooth transition to the new
(e) ‘TSEs’ means all transmissible spongiform encephalopathies
requirements it is appropriate to provide for an
as defined in Article 3(1)(a) of Regulation (EC) No
adequate transitional period allowing for active
999/2001 of the European Parliament and of the Coun
implantable medical devices already covered by an EC
cil ( 1 );
design-examination certificate or by an EC type exam
ination certificate to continue to be placed on the
(f) ‘TSE infectious agents’ means unclassified pathogenic agents
market and put into service.
which are capable of transmitting TSEs;
(11) The
measures
provided
for
in
this
Regulation
are
in
(g) ‘reduction, elimination or removal’ means a process by
accordance with the opinion of the Committee on
which the number of TSE infectious agents is reduced, elim
Medical Devices set up by Article 6(2) of Directive
inated or removed in order to prevent infection or
90/385/EEC,
pathogenic reaction;
(h) ‘inactivation’ means a process by which the ability to cause
HAS ADOPTED THIS REGULATION:
infection or pathogenic reaction by TSE infectious agents is
reduced;
Article 1
(i) ‘source country’ means the country or countries in which
1. This
Regulation
lays
down
particular
requirements
in
the animal was born, has been reared and/or has been
relation to the placing on the market and/or putting into
slaughtered;
service of medical devices, including active implantable
medical devices, manufactured utilising animal tissue which is
rendered non-viable or non-viable products derived from animal
(j) ‘starting materials’ means raw materials or any other
tissue.
product of animal origin out of which, or with the help
of which, the devices referred to in Article 1(1) are
produced.
2. This
Regulation
shall
apply
to
animal
tissues,
as
well
as
their derivatives, originating from bovine, ovine and caprine
Article 3
species, deer, elk, mink and cats.
1. Before lodging an application for a conformity assessment
pursuant to Article 9(1) of Directive 90/385/EEC or
3. Collagen,
gelatine
and
tallow
used
for
the
manufacturing Article 11(1) of Directive 93/42/EEC, the manufacturer of
of medical devices shall meet at least the requirements as fit for
medical devices referred to in Article 1(1) of this Regulation
human consumption laid down in Regulation (EC) No
or his authorised representative shall carry out the risk
1069/2009.
analysis and risk management scheme set out in Annex I to
this Regulation.
4. This
Regulation
shall
not
apply
to
any
of
the
following:
2. For custom-made devices and devices intended for clinical
(a) Tallow derivatives, processed under conditions at least as
investigation which fall under Article 1(1), the statement of the
vigorous as those laid down in Section 3 of Annex I;
manufacturer or his authorised representative and the documen
tation in accordance with Annex 6 to Directive 90/385/EEC or
Annex VIII to Directive 93/42/EEC, respectively, shall also
(b) medical devices referred to in paragraph 1, which are not
address compliance with the particular requirements set out in
intended to come into contact with the human body or
section 1 of Annex I to this Regulation.
which are intended to come into contact with intact skin
only.
Article 4
1. Member
States
shall
verify
that
bodies
notified
under
Article 2
Article 11 of Directive 90/385/EEC or Article 16 of Directive
For the purposes of this Regulation, the following definitions
93/42/EEC have up-to-date knowledge of the medical devices
apply in addition to the definitions set out in Directive
90/385/EEC and Directive 93/42/EEC:
( 1 ) OJ L 147, 31.5.2001, p. 1.

EN
9.8.2012 Official
Journal
of
the
European
Union L
212/5
referred to in Article 1(1), in order to assess the conformity of
4. Before
issuing
an
EC
design-examination
certificate
or
an
those devices with the provisions of Directive 90/385/EEC or
EC type-examination certificate, the notified bodies shall,
Directive 93/42/EEC, respectively, and with the particular
through their competent authority, hereinafter ‘coordinating
requirements laid down in Annex I to this Regulation.
competent authority’, inform the competent authorities of the
Member States shall regularly verify that those bodies
other Member States and the Commission of their assessment
maintain the required up-to-date knowledge and expertise.
carried out pursuant to paragraph 2 by means of a summary
evaluation report in accordance with Annex II to this Regu
lation.
Where, on the basis of that verification, it is necessary for a
Member State to amend the tasks of a notified body, that
Member State shall notify the Commission and the other
5. The
competent
authorities
of
the
Member
States
may
Member States accordingly.
submit comments on the summary evaluation report referred
to in paragraph 4 within the following deadlines:
2. The
Member
States
shall
inform
the
Commission
and
the
other Member States regarding the outcome of the verification
(a) in relation to medical devices using starting materials for
referred to in the first sentence of paragraph 1 by 28 February
which a TSE certificate of suitability as referred to in
2013.
paragraph 3 has been submitted, within four weeks from
the date on which the notified body informed the coor
Article 5
dinating competent authority pursuant to paragraph 4;
1. Conformity
assessment
procedures
for
medical
devices (b) in relation to medical devices using starting materials for
referred to in Article 1(1) shall include the evaluation of
which a TSE certificate of suitability has not been submitted,
compliance of the devices with the essential requirements of
within 12 weeks from the date on which the notified body
Directive 90/385/EEC or Directive 93/42/EEC, respectively,
informed the coordinating competent authority pursuant to
and the particular requirements laid down in Annex I to this
paragraph 4.
Regulation.
The competent authorities of the Member States and the
2. Notified
bodies
shall
assess
the
documentation
submitted Commission may agree on shortening the time periods set
by the manufacturer to verify that the benefits of the device
out in points (a) and (b).
outweigh the residual risks. Particular account shall be taken of:
6. The
notified
bodies
shall
give
due
consideration
to
any
(a) the manufacturer’s risk analysis and risk management
comments received in accordance with paragraph 5. They
process;
shall convey an explanation as regards this consideration,
including any due justification not to take account of one or
(b) the justification for the use of animal tissues or derivatives,
more of the comments received, and their final decisions to the
taking into consideration lower risk tissues or synthetic
coordinating competent authority, which shall then make these
alternatives;
available to the Commission and the competent authorities
from which comments were received.
(c) the results of elimination and inactivation studies or results
of the analysis of relevant literature;
7. The
manufacturer
shall
collect,
evaluate
and
submit
to
the
notified body information regarding changes with regard to the
animal tissue or derivatives used for the device or with regard to
(d) the manufacturer’s control of the sources of raw materials,
the TSE risk in relation to the device. Where such information
finished products, production process, testing, and subcon
leads to an increase of the overall TSE risk, the provisions of
tractors;
paragraphs 1-6 are applicable.
(e) the need to audit matters related to the sourcing and
Article 6
processing of animal tissues and derivatives, processes to
eliminate or inactivate pathogens, including those activities
Without prejudice to Article 7(2), Member States shall take all
carried out by suppliers.
necessary steps to ensure that medical devices referred to in
Article 1(1) are placed on the market and/or put into service
only if they comply with the provisions of Directive
3. Notified bodies shall, during the evaluation of the risk
90/385/EEC or Directive 93/42/EEC, respectively, and the
analysis and risk management in the framework of the
particular requirements laid down in this Regulation.
conformity assessment procedure, take account of the TSE
certificate of suitability issued by the European Directorate for
the Quality of Medicines, hereinafter ‘TSE certificate of suit
Article 7
ability’, for starting materials, where available.
1. Holders of EC design-examination certificates or EC type-
examination certificates issued before 29 August 2013 for
Where additional information is necessary to assess the suit
active implantable medical devices referred to in Article 1(1)
ability of the starting material for a given medical device,
shall apply to their notified body for a complementary EC
notified bodies may require submission of additional
design-examination certificate or EC type-examination certificate
information to allow the evaluation as set out in paragraphs
attesting compliance with the particular requirements laid down
1 and 2.
in Annex I to this Regulation.

L 212/6
EN
Official Journal of the European Union
9.8.2012
2. Until
29
August
2014,
Member
States
shall
accept
the References to the repealed Directive are to be construed as
placing on the market and the putting into service of active
references to this Regulation.
implantable medical devices referred to in Article 1(1) which are
covered by an EC design-examination certificate or an EC type-
Article 9
examination certificate issued before 29 August 2013.
This Regulation enters into force on the twentieth day following
that of its publication in the Official Journal of the European
Article 8
Union.
Directive 2003/32/EC is repealed with effect from 29 August
It shall apply from 29 August 2013 except for Article 4 which
2013.
shall apply from the date of entry into force of this Regulation.
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 August 2012.
For the Commission
The President
José Manuel BARROSO

EN
9.8.2012 Official
Journal
of
the
European
Union L
212/7
ANNEX I
1.
RISK ANALYSIS AND RISK MANAGEMENT
1.1. Justification
for
the
use
of
animal
tissues
or
derivatives
The manufacturer must justify, on the basis of his overall risk analysis and risk management strategy for a
specific medical device, the decision to use animal tissues or derivatives, referred to in Article 1, (specifying
animal species, tissues and sourcing) taking into account the clinical benefit, potential residual risk and suitable
alternatives (such as lower risk tissues or synthetic alternatives).
1.2. Process
of
risk
assessment
In order to ensure a high level of protection for patients and users, the manufacturer of devices utilising animal
tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis
and risk management strategy, to address all relevant aspects relating to TSE. He must identify the hazards and
evaluate the risks associated with those tissues or derivatives, establish documentation on measures taken to
minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device
utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.
The safety of a device, in terms of its potential for passing on a TSE infectious agent, is dependent on all the
factors described in sections 1.2.1 to 1.2.8, which the manufacturer must analyse, evaluate and manage. These
measures in combination determine the device safety.
At a minimum, the manufacturer must consider the following key steps:
(a) selecting starting materials (tissues or derivatives) considered appropriate regarding their potential contami
nation with TSE infectious agents (see 1.2.1, 1.2.2, 1.2.3 and 1.2.4) taking into account further collection,
handling, transport, storage and processing;
(b) applying a production process to remove or inactivate TSE infectious agents on controlled sourced tissues or
derivatives (see 1.2.5);
(c) maintaining a system to collect and evaluate production and post-production information regarding changes
which may affect the assessment of the suitability of steps referred to in points (a) and (b).
Furthermore, the manufacturer must take into account the characteristics of the device and its intended use (see
1.2.6, 1.2.7 and 1.2.8).
In performing the risk analysis and risk management strategy, the manufacturer must give due consideration to
the relevant published opinions adopted by the relevant European or international scientific committees or
bodies, such as the Scientific Steering Committee (SSC), the European Food Safety Agency (EFSA), the
European Medicines Agency (EMA), the World Organisation for Animal Health (OIE) and the World Health
Organisation (WHO).
1.2.1. Animals
as
a
source
of
material
The TSE risk is related to the source species, strains and nature of the starting tissue. As the accumulation of TSE
infectivity occurs over an incubation period of several years, sourcing from young healthy animals is considered
to be a factor reducing the risk. Risk animals such as fallen stock, emergency slaughtered and TSE suspected
animals must be excluded as a source of material.
1.2.2. Geographical
sourcing
When assessing the risk of the source country, Commission Decision 2007/453/EC of 29 June 2007 establishing
the BSE status of Member States or third countries or regions thereof according to their BSE risk ( 1 ) is to be taken
into account.
1.2.3. Nature
of
starting
tissue
The manufacturer must take into account the classification of the risks relating to different types of starting tissue
as defined in the WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform
( 1 ) OJ L 172, 30.6.2007, p. 84.

L 212/8
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Official Journal of the European Union
9.8.2012
Encephalopathies (2006), as amended. Sourcing of animal tissue must be performed in such a manner as to
maintain control over the traceability and integrity of source tissue. Where appropriate, the animals shall be
subjected to veterinary ante- and post-mortem inspection.
In addition, Regulation (EC) No 1069/2009 applies.
Without prejudice to the provision in the following paragraph, only category 3 material in accordance with
Article 10 of Regulation (EC) No 1069/2009 shall be used.
The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infective, unless
sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit
for the patient and the absence of an alternative starting tissue.
For bovine, ovine and caprine animals, the list of specified risk material (SRM) laid down in Annex V to
Regulation (EC) No 999/2001 is to be considered as being potentially of high TSE infectivity.
1.2.4. Slaughtering
and
processing
controls
to
prevent
cross
contamination
The manufacturer must ensure that the risk of cross-contamination during slaughtering, collection, processing,
handling, storage and transport is minimised.
1.2.5. Inactivation
or
removal
of
TSE
infectious
agents
1.2.5.1. For devices which cannot withstand an inactivation or elimination process without undergoing unacceptable
degradation, the manufacturer must rely principally on the control of sourcing.
1.2.5.2. For other devices, if claims are made by the manufacturer for the ability of manufacturing processes to remove
or inactivate TSE infectious agents, these must be substantiated by appropriate documentation.
Relevant information from an analysis of appropriate scientific literature can be used to support inactivation and
elimination factors, where the specific processes referred to in the literature are comparable to those used for the
device. This search and analysis shall also cover the available scientific opinions that may have been adopted by
an European or international scientific committee or body. These opinions are to serve as a reference, in cases
where there are conflicting opinions.
If the literature search fails to substantiate the claims, the manufacturer must set up a specific inactivation or
elimination study, as appropriate, on a scientific basis and the following need to be considered:
(a) the identified hazard associated with the tissue;
(b) identification of the relevant model agents;
(c) rationale for the choice of the particular combinations of model agents;
(d) identification of step and/or stage chosen to eliminate or inactivate the TSE infectious agents;
(e) documentation of the parameters for any TSE inactivation or elimination validation study;
(f) calculation of the reduction factors.
The manufacturer must apply appropriate documented procedures to ensure that the validated processing
parameters are applied during routine manufacture.
A final report must identify manufacturing parameters and limits that are critical to the effectiveness of the
inactivation or elimination process.
1.2.6. Quantities of animal tissues or derivatives required to produce one unit of the medical device
The manufacturer must evaluate the quantity of raw tissues or derivatives of animal origin required to produce a
single unit of the medical device. The manufacturer must assess whether the production process has the potential
to concentrate levels of TSE infectious agents present in the animal starting tissues or derivatives.

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Union L
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1.2.7. Tissues
or
derivatives
of
animal
origin
coming
into
contact
with
the
patients
and
users
The manufacturer must consider:
(a) the maximum quantity of animal tissues or derivatives coming into contact with the patient or user when
using a single medical device;
(b) the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);
(c) the type of the tissues or derivatives coming into contact with the patients or users;
(d) the period of time the device is intended to remain in contact with the body (including bioresorption effect);
and
(e) the number of medical devices that could be used in a given procedure or, if possible, over the lifetime of a
patient or user.
1.2.8. Route
of
administration
In the risk assessment, the manufacturer must take into account the route of administration as indicated in the
product information.
1.3. Review
of
the
risk
assessment
The manufacturer must establish and maintain a systematic procedure to review information gained about the
medical device or similar devices in the post-production phase. The information must be evaluated for possible
relevance to safety, especially in any of the following cases:
(a) previously unrecognised hazards are identified;
(b) the estimated risk arising from a hazard has changed or is no longer acceptable;
(c) the original assessment is otherwise invalidated.
In the cases set out in points (a), (b) or (c), the manufacturer shall feed back the results of the evaluation as an
input to the risk management process.
In the light of this new information, a review of the appropriate risk management measures for the device must
be considered (including rationale for choosing an animal tissue or derivative). If there is a potential that the
residual risk or its acceptability has changed, the impact on previously implemented risk control measures must
be re-evaluated and justified.
The results of this evaluation must be documented.
2. EVALUATION
BY
NOTIFIED
BODIES
For the medical devices referred to in Article 1(1), manufacturers must provide to the notified bodies referred to
in Article 4 all relevant information to allow evaluation of their risk analysis and risk management strategy in
accordance with Article 5(2).
2.1. Information
of
the
Notified
Body
regarding
changes
and
new
information
Any change in relation to processes of sourcing, collection, handling, processing and inactivation or elimination
and any new information on TSE risk collected by the manufacturer and relevant for the medical device that
could modify the result of the manufacturer’s risk assessment must be transmitted to the notified body and,
where applicable, needs to be approved by the notified body prior to its implementation.
2.2. Renewal
of
certificates
In the context of its decision regarding the extension for a further period of maximum five years of an EC
design-examination certificate or an EC type-examination certificate in accordance with Article 9(8) of Directive
90/385/EEC or Article 11(11) of Directive 93/42/EEC, respectively, the notified body shall review for the purpose
of this Regulation at least the following aspects:

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Official Journal of the European Union
9.8.2012
(a) updated justification for the use of animal tissue or derivative, including a comparison with lower risk tissues
or synthetic alternatives;
(b) updated risk analysis;
(c) updated clinical evaluation;
(d) updated test data and/or rationales, for example in relation to the current harmonised standards;
(e) identification of any changes made since the issue of the original certificate (or last renewal) that could
impact the TSE risk;
(f) evidence that the design dossier remains state of the art in relation to TSE risks.
2.3. Increase
of
the
overall
TSE
risk
Where on the basis of information submitted in accordance with section 2.1 or 2.2 a notified body establishes
that the overall TSE risk in relation to a medical device is increased, this notified body shall follow the procedure
set out in Article 5.
3.
RIGOROUS PROCESSES FOR TALLOW DERIVATIVES AS REFERRED TO IN ARTICLE 1, PARAGRAPH 4, OF
THIS REGULATION
— Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure
(glycerol, fatty acids and fatty acid esters production),
— Saponification with NaOH 12 M (glycerol and soap production)
— Batch process: at not less than 95 °C for not less than 3 hours,
— Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent,
— Distillation at 200 °C.

EN
9.8.2012 Official
Journal
of
the
European
Union L
212/11
ANNEX II
Summary Evaluation Report in accordance with Article 5(4) of Regulation (EU) No 722/2012
Details relating to the submitting notified body
1. Name of notified body 2.
Notified
body
number 3.
Country
4. Sent by 5.
Contact
person 6.
Telephone
7. Fax 8.
E-mail 9.
Client
reference
(name
of
manu
facturer and, if applicable, of auth
orised representative)
10. Confirmation that, in accordance with Article 11 of Directive 90/385/EEC and Article 16 of Directive 93/42/EEC,
respectively, and Article 4 of Regulation (EU) No 722/2012, the submitting notified body has been designated by its
competent authority for the conformity assessment of
active implantable medical devices manufactured utilising tissues of animal origin subject to Regulation (EU)
No 722/2012,
medical devices manufactured utilising tissues of animal origin subject to Regulation (EU) No 722/2012
Data relating to the (active implantable) medical device
11. (a) Active implantable medical device
Other medical device
11. (b) Product description and composition
12. Information on intended use
13. Starting material
13. (a) EDQM certificate available
YES NO
(If the EDQM certificate is available, it must be submitted with this summary evaluation report.)
13. (b) Information regarding
— the nature of the starting tissue(s):
— animal species(s):
— geographical source(s):
14. A description of the key elements adopted to minimise the risk of infection:
15. An estimate of the TSE risk arising from the use of the product, taking into account the likelihood of contami
nation of the product, the nature and duration of patient exposure:
16. A justification for the use of animal tissues or derivatives in the medical device, including a rationale for the
acceptability of the overall TSE risk estimate, the evaluation of alternative materials and the expected clinical
benefit:
17. The approach to the auditing of source establishments and suppliers for the animal material used by the device
manufacturer:

L 212/12
EN
Official Journal of the European Union
9.8.2012
Notified Body Statement
18. Conclusion of this assessment:
Based on the evaluation of data and the assessment process it is our preliminary decision that the application
meets the requirements of conformity with
Council Directive 90/385/EEC
Council Directive 93/42/EEC
and Regulation (EU) No 722/2012.
Date of submission
19. This report was sent on ........................................................................ to the Coordinating Competent Authority of
......................................................................... to inform the Competent Authorities of the other Member States and
the Commission and to seek their comments, if any.

Document Outline


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