EN    EN  
 EUROPEAN COMMISSION   
Brussels, XXX  
[…](2011)  
  
COMMISSION REGULATION (EU) No …/..  
of XXX  
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)  
  
EN 1   EN COMMISSION REGULATION (EU) No …/..  
of XXX  
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 utilisi ng tissues of animal origin  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of 
laws of the Member St ates relating to active implantable medical devices1, and in particular 
Article 10c thereof,  
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices2, 
and in particular Article 14b thereof,  
Whereas:    
(1) Specific rules for medi cal devices manufactured utilising tissues of animal origin were 
initially adopted  by Commission Directive 2003/32/EC of 23 April 2003 introducing 
detailed specifications as regards the requirements laid down in Council Directive 
93/42/EEC with respect to medical devices manufactured utilising tissues of animal 
origin3. This Directive was applicable only to medical devices falling within the scope 
of Directive 93/42/EEC.   
(2) In order to maintain a high level of safety and health protection against the risk of  
transmitting animal spongiform encep halopathies to patients or other persons via 
medical devices manufactured utilising non -viable animal tissues or derivatives 
rendered non -viable,  including custom -made devices and devices intended for clinical 
investiga tion, it is necessary to update the rules daid down in Directive 2003/32/EC on 
the basis of the experience with the application of this Directive  and to apply them 
also to active implantable medical devices manufactured utilising tissues of animal 
origin  that fall within the scope of Directive 90/385/EEC.  
                                                
1 OJ L 189, 20.7.1990, p. 17.  
2 OJ L 169, 12.7.1993, p. 1.  
3 OJ L 105, 24.4.2003, p. 18.   
EN 2   EN (3) Taking into account that this measure lays down clear and detailed rules that do not 
give room for diverging transposition by Member States, a Regulation is the 
appropriate legal instrument which shall rep lace Directive 2003/32/EC.  
(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 in Annex IX to that Directive , whether they originat e 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, respectively. Annex 1 to Directive 90/385/EEC a nd Annex I to Directive 
93/42/EEC , respectively, set out the essential requirements that active implantable 
medical devices and other medical devices must meet  in this regard.  
(5) With regard to  active implantable medical devices and other medical devices 
manu factured utilising tissues of animal origin it is necessary to adopt more detailed 
specifications in relation to the requirements set out in point 6 of Annex 1 to Directive 
90/385/EEC and p oints 8.1 and 8.2 of Annex I to Directive 93/42/EEC . Moreover, it i s 
appropriate to specify certain aspects relating to the risk analysis and risk management 
in the framework of the conformity assessment procedures referred to in Article 9 of 
Directive 90/385/EEC and Article 11 of Directive  93/42/EEC, respectively.  
(6) Regula tion (EC) No 1069/2009 of the European Parliament and of the Council of 21 
October 2009 laying down health rules concerning animal by -products not intended 
for human consumption4 sets out provisions on the sourcing of materials used in 
medical devices. It is appropriate to lay down  additional provisions on the use of such 
materials as starting tissue  for the manufacture of medical devices.  
(7) European and international s cientific bodies, such as the European Medicines 
Agency5, the European Food Safety Agency6, the former Scientific Steering 
Committee7 and the former Scientific Committee on Medicinal Products and Medical 
Devices8, adopted several opinions on specified risk materials and on minimising the 
risk of transmitting animal spongiform encephalopathy agen ts which are of relevance 
to the safety of medical devices.   
(8) The Member States should verify that the notified bodies designated to asse ss the 
conformity of medical devices manufactured utilising animal tissues have the 
necessary expertise  and up -to-date k nowledge to perform this task.     
(9) The period for scrutiny granted to  the competent authorities of the Member States in 
relation to the notified bodies' summary evaluation report should be shorter for 
medical devices manufactured using starting material whi ch is certified by the 
European Directorate for the Quality of Medicines than in cases where uncertified 
material is used. In both cases, there should be a possibility to shorten the standstill 
period.   
                                                
4 OJ L 300, 14. 11.2009, p.1.  
5 Note for guidance on minimising the risk of transmitting animal 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.  
7 http://ec.europa.eu/food/fs/bse/scientific_advice08_en.print.html.  
8 See http://ec.europa.eu/health/scientific_committees/emerging/opinions/scmpmd/index_en.htm .  
EN 3   EN (10) To facilitate the smooth transition to the new requir ements i t is appropriate  to provide 
for an adequate transitional period allowing for active implantable medical devices 
already covered by an EC design -examination certificate or by an EC type 
examination certificate  to continue to be placed on the market and put into service .    
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee on Medical Devices set up by Article 6(2) of Directive 90/385/EEC , 
HAS ADOPTED THIS REGULATION:  
Article 1     
1. This Regulation lays d own particular requirements  in relation to the placing on the market 
and/or putting into 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 tissue.  
2. This Regulation shall apply to  animal tissues , as well as their derivatives , originating from 
bovine, ovine and caprine species, deer, elk, mink and cats .  
3. Collagen, gelatine and tallow used for the manufacturing of medical de vices sh all meet at 
least the requirements as fit for human consumption  laid down in Regulation (EC) No 
1069/2009 . 
4. This Regulation shall not apply to any of the following:  
(a) Tallow derivatives, processed under conditions at least as vigorous as those laid down in 
Section 3 of Annex I ;  
(b) medical devices referred to in paragraph 1, which are not intended to come into contact 
with the human body or which are intended to come into contact with intact skin only.  
Article 2  
For the purposes of this Regulat ion, the following definitions apply in addition to the 
definitions set out in Directive 90/385/EEC and Directive 93/42/EEC:  
(a) ‘cell’ means the smallest organised unit of any living form which is capable of 
independent existence and of replacement of its own  substance in a suitable 
environment;  
(b) ‘tissue’ means an organisation of cells, extra -cellular constituents or both;  
(c) ‘derivative’ means a material obtained from animal tissue through one or more 
treatments, transformations or steps of processing;  
(d) ‘non-viabl e’ means having no potential for metabolism or multiplication;   
EN 4   EN (e) ‘TSEs ’ means all transmissible spongiform encephalopathies as defined in 
Article 3(1)(a) of Regulation (EC) No 999/2001  of the European Parliament 
and of the Council9; 
(f) ‘TSE infectious agents ’ means unclassified pathogenic agents which are 
capable  of transmitting TSEs ;  
(g) ‘reduction, elimination or removal’ means a process by which the number of 
TSE infectious agents is reduced, eliminated or removed in order to prevent 
infection or pathogenic reac tion; 
(h) ‘inactivation’ means a process by which the ability to cause infection or 
pathogenic reaction by TSE infectious agents is reduced;  
(i) ‘source country’ means the country or countries in which the animal was born, 
has been reared and/or has been slaughter ed; 
(j) ‘starting materials’ means raw materials or any other product of animal origin 
out of which, or with the help of which, the devices referred to in Article 1(1) 
are produced.    
Article 3  
1. Before lodging an application for a conformity assessment pursu ant to Article 9(1) of 
Directive 90/385/EEC or Article 11(1) of Directive 93/42/EEC, the manufacturer of medical 
devices referred to in Article 1(1)  of this Regulation  or his authorised representative  shall 
carry out the risk analysis and the risk manageme nt scheme set out in Annex I to this 
Regulation.  
2. For custom -made devices and devices intended for clinical investigation  which fall under 
Article 1(1), the statement of the manufacturer or his authorised representative and the 
documentation in accordanc e with Annex 6 to Directive 90/385/EEC or Annex VIII to 
Directive 93/42/EEC, respectively, shall also address compliance with the particular 
requirements set out in section 1 of Annex I to this Regulation.  
Article 4  
1. Member States shall verify that bodie s notified under Article 11 of Directive 90/385/EEC 
or Article 16 of Directive 93/42/EEC have up -to-date knowledge of the medical devices 
referred to in Article 1(1), in order to assess the conformity of those devices with the 
provisions of Directive 90/38 5/EEC or Directive 93/42/EEC , respectively , and with the 
particular requirements laid down in Annex I to this Regulation. Member States shall 
regularly verify that those bodies maintain the required up -to-date knowledge and expertise.  
Where , on the basis o f 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 Member 
States accordingly.  
                                                
9 OJ L 147, 31.5.2001, p. 1.   
EN 5   EN 2. The Member States shall inform the Commission and the other Member Stat es regarding 
the outcome of the verification referred to in the first sentence of paragraph 1 by…[insert 
date: 6 months after entry into force of this Regulation ]. 
Article 5  
1. Conformity assessment procedures for medical devices referred to in Article 1(1 ) shall  
include the evaluation of compliance of the devices with the essential requirements of 
Directive 90/385/EEC or Directive 93/42/EEC , respectively , and the particular requirements 
laid down in Annex I to this Regulation . 
2. Notified bodies shall assess the documentation submitted by the manufacturer  to verify  that 
the benefits of the device outweigh the residual risks . Particular account shall be taken of : 
(a) the manufacturer's risk analysis and risk management  process ; 
(b) the justification for the use of a nimal tissues or derivatives , taking into 
consideration  lower risk tissues or synthetic alternatives ; 
(c) the results of elimination and inactivation studies  or results  of the analysis of 
relevant literature;  
(d) the manufacturer's control of the sources of raw ma terials, finished products, 
production process, testing,  and subcontractors;  
(e) the need to audit matters related to the sourcing and processing of animal 
tissues and derivat ives, processes to eliminate  or inactivate pathogens , 
including those activities carried out by suppliers.   
3. Notified bodies shall, during the evaluation of the risk analysis and risk management in the 
framework of the conformity assessment procedure, take account of the TSE certificate of 
suitability issued by the European Directorate f or the Quality of Medicines, hereinafter ‘TSE 
certificate  of suitability ’, for starting materials, where available.  
Where  additional information is necessary to assess the suitability of the starting materi al for 
a given medical device, notified b odies may  require submission of additional information to 
allow the evaluation as set out in paragraph s 1 and 2 . 
4. Before issuing an EC design -examination certificate or an EC type -examination certificate, 
the notified bodies shall, through  their competent authori ty, hereinafter 'coordinating 
competent authority', inform the competent authorities of the other Member States and the 
Commission of their assessment carried out pursuant to paragraph 2 by means of a summary 
evaluation report in accordance with Annex II  to this Regulation . 
5. The competent authorities of the Member States may submit comments on the summary 
evaluation report referred to in paragraph 4  within the following deadlines:  
(a) in relation to  medical devices using starting materials for which a TSE  certificate of 
suitability as referred to in paragraph 3 has been submitted, within four weeks from the date 
on which the notified body informed the coordinating competent authority  pursuant to 
paragraph  4;    
EN 6   EN (b) in relation to medical devices using start ing materials for which a TSE certificate of 
suitability has not been submitted, within twelve weeks from the date on which the notified 
body informed the coordinating competent authority pursuant to paragraph  4. 
The competent authorities of the Member Sta tes and the Commission may agree on  
shorten ing the time period s set out in points (a) and (b). 
6. The notified bodies shall give due consideration to any comments received in accordance 
with paragraph 5. They shall convey  an explanation as regards this con sideration , including  
any due justification not to take account of one or more of the comments  received, and their 
final decisions to the coordinating  competent authority, which shall then make these available 
to the Commission and the competent authoritie s from which comments were received.  
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  the TSE risk in relation to  the device. Where such information leads to an increase 
of the overall TSE risk, the provisions of paragraphs 1 -6 are applicable.  
Article 6  
Without prejudice to Article 7 (2), Member States shall take all necessary steps to ensure that 
medical devices refe rred to in Article 1(1) are placed on the market and/or put into service 
only if they comply with the provisions of Directive 90/385/EEC or Directive 93/42/EEC , 
respectively , and the particular requirements laid down in this Regulation.    
Article 7  
1. Hold ers of EC design -examination certificates or EC type -examination certificates issued 
before [insert date: 12 m onths after entry into force of this Regulation ] for active implantable 
medical devices  referred to in Article 1(1) shall apply to their notified body for a 
complementary EC design -examination certificate or EC type -examination certificate 
attesting compliance with the particular requirements  laid down in Annex  I to this Regulation . 
2. Until [insert date:  24 months after entry into force of this Reg ulation ], Member States shall 
accept the placing on the market and the putting into service of active implantable medical 
devices  referred to in Article 1(1) which are covered by an EC design -examination certificate 
or an EC type -examination certificate is sued before [insert date: 12 months after entry into 
force of this Regulation ]. 
Article 8  
Directive 2003/32/EC is repealed with effect from [insert date: 12 months after entry into 
force of this Regulation].   
References to the repealed Directive are to be construed as references to this Regulation.   
EN 7   EN Article 9 
This Regulation enters into force on the twentieth day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from [insert date: 12 months after entry into force  of this Regulation] except for 
Article 4 which 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,  
 For the Commission  
 The Preside nt  
EN 8   EN 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 us e 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 a nd 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 th e following key steps:  
(a) selecting starting materials (tissues or derivatives) considered appropriate regarding 
their potential contamination with TSE infectious agents (see 1.2.1, 1.2.2, 1.2.3 and 
1.2.4) taking into account further collection, handling, tra nsport, 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 re garding 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 perf orming 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 Commit tee 
(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').   
EN 9   EN 1.2.1.  Animals as a source of material  
The TSE risk is related to the source sp ecies, 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 stoc k, 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 
establishing the BSE status of Member States or third countrie s or regions thereof according 
to their BSE risk10 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 Guidelin es on Tissue Infectivity Distribution in 
Transmissible Spongiform 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 appropria te, 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 infectiv e, unless sourcing of these materials is necessary in exceptional circumstances, 
taking into account the imp ortant 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 potentiall y 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.  
                                                
10 OJ L 172, 30.6.2007, p. 84.   
EN 10   EN 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 cla ims 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 b een adopted by a n 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 s pecific 
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 particu lar 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 factor s. 
The manufacturer must apply a ppropriate 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 
effectiven ess 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.   
EN 11   EN 1.2.7.  Tissues or derivatives of animal origin c oming 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 bioresorpti on 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 administrati on 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 
informa tion 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 o therwise 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 manageme nt 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 mus t 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 i nformation to allow evaluation of their risk 
analysis and risk management strategy in accordance with Article 5(2).   
EN 12   EN 2.1. Information of the Notified Body regarding changes and new information  
Any change in relation to processes of sourcing, collection, handlin g, 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 certificat e 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:  
(a) update d 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 cu rrent 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 sections 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 i n Article 5.   
3. RIGOROUS  PROCESSES  FOR  TALLOW  DERIVATIVES  AS REFERRED  
TO IN ARTICLE  1, PARAPRAPH  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,  
– Distilla tion at 200°C.   
EN 13   EN ANNEX II  
SUMMARY EVALUATION REPORT IN ACCORDANCE WITH ARTICLE 5(4) OF REGULATION  (EU)  
NO …/…  
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 manufacturer and, if 
applicable, of authorised 
representative)  
 
10. Confirmation that , in accordance with Article 11 of Directive 90/385/EEC and Article 16 of 
Directive 93/42/EEC, respectivel y, and Article 4 of Regulation  (EU) No …/… ., 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 …/… .,  
  medical devices manufactured utilising tissues of animal origin subject to 
Regulation  (EU) No …/…  . 
Data relating to the (active imp lantable) medical device  
11. a)   Active implantable medical device   Other medical device  
11. b) Product description and composition   
 
12. Information on intended use  
  
EN 14   EN 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 n ature of the starting tissue(s) : 
– animal species(s) : 
– geographical source(s) : 
14. A desc ription of the key elements adopted to minimise th e risk of infection:  
 
15. A n estimate of the TSE risk arising from the use of the product, taking into account the 
likelihood of contamination of the product, t he nature and duration of patient exposure : 
 
16. A  justification for the use of animal tissue s 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. T he approach to the auditing of source establishments and suppliers for the animal material 
used by the device manufacturer:  
 
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 requi rements of conformity with  
  Council Directive 90/385/EEC   Council Directive 93/42/EEC  
and Regulation  (EU) No …/… ..  
 
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.   
EN 15   EN