Medical Device       
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MDCG 2020-12 
  
         Guidance on transition al provisions for 
       consultations of authorities on devices 
       incorporating a substance which may be 
       considered a medicinal product and which  
       has action ancillary to that of the device,  
       as well as on devices manufactured using  
       TSE suscep tible animal tissues   
             
 
           June 2020 
 
 
  
 
This document has been endorsed by the Medical Device Coordination Group 
(MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. 
  Medical Device       
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Guidance on transitional provisions for consultations of author ities on 
devices incorporating a substa nce which may be considered a 
medicinal product and which has action ancillary to that of the  device, 
as well as on devices manufacture d using TSE susceptible animal  
tissues 
 
I. Consultations for a substance which may be considered a medicin al product 
and which has action ancillary to that of the device (including  human blood 
derivatives) 
 
Consultation procedure under the MDD and AIMDD 
According to Annex I section 7.4 of Directive 93/42/EEC on medical devices (the MDD), and Annex 
I section 10 of Directive 90/385/EEC on active im plantable medical devices (the AIMDD), for 
devices containing a substance which, if used separately, would be considered to be a medicinal 
product and which is liable to act upon the body with an action ancillary to that of the device, the 
notified body is required, having verified the usefulness of the substance as part of the medical device 
and taking account of the intended purpose of the device, to seek a scientific opinion from one of the competent authorities designated by the Member St ates or the European Medicines Agency (EMA) on 
the quality and safety of the  substance in the medical device, including the clinical benefit/risk profile 
of the incorporation of the substance into the device. Similarly, where changes are made to that 
substance, particularly relating to its manufacturing process, the notified body is required to consult 
with the same authority in order to confirm that the quality and safety of that substance are maintained 
and to ensure that the changes have no negative impact on the established benefit/risk profile of the 
addition of the substance in the medical device. This consultation on changes is referred to as supplementary consultation in this guidance document.  
 
There is an equivalent consultation requirement for medical devices containing a human blood 
derivative with ancillary action. In this case the notified body is required to consult the EMA only. 
 
Transitioning from MDD and AIMDD to MDR 
 
Regulation (EU) 2017/745 on medical devices (the MDR)  establishes a similar requirement in Article 
52 (9) (Annex IX section 5.2 and Annex X Section 6): fo r devices incorporating, as an integral part, a 
substance which, if used separately, may be considered to be a medicinal product
1 and which has an 
action ancillary to that of the device (hereafter referred to in this document as the ancillary substance), 
the notified body is required, having verified the usefulness of the substance as part of the medical 
device and taking account of the intended purpose of the device, to consult a medicinal products 
authority designated by a Member State or the EMA2 on the quality and safety of the substance, 
including the benefit or risk of the incorporation of the substance into the device. The notified body is 
                                                           
1 including a medicinal product derived from human blood or human plasma 
2 only the EMA in the case of medicinal products derived from human blood or human plasma, or those falling 
exclusively within the scope of Regulation (EC) 726/2004  Medical Device       
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 required to do so both for the initial conformity assessment of the device (this consultation is referred 
to as initial in this guidance document) and for an y subsequent changes to the ancillary substance, in 
particular in relation to its manufacturing process (the consultation on changes is referred to as a 
supplementary consultation, by analogy to the M DD/AIMDD). A competent auth ority designated by a 
Member State in accordance with Directive 2001/83/EC or the EMA (hereafter referred as medicinal products authority in this document) consulted has 210 days since the receipt of all the necessary 
documentation to provide its opinion in the case of an initial consultation, or 60 days for a 
supplementary consultation. Unlike the MDD and AIMDD, the MDR also states that the notified 
body may not deliver the certificate if the opinion is unfavourable (Annex IX 5.2 (e) and (f)).  
 This document provides guidance on fulfilling th is requirement for the first time under the MDR for 
devices which already underwent a consultation with a medicinal products authority according to 
Annex I 7.4 of the MDD or Annex I 10 of the AIMDD. 
 
Consultation for ancillary substances under the MDR for devices which have undergone the 
consultation under the MDD or AIMDD 
 
In order for the notified body to issue the first certificate for a given device under the MDR, a full 
conformity assessment covering all requirements has to be carried out even if the device has been 
certified under the MDD (Q&A IV.1 MDCG 2019-6). For devices containing ancillary substances, this includes the consultation of the medicinal products authority as per Article 52 (9) of the MDR.  
 
For some devices, there may be no change to the device, the ancillary substance and its manufacturing 
process since the last consultation of the me dicinal products authority  under the MDD/AIMDD. 
Nevertheless, there may be changes in the documentation of the device due to the new requirements 
of the MDR, for example in clinical evaluation, which have a bearing on the quality, safety or 
usefulness of the ancillary substance. There may also be changes in the assessment of the device and its documentation by the notified body under the MDR. Lastly, the medicinal products authority may 
have new information on the substance, leading to a modified or different opinion.   
 
For the first consultation under the MDR, the notified body is required to submit the full 
documentation package to the medicinal products authority as described in dedicated guidance. The notified body is free to approach any medicinal products authority at its discretion, not necessarily the 
one consulted under the MDD/AIMDD. This should in clude the last opinion of the medicinal products 
authority under the MDD/AIMDD (whether initial or supplementary), as well as a consolidated list of 
changes, if any, in the following:  
 the ancillary substance, 
 its manufacturing process,   
 the way the substance is incorporated into the device, 
 design, manufacturing of the device which could influence the quality, safety or usefulness of 
the ancillary substance, and/or 
 the parts of the technical documentation related to the above aspects.  
If there were no changes to some or any of the above, the package may be accompanied by a 
declaration by the notified body to this effect, stating the elements that have remained identical. If 
there have also been no changes to the assessment of this documentation by the notified body, this 
may be included in the declaration. Should there be only administrative changes to the above (e.g. 
changes of names or addresses, changes in document layout, etc.), these should be clearly detailed in the declaration.  
 
The medicinal products authority may consider the depth of its review given the extent of the changes 
since the previous consultation under the MDD/AIMDD. It is at the discretion of the medicinal Medical Device       
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 products authority to issue its opinion in less than 210 days. If many elements concerning the 
substance remain identical, the medicinal products authority is highly recommended to expedite its 
review.   
 
The medicinal products authority may contact the authority consulted on this device under the MDD/AIMDD, who may, at its discretion, confirm the opinion provided in the previous consultation 
and/or share any additional information. The final opinion for the consultation under the MDR and its 
issuance according to the stipulated timeline remains the responsibility of the medicinal products 
authority to which the notified body submitted the request under the MDR.  
  
Note on “liability to act upon the body”  
 
It should be noted that Annex I 7.4 of the MDD refers to devices in which the substance is liable to 
act upon the body . In the MDR (Article 52(9), referring to Article 1(8), and Section 5.2 of Annex 
IX), this is no longer the case. Therefore, for al l those devices where the "liability to act upon the 
body" was used by the manufacturer as a justification not to follow the consultation, the consultation 
must take place under the MDR.  In those cases where there are doubts on the applicability of the 
consultation, independently of any considerations concerning the classification of the device, the 
notified body should seek the scientific opinion as described in Annex IX Section 5.2 (b) of the MDR.    
Relevant text from MDD and MDR  
MDD – Annex I Section 7.4 [emphasis added] 
Where a device incorporates, as an integral part, a substance which, if used separately, may be 
considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is 
liable to act upon the body  with action ancillary to that of the device, the quality, safety and 
usefulness of the substance must be verified by an alogy with the methods specified in Annex I to 
Directive 2001/83/EC. 
 
For the substances referred to in the first paragraph, t he notified body shall, having verified the 
usefulness of the substance  as part of the medical device and taking account of the intended purpose 
of the device, seek a scientific opinion from one of the competent authorities designated by the 
Member States or the European Medicines Agency (EMEA)  acting particularly through its 
committee in accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the 
substance including the clinical benefit/risk profile of the incorporation of the substance into the 
device . When issuing its opinion, the competent authority or the EMEA shall take into account the 
manufacturing process and the data related to the usefulness  of incorporation of the substance into 
the device as determined by the notified body. 
 
Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, 
having verified the usefulness of the substance  as part of the medical device and taking into account 
the intended purpose of the device, seek a scientific opinion from the EMEA , acting particularly 
through its committee, on the quality and safety of the substance including the clinical benefit/risk 
profile of the incorporation of the human blood derivative into the device . When issuing its opinion, 
the EMEA shall take into account the manufacturing process and the data related to the usefulness of 
incorporation of the substance into the device as determined by the notified body. 
Where changes are made to an ancillary substance incorporated in a device, in particular related to 
its manufacturing process, the notified body shall be informed of the changes and shall consult the 
relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority Medical Device       
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 shall take into account the data related to the usef ulness of incorporation of the substance into the 
device as determined by the notified body, in order to ensure that the changes have no negative 
impact on the established benefit/risk profile of the addition of the substance in the medical device. 
 
 
MDR – Annex IX 5.2 b 
 
(a) Where a device incorporates, as an integral part, a substance which, if used separately, may be 
considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 
2001/83/EC, including a medicinal product derive d from human blood or human plasma and 
that has an action ancillary to that of the device, the quality, safety and usefulness of the 
substance shall be verified by analogy with the methods specified in Annex I to Directive 
2001/83/EC. 
 
(b) Before issuing an EU technical documentation assessment certificate, the notified body shall, 
having verified the usefulness of the substance  as part of the device and taking account of the 
intended purpose of the device, seek a scientific opinion from one of the competent authorities 
designated by the Member States in accor dance with Directive 2001/83/EC or from the EMA , 
either of which to be referred to in this Section as ‘the medicinal products authority consulted’ 
depending on which has been consulted under this point, on the quality and safety of the 
substance including the benefit or risk of the incorporation of the substance into the device . 
Where the device incorporates a human blood or plasma derivative or a substance that, if used 
separately, may be considered to be a medicinal product falling exclusively within the scope of 
the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.  
 
(c) When issuing its opinion, the medicinal products authority consulted shall take into account the 
manufacturing process and the data relating to the usefulness  of incorporation of the substance 
into the device as determined by the notified body. 
 
II. Consultations for medical device s containing TSE susceptible an imal tissue 
under the MDR, where such a consultation took place under the M DD or 
AIMDD 
 
Article 5(4) of Regulation (EU) 722/2012 requires that for all medical devices, including active 
implantable medical devices, manufactured utilising tissues of animal origin which are susceptible to 
transmissible spongiform encephalopathy (TSE), the notified body must, through their competent 
authority, carry out a consultation of the other competent authorities and the Commission. 
Under the MDR, this requirement rema ins unchanged (Annex IX Section 5.3.2). 
In order to fulfil the requirements of the MDR, during the first certification under the MDR, the 
notified body is required to submit the full summary evaluation report as stated in Regulation (EU) 
722/2012 to the competent authorities. If there have been no changes to the documentation required 
from the manufacturer as per Regulation (EU) 722/2012, the summary evaluation report may be 
accompanied by a declaration by the notified body to this effect, stating the elements that have remained identical. If there have also been no changes to the assessment of this documentation by the 
notified body, this may also be included in th e declaration. Should there be only administrative 
changes to the above (e.g. changes of names or addresses, changes in document layout, etc.), these 
should be clearly detailed in the declaration.  Medical Device       
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As stated in Article 5(5) of Regulation (EU) 722/2012, the competent authorities and the Commission 
may agree on shortening the time periods for the consultation. If many elements of the summary evaluation report remain identical, it is highly recommended to expedite the review. 
Relevant text from Regulation (EU) 722/2012 
Article 5 (4) and (5) 4. Before issuing an EC design-examination certificate or an EC type-examination certificate, the 
notified bodies shall, through their competent authority, hereinafter ‘coordinating competent 
authority’, inform the competent authorities of th e 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;  
(b) in relation to medical devices using starting materials for which a TSE certificate of suitability has 
not been submitted, within 12 weeks from the date on which the notified body informed the 
coordinating competent authority pursuant to paragraph 4.  
The competent authorities of the Member States  and the Commission may agree on shortening the 
time periods set out in points (a) and (b).