Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -8   
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MDCG  2018 -8 
Guidance on c ontent of the certificates,    
 voluntary certificate transfers  
                 
 
 
 November 2018  
 
 
  
 
 
 
 
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 Commissi on 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 Devices       
Medical Devices Coordination Group Document   MDCG  2018 -8   
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In the meeting of 30 November 2018, MDCG endorsed the below positions. These 
positions will be part of a more comprehensive guideline related to notified bodies, 
currently under development.  
 
Content of the certificate under MDR / IVDR Annex XII, Chapter II, section 10  
Certificates do not need to include reference to relevant common specifications or 
harmonised standards as long as such information on all examinations and tests 
performed is traceable and available from e.g. report(s) which are ment ioned in the 
certificate.  
 
Voluntary certificate transfer under MDR Article 58 / IVDR Article 53  
While MDR Article 58(1) / IVDR Article 53(1) sets out the requirements for a transfer 
agreement, it does not specify the conformity assessment activities to be  performed 
by the incoming NB. The incoming NB may decide not to carry out full conformity 
assessment activities according to Article 52 MDR / Article 48 IVDR, as long as it 
does have sufficient information in respect to the conformity activities performed  by 
the outgoing NB.  
For quality management system certificates, the incoming NB needs to perform 
appropriate on -site audit(s) and assessments to ensure that the manufacturer in 
question applies the approved QMS and the post -market surveillance plan prior to 
the issue of any certificate. In respect to the assessment of technical documentations 
on a sampling basis, the oncoming NB shall review the previous assessment results 
together with a sample of a  technical documentation and draw up or amend a 
sampling plan. For product certificates (Annex IX Chapter II/Annex X), new 
certificates without a  comprehensive (initial) review may be issued as long as the 
documentation received does not identify ongoing existing or other concerns.  
The incoming NB assumes full responsibility for the new certificates issued following 
the transfer.