Medical Device       
Medical Device Coordination Group Document                               MDCG 2020-11  
 
 
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MDCG 2020-11 
  
Guidance on the renewal of designation and 
monitoring of notified bodies under Directives 
90/385/EEC and 93/42/EEC to be performed in 
accordance with Commission Implementing 
Regulation (EU) 2020/666 amending Commission 
Implementing Regulation (EU) 920/2013   
             
 
May 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 the renewal of designation and monitoring of 
notified bodies under Directives 90/385/EEC and 93/42/EEC 
to be performed in accordance with  Commission 
Implementing Regulation (EU) 2020/666 amending 
Commission Implementing Regulation (EU) 920/2013  
 
1. Introduction 
The COVID-19 pandemic has created extraordinary circumstances that demand substantial 
additional resources, as well as a continued availability of vitally important medical devices, 
that could not reasonably have been anticipated at the time of adoption of Medical Devices 
Regulation (EU)  2017/745 (hereafter referred to as ‘MDR’). In order to allow Member States, 
health institutions and economic operators to prioritise the fight against the COVID-19 
pandemic it was considered necessary to defer the application of certain MDR provisions by 
one year (i.e. until 25 May 2021)1. To ensure the continuous presence of a functioning 
regulatory framework for medical devices it was necessary to also defer by one year the date 
of repeal of the Medical Devices Directives 90/385/EEC and 93/42/EEC (hereafter referred to 
as ‘the Directives’). 
The deferral of the date of repeal has a consequential impact on the designations of certain 
notified bodies under the Directives, including their ability to carry out their obligations and 
be operational until 25 May 2021. The current COVID-19 pandemic also affects the way in 
which designating authorities are able to perform the required appropriate surveillance and 
monitoring activities over notified bodies. To take account of these extraordinary 
circumstances, the Commission and the Member States, on 18 May 2020, adopted 
Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing 
Regulation (EU) 920/2013 as regards the renewal of designations and the surveillance and 
monitoring of notified bodies (hereafter referred to as ‘the Implementing Regulation’)2. The 
amendment provides for a derogation from certain requirements on the renewal of 
designations of notified bodies and for alternative surveillance and monitoring activities that 
designating authorities should carry out.  
In particular, in the interest of health and patient safety, and, to ensure consistency among the 
activities performed by designating authorities, this guidance document has been developed to 
outline common criteria for the renewal of designations of notified bodies under the 
Directives until 25 May 2021. In addition, this document intends to provide clarification on 
the appropriate activities performed by designating authorities over notified bodies in order to 
ensure an adequate level of surveillance in accordance with Article 5 paragraph 1, third 
subparagraph, of the Implementing Regulation. 
                                              
1 OJ L 130, 24.4.2020, p. 18–22. 
2 OJ L 156, 19.5.2020, p. 2–5  Medical Device       
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 2. Scope 
This guidance covers the following activities performed by designating authorities under 
exceptional circumstances, as referred to in Article 4(6) of the Implementing Regulation: 
 renewal of designation under the Directives of notified bodies whose designation 
expires in the period from 26 May 2020 to 25 May 2021; 
 surveillance activities to be performed by designating authorities in accordance with 
the Implementing Regulation under COVID-19 related restrictions, notably 
quarantine orders and travel restrictions. 
This guidance does not apply to the procedure for the initial designation of a notified body 
under the Directives nor to the procedures for extensions of the scope of a notified body nor 
the lifting of limitations to the scope of a notified body3. 
3. Renewal of designation of a notified body until 25 May 2021 
When deciding upon the renewal of the designation as a notified body in accordance with 
Article 4(6) of the Implementing Regulation, designating authorities should perform an 
appropriate assessment of the continuous competence of the notified body and its ability to 
accomplish the tasks for which it has been designated. 
Designating authorities should base their decision to renew a designation on a review of 
documents, resources and activities, which lay ground for the verification of the criteria for 
designation as set out in the Directives and in Annex I to the Implementing Regulation. 
This review should include in particular the following: 
 assessment of relevant quality management system procedures, forms and records, in 
particular qualification criteria, procedures for selection and authorisation of persons 
involved in conformity assessment activities, procedures to ensure independence, 
objectivity and impartiality of the notified body’s activities; 
 assessment of an appropriate number of the notified body’s reviews of the 
manufacturer’s technical documentation, including clinical evaluations; 
 assessment of an appropriate number of the notified body’s personnel files; 
 discussion of the results of the assessments of quality management documents and 
records with responsible personnel, including management responsible for the 
implementation and update of the quality management system as well as the notified 
body’s assessors responsible for product review, including clinical evaluation, final 
review and decision-making processes; 
 review of the outcome of the most recent on-site surveillance assessments and 
observed audits  as well as of recent extraordinary assessment activities conducted by 
the designating authority 
                                              
3 See Article 11 of Directive 90/385/EEC and Article 16 of Directive 93/42/EEC. Medical Device       
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 When performing the above-mentioned review, the designating authority could also consider, 
if relevant, the outcome of the most recent joint assessment carried out in accordance with 
Article 3 of the Implementing Regulation as well as joint assessments recently carried out in 
accordance with the MDR. 
In order to ensure a sufficient assessment the selection of the appropriate number of 
manufacturer’s technical documentation reviews and personnel files to be reviewed should 
take into account the volume of the activities performed by the notified body, its scope of 
designation and any relevant vigilance data. The designating authority should be able to 
justify the number and type of files selected. The designating authority should ask the notified 
body to implement appropriate measures to correct any non-conformities found during the 
review 
Normally, the renewal should include an on-site assessment. However, when exceptional 
circumstances prevent a designating authority from carrying out such an on-site assessment, 
alternative assessment measures should be used. Principles and arrangements of alternative 
measures described in Section 5 of this document concerning surveillance activities may 
apply. 
The results of the assessment performed by the designating authority should be documented 
and the final decision on the renewal of a designation should be substantiated. 
4. Notification and information to be provided to the Commission 
In accordance with Article 4(6) of the Implementing Regulation, any decision by a Member 
State on the renewal of a designation as a notified body should be notified to the Commission 
and the other Member States through the New Approach Notified and Designated 
Organisations information system (NANDO)  on or before the date of designation expiry. In 
line with the ordinary procedure, this should take place by means of submitting an update of 
the existing notification under the relevant Directive. 
The Commission may request further information relating to a decision taken by a designating 
authority on the renewal of a designation. In particular, designating authorities should make 
available, upon request from the Commission, the reports describing the assessments 
performed in relation to the renewal of the designation and the relevant outcome as described 
in Section 3 of this guidance. This should clearly document the basis for the renewal decision 
detailing the elements reviewed by the designating authority to substantiate the decision, 
including the results of any surveillance and monitoring activities as described in Section 5 of 
this guidance. Relevant notified body’s documentation should also be made available to the 
Commission on request. 
5. Surveillance activities to be performed under exceptional circumstances 
In the context of the current COVID-19 pandemic, the resulting travel and quarantine 
restrictions may significantly affect the ability of designating authorities to conduct their Medical Device       
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 mandatory surveillance and monitoring activities such as on-site assessments and observed 
audits of their notified bodies. Therefore, in accordance with Article 5(1) of the Implementing 
Regulation, in order to ensure an adequate level of surveillance, designating authorities should 
at least assess an appropriate number of notified body’s reviews of the manufacturer’s 
technical documentation, including clinical evaluations, and of personnel files, in addition to 
carrying out alternative surveillance measures. These alternative measures may include the 
following principles and arrangements: 
 on-site surveillance assessments may be replaced by remote surveillance assessments 
using the most advanced available Information and Communication Technologies as 
deemed appropriate in accordance with Union legislation on information security and 
data protection; 
 assessment of all relevant and required documents/records off-site. 
In order to ensure a sufficient assessment, the selection of the appropriate number of notified 
body’s reviews of the manufacturer’s technical documentation, including clinical evaluations, 
and personnel files to be reviewed, should take into account the volume of the activities 
performed by the notified body, its scope of designation and any relevant vigilance data. The 
designating authority should be able to justify the number and type of files selected.