Medical Device       
Medical Device  Coordination Group Document   MDCG  20 20-4   
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MDCG  20 20-4 
Guidance on temporary extraordinary  
 measures related to medical device Notified 
 Body audits during COVID -19 quarantine orders 
 and travel restrictions  
             
 
 April  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       
Medical Device  Coordination Group Document   MDCG  20 20-4   
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1.  Introduction  
In the context of the current COVID -19 global outbreak as well as the rapid spread of 
the virus across various regions of the globe, the resulting travel and quarantine 
restrictions have significantly affected the ability of notified bodies to conduct 
mandatory on -site audits under the medical devices legislation. Theref ore, in the 
interest of public health, this document has been developed to outline temporary 
extraordinary measures for notified bodies to follow in this interim period  in order to 
allow continued  availability of safe medical devices to the market and as sist in the 
prevention of  the risk of medical device shortages. In this context,  it is considered 
that alternative solutions to carrying out on -site audits by notified bodies under the 
medical devices Directives1 should be allowed under specific circumst ances, 
including the possibility to perform remote audits under certain conditions.  
This guidance takes immediate effect and is valid for the whole period of duration of 
the pandemic COVID -19 as declared by the World Health Organisation.  
2.  Scope  
This guida nce is intended to cover the following audits notified bodies are requested 
to carry out as part of medical devices conformity assessments:  
 surveillance audits under the medical devices Directives,  
 audits conducted for re -certification purposes under the medical devices 
Directives,  
 in cases where a manufacturer submits a change notification to a notified body 
that would typically require on -site audit or verification,  
 in cases where a manufacturer terminates (voluntarily or involuntarily) its 
contract with a notified body and enters into a contract with another notified 
body in respect of the conformity assessment of the same device(s).  
Although this guidance applies to the medical device Directives only, for Regulations 
(EU) 2017/745 (MDR) and 2017/746  (IVDR) in the event that the availability of 
devices is affected by COVID -19 restrictions the principles in this guidance may 
apply.  
 
 
                                                           
1Directive 90/385/EEC, the AIMDD; Directive 93/42/EEC, the MDD; Directive 98/79/EC, the IVDD.  Medical Device       
Medical Device  Coordination Group Document   MDCG  20 20-4   
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The temporary extraordinary measures proposed in this guidance should not apply to 
unannounced audits, or, to special a udits which require on -site assessment (such as 
the verification of implementation of specific corrective actions which can only be 
assesed on -site). This does not prevent the use of the alternative measures for these  
types of audits in cases where doubt has been raised on the conformity / safety  of a 
device and it is not in the interest of public safety to wait  until the end of the 
restrictions put in place due to the COVID -19 pandemic.  
In general, initial certification audits or audits to extend the s cope of certification 
under the Directives should not be performed using these temporary extraordinary 
measures. However, notified bodies may apply these extraordinary measures on a 
case -by-case basis for such audits in cases where devices are considered r elevant to 
ensure medical care, especially if clinically necessary during the period of COVID -19 
restrictions.  
3.  Proposed temporary alternative extraordinary measures and 
arrangements to on -site audits  
Notified bodies may introduce temporary alternative extraordinary measures in place 
of on -site conformity assessment audits that have been impacted by COVID -19 
restrictions and that are within the scope of section 2 above.  
Notified bodies should have documented procedures detailing the alternative 
temporary measures to be utilised and should define the criteria for implementing 
such measures (e.g. procedure for “force majeure”). The relevant procedures should 
also take into account the technologies to be used during such audits and also 
address the impact of the alternative measures on the audit duration.  
These temporary alternative extraordinary measures may include the following 
principles and arrangements:  
 Postponement of  on-site surveillance audits under the Directives in line with 
documented procedures of the notified body for force majeure.  
 On-site audits may be replaced by remote audits using the most advanced 
available Information and Communication Technologies as ap propriate in 
accordance with legislation on information security and data protection.  
 Assessment of all relevant and required documents/records off -site by the 
notified body.  
 To take into account existing recent results from  MDSAP audits (or other 
approp riate audits) in lieu of Directive audits, where available  
 To consider published international guidance such as those issued by the 
International Accreditation Forum (IAF) e.g. on how to use information and  
 
 
 Medical Device       
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communication technologies2 and for alternat ive auditing methods in 
extraordinary circumstances3. 
4.  Eligibility criteria and procedural aspects  
To be eligible for these temporary alternative extraordinary measures the audits must 
be covered within the scope of section 2 above.  
The possibility to make use of temporary alternative extraordinary measures to on -
site audits should be carefully assessed and documented by notified bodies on a 
case -by-case basis and performed using a risk -based approach. In particular, when 
determining the possibility to use t hese alternative measures, the risk assessment 
should take into account the experience gained with a manufacturer. For example,  
manufacturers who have a history of a high number and/or critical non -compliances 
related to production/operational control  ma y have an impact on the appropriateness 
to conduct such temporary measures. However, in these cases an alternative 
measure could be performed as a temporary measure to assess the progress of the 
manufacturer and should be be supplemented by an on -site audi t once travel 
restrictions are lifted.  
In order to assess which alternative extraordinary measure (as outlined in section 3 
above) is most appropriate, the notified body should review their files relating to the 
status and operations of the manufacturer re lated to the audit in question, for 
example the activities conducted at the site to be audited,  its quality management 
system, and its level of compliance from previous audits. Following this review, a risk 
analysis should be made as to whether or not the  audit could be performed with 
alternative measures. Where a postponement cannot be justified, the notified body 
should assess which alternative extraordinary measure should be performed (e.g. 
remote audit; off -site document review; conference calls with r elevant personnel of 
the manufacturer).  
For remote audits, both the notified body and the manufacturer must have the 
required information and communication technologies or tools available and 
established (e.g. web conferences with document sharing, use of  web cams for 
audits of production lines). Confidentiality of intellectual property aspects shall be 
safeguarded.   Notified bodies should clearly document and communicate any such 
requirements for their audits with their auditees, along with the required 
documentation to be shared before and within such audits, including the necessary 
data protection and cybersecurity measures . The technological capability of the  
manufacturer to ensure that such an audit can be accomplished should be verified by 
the notified body in advance of the audit.  
 
                                                           
2 Requirements on how to use information and communication technologies to support and maintain the 
integrity of the audit/assessment process may be found in International Accreditation Forum document IAF MD 
4 (Mandatory Document for the Use of Information and Communication Technology (ICT) for 
Auditing/Assessment Purposes).  
3 ID3:2011  (IAF Informative Document For Management of Extraordinary Events or Circumstances Affecting 
ABs, CABs and Certified Organizations)  Medical Device       
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Designating Authorities may request to observe/witness such remote audits  via 
information and  communication technologies or to ols available and established.  
When establishing the audit plan, the notified body should adjust the duration for 
review of the areas on the audit plan, along with the overall duration of the audit, in 
coordination with the manufacturer in order to make ef fective use of these alternative 
extraordinary measures. The audit plan should also clearly indicate which alternative 
extraordinary measures will be used and what will be conducted remotely. When 
issuing their audit reports the notified body should also c learly indicate that the audit 
was conducted remotely and the method(s) used for such audits should also be 
specified.  
Remote surveillance audits should cover all of the surveillance tasks that can be 
verified remotely, including an off -site review of all  documents that would normally be 
assessed on -site.  
Following such an alternative extraordinary measure the notified body should review 
and adjust the audit programme for each manufacturer to ensure that all required 
elements are assessed during the certi fication cycle.   
5.  Decisions taken on certification  
Remote audits undertaken for re -certification purposes should cover all of the 
mandatory re -certification tasks that can be verified remotely. Subsequent to a 
succcessful remote audit a notified body may r e-issue the certification with the 
condition that such audits should be followed up by an on -site verification audit at the 
next available opportunity to verify the elements that could not be assessed remotely 
(the timeline for the on -site verification aud it should be justified by the notified body). 
At the request of the notified body, the manufacturer may provide the notified body 
with records (e.g. product release documentation) on an ongoing or regular basis,. If 
the re -certification remote audit is uns uccessful, the certification should be 
suspended or should expire as appropriate.   
Remote audits conducted by the incoming notified body in the context of cases 
where a manufacturer terminates its contract with a notified body and enters into a 
contract with another notified body in respect of the conformity assessment of the 
same device (s), should also cover all of the tasks that can be verified remotely to 
allow the incoming notified body to ensure a proper assessment of the conformity of 
the device. If the remote audit is unsuccessful (as per the notified body’s procedures 
for unsucces sful audits), the incoming notified body should not issue the certification.  
In the exceptional circumstance of the issuance of  an initial or extended scope 
certificate under these alternative extraordinary measures (as per section 2 Scope 
above), the no tified body should consider the clinical risk / benefit of their decision 
and should clearly document their rationale for these decisions. At the request of the 
designating authority the notified body should inform the national authority of any 
such decisi ons and provide any supporting documentation.  Medical Device       
Medical Device  Coordination Group Document   MDCG  20 20-4   
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Note: A  task force established in March 2020 under the MDCG NBO working group 
is tasked with the development of guidance to define the operational implementation 
details of this guidance document.