Page 1 of 16 1 
   
 
 
 
MDCG 2020-10/1 
Safety reporting in clinical investigations 
of medical devices under the  
Regulation (EU) 2017/745  
 
 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 Europea n 
Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union ca n 
give binding interpretations of Union law.    
Page 2 of 16 MDCG 2020-10/1 
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
 
May 2020 
 
Table of contents 
1 INTRODUCTION .................................................. ............................................................... ............................................................... ........................................................ 3  
1.1 SAFETY REPORTING IN THE ABSENCE OF EUDAMED  .............................................................. ............................................................... ............................................................... ..... 3  
2 SCOPE ......................................................... ............................................................... ............................................................... ............................................................... . 4 
2.1 CLINICAL INVESTIGATIONS OF MEDICAL DEVICES  .............................................................. ............................................................... ............................................................... ......... 4  
2.2 MEDICAL DEVICES USED IN CLINICAL TRIALS OF MEDICINAL PRODUCTS (DRUG TRIALS ) ............................................................. ............................................................... ........................ 4  
3 DEFINITIONS ................................................... ............................................................... ............................................................... ............................................................ 5  
3.1 INVESTIGATIONAL DEVICE  .............................................................. ............................................................... ............................................................... ...................................... 5  
3.2 ADVERSE EVENT (AE) .......................................................... ............................................................... ............................................................... ............................................... 5  
3.3 SERIOUS ADVERSE EVENT (SAE).......................................................... ............................................................... ............................................................... ................................. 5  
3.4 DEVICE DEFICIENCY  .............................................................. ............................................................... ............................................................... .............................................. 5  
4 REPORTING METHOD .............................................. ............................................................... ............................................................... ................................................... 6  
4.1 TRANSITION TO REPORTING VIA EUDAMED  .............................................................. ............................................................... ............................................................... ............... 6  
4.2 OVERVIEW OF FORMATS TO BE USED BY SPONSORS WHEN REPORTING TO NCA S .............................................................. ............................................................... ............................. 6  
4.3 COLLECTING REPORTS FROM INVESTIGATORS  .............................................................. ............................................................... ............................................................... ............. 6  
5 REPORTABLE EVENTS ............................................. ............................................................... ............................................................... .................................................... 7  
5.1 EXCEPTIONS FOR PMCF  INVESTIGATIONS ACCORDING TO MDR  ARTICLE 74.1 .......................................................... ............................................................... ................................... 7  
5.2 REPORTABLE EVENTS OCCURRING IN THIRD COUNTRIES  .............................................................. ............................................................... .............................................................. 7 
5.3 TRANSITION PERIOD FOR REPORTABLE EVENTS IN PRE -MARKET CLINICAL INVESTIGATIONS INITIATED UNDER DIRECTIVES LEGIS LATION  .............................................................. ........................ 7  
5.4 TRANSITION FOR REPORTABLE EVENTS IN PMCF  CLINICAL INVESTIGATIONS INITIATED UNDER DIRECTIVES LEGISLATION  .............................................................. .......................................... 8  
6 REPORT BY WHOM ................................................ ............................................................... ............................................................... ..................................................... 8  
7 REPORT TO WHOM ................................................ ............................................................... ............................................................... ..................................................... 8  
8 REPORTING TIMELINES ........................................... ............................................................... ............................................................... .................................................... 8  
8.1 REPORT BY SPONSOR TO NCA S............................................................... ............................................................... ............................................................... .............................. 8  
8.2 REPORT BY THE INVESTIGATOR TO THE SPONSOR  .............................................................. ............................................................... ............................................................... ........ 9  
9 CAUSALITY ASSESSMENT .......................................... ............................................................... ............................................................... .................................................. 9  
10 REPORTING FORM ................................................ ............................................................... ............................................................... .................................................... 11  
10.1 COMPLETION GUIDELINES : FORM HEADER  .............................................................. ............................................................... ............................................................... .............. 11  
10.2 COMPLETION GUIDELINES : EVENT DETAILS  .............................................................. ............................................................... ............................................................... .............. 13  
11 REFERENCES .................................................... ............................................................... ............................................................... ......................................................... 16  
12 APPENDIX – CLINICAL INVESTIGATION SUMMARY SAFETY REPORTING FORM  .............................................................. ............................................................... .......... 16  
   
Page 3 of 16 1 Introduction 
 
Safety reporting in clinical investigations of medical devices shall be performed in line with the requirements of the Regulat ion (EU) 2017/745 – 
Medical Device Regulation (MDR) Article 80(2):   
The sponsor shall report, without delay to all Member States in  which the clinical investigation is being conducted, all of th e following by means of 
the electronic system referred to in MDR Article 73:  
a) any serious adverse event that has a causal relationship with t he investigational device, the comparator or the investigation procedure or 
where such causal relationshi p is reasonably possible;  
b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention ha d not occurred, 
or circumstances had been less fortunate;  
c) any new findings in relation to any event referred to in points  a) and b).  
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the spon sor may submit an 
initial report t hat is incomplete followed up by a complete rep ort.  
Upon request by any Member State in which the clinical investig ation is being conducted, the sponsor shall provide all informa tion referred to in 
paragraph 1. 
For post-market clinical follow up (PMCF) investigations of CE- marked devices1 used within the intended use covered by the CE-marking, report ing 
requirements of MDR Article 80(5) and (6) apply. This means tha t the vigilance provisions laid down in Articles 87 to 90 and i n the acts adopted 
pursuant to Article 91 shall apply for PMCF clinical investigat ions. However, this guidance document is still relevant for PMC F clinical investigations 
as the reporting of serious adverse events where a causal relat ionship to the preceding investigational procedure has been est ablished shall follow 
the reporting procedures of clin ical investigations as outlined  in Article 80. 
1.1 Safety reporting in the absence of Eudamed 
Since the electronic system referred to in Article 73 (Eudamed)  will not be available and fully functional at the Date of appl ication of the MDR this 
guidance outlines the procedures for safety reporting in clinic al investigations in the absence of Eudamed.  
This document defines Serious Ad verse Event (SAE) reporting mod alities and includes a summary tabulation reporting format. 
  
                                                           
1 The PMCF investigations referred to in MDR Article 74(1).  
Page 4 of 16 2 Scope 
2.1 Clinical investigation s of medical devices 
The reporting modalities and format set out in this guidance ap ply to:   
 Pre-market clinical investigations  covered by Articles 62 and 74(2) of the MDR conducted with: 
a) Non-CE marked devices, 
b) CE marked devices used outside the intended use(s) covered by t he CE-marking. 
c) The term pre-market clinical inv estigation may also include som e studies covered by MDR Article 82.  
 
As MDR Article 82 allows member states to define national requi rements for such clinical investigations, sponsors are encourag ed to check 
with the applicable NCA2 whether this guidance or other reporting procedures should be applied. 
In situations where a clinical investigation has started using a non-CE marked device, and the right to bear the CE marking ha s been obtained 
before the end of the clinical investigation, the SAE reporting  continues  until  completion of the investigation, according  to the clinical 
investigation plan and these guidelines apply throughout the SA E reporting period. 
 
For pre-market clinical investigations involving CE marked comp arator devices used within their intended purpose, SAEs occurri ng in or to 
subjects that are in the comparator arm of an investigation sha ll also be reported in accordance with these guidelines.  
 
Note: SAEs concerning CE marked devices which meet the vigilanc e reporting criteria also need to be handled under the post-mar ket 
surveillance/vigilance system.  
 
 Those Post-Market Clinical Follow Up (PMCF) investigations  that involve procedures additional to those performed under th e normal 
conditions of use of the device, and where those additional pro cedures imposed by the clinical investigation plan are invasive  o r  
burdensome, covered by MDR Article 74(1). For these clinical in vestigations the safety reporting for events pertaining to MDR Article 80(6) 
follow the Serious Adverse Event reporting process only, and ar e outlined in this guidance. Events pertaining to MDR Article 8 0(5) are 
reported following the vigilance process only and are outside t he scope of this guidance. 
 
 Note that other post-market clinical investigations may be subj ect to safety reporting requirements in line with this guidance  due to 
national requirements following MDR Article 82, but there is no  such general requirement. Sponsors are encouraged to check wit h the 
applicable NCA whether this guidance or other reporting procedu res should be applied. 
 
 Due to the transitional provisions in MDR Article 120(11) this guidance also covers clinical investigations which have started  to be conducted 
in accordance with Article 10 of Directive 90/385/EEC (AIMDD) o r Article 15 of Directive 93/42/EEC (MDD) prior to 26 May 2021.  These 
investigations may continue to be conducted after date of appli cation of the MDR, but the reporting of serious adverse events and device 
deficiencies shall be carried out in accordance with the MDR re quirements from 26 May 2021 and onwards.  
2.2 Medical devices used in clinical  trials of medicinal products ( drug trials)  
 A CE-marked device which is used outside its intended purpose, or a non-CE marked device in a clinical drug trial would implic itly have to 
be assessed for safety and performance and the study shall foll ow both MDR (Chapter VI) and the applicable legislation for cli nical drug 
trials. This guidance document is then relevant for compliance with the MDR regarding safety reporting.  
 
                                                           
2 For the purpose of this guidance," NCAs" encompasses the Natio nal Competent Authorities of the EEA, Switzerland and Turkey.   
Page 5 of 16  If a drug-device study (or a drug trial) is not undertaken to a ssess the safety or performance of a device used in the study, the reporting 
requirements of MDR Article 80 do not apply, as long as the dev ice is CE marked and used within its intended purpose. This gui dance is not 
applicable, but the vigilance re porting provisions of MDR apply  in those situations, as for any commercially available device.  Sponsors 
should make sure that the device manufacturer is notified about  any incidents related to the device and the legal manufacturer  of the 
device is responsible for the subsequent vigilance reporting.  
 
3 Definitions  
3.1 Investigational device  
A device that is assessed in a  clinical investigation  
(MDR Article 2(46)) 
 
Note: An investigational device can be a non-CE marked device o r a CE marked device. The definition in MDR Article 2(46) does not differentiate 
between different regulatory statuses of devices. However, the reporting requirements are different depending on whether the c linical 
investigation is done for purposes described in Article 62, 74 or 82. The definition is understood to cover also the devices i nvestigated in PMCF 
investigations, even if they are not subject to notification pe r Art 74.1. 
3.2 Adverse Event (AE)  
Any untoward medical occurrence, unintended disease or injury o r any untoward clinical signs, including an abnormal laboratory  finding, 
in subjects, users or other persons, in the context of a clinic al investigation, whether or not related to the investigational  device.  
(MDR Article 2(57)) 
Note:  
a. This definition includes events that are anticipated as well as  unanticipated events 
b. This definition includes events occurring in the context of a c linical investigation related to the investigational device, th e comparator or 
the procedures3 involved. 
3.3 Serious Adverse Event (SAE)  
Any adverse event that led to any of the following:  
a) death,  
b) serious deterioration in the health of the subject, that result ed in any of the following:  
i. life-threatening illness or injury,  
ii. permanent impairment of a body structure or a body function,  
iii. hospitalisation or prolongation of patient hospitalisation,  
iv. medical or surgical intervention to prevent life-threatening il lness or injury or permanent impairment to a body structure or a body 
function,  
v. chronic disease,  
c) foetal distress, foetal death or a congenital physical or menta l impairment or birth defect 
(MDR Article 2(58)) 
3.4 Device deficiency  
Any inadequacy in the identity, quality, durability, reliabilit y, safety or performance of an i nvestigational device, includin g malfunction, use errors 
or inadequacy in information supplied by the manufacturer.  
                                                           
3 For the purpose of safety reporting all activities related to the use of a medical device may be considered procedures  
Page 6 of 16 (MDR Article 2(59)) 
 
4 Reporting method 
A new template for the Summary Reporting Form should be used fo r all studies from 26 May 2021. The tabular format featured in the Appendix 
needs to be filled in/updated for each reportable event or for new findings/updates to already reported events. It shall be tr ansmitted to all NCAs 
where the clinical investigation is being performed. 
For more details on how to complete the form refer to section 10. Reporting form .  
4.1 Transition to reporting via Eudamed 
Once Eudamed is available and fully functional the obligations and requirements that relate to performing safety reporting via  Eudamed shall apply 
from the date corresponding to six months after the date of pub lication of the notice referred t o in Article 34(3) of the MDR.  
4.1.1 Ongoing events at time of transition to Eudamed 
It is acknowledged that at the time of transition to reporting via Eudamed, there will be ongoing events for which initial rep orts have been made 
according to the procedures described in this document. For the se reportable events follow-up and final reports will be submit ted to the NCAs by 
the same procedure, but all new reportable events shall be ente red in Eudamed.  
Whether retrospective uploading of previous event reports to Eu damed will be possible is not clear at the time this guidance i s issued.  
4.2 Overview of formats to be used b y sponsors when reporting to NC As 
 
Under directives legislation 
Until May 25th, 2021: The tabular format from MEDDEV 2.7/3 Appe ndix I should be used  
Transition period 
From May 26th, 2021 
and until Eudamed is 
available The Tabular format of this guidance (Appendix- Summary Reporting  
Form) should be used.  
When Eudamed is 
available but not yet mandatory and until the timepoint when Eudamed becomes mandatory Either the Tabular format of this guidance (Appendix- Summary 
Reporting Form) or the Eudamed web form can be used.  Note: Once the shift to Eudamed reporting has been made for a s pecific 
clinical investigation, Eudamed should continue to be used for reporting 
all new events and updates to those events throughout the remai nder 
of the clinical investigation. 
From the timepoint when Eudamed is mandatory*
*From the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of the 
MDR. Web form via Eudamed shall be used for all new events, and upda tes to 
those events.  
The Tabular format of this guidance (Appendix- Summary Reporting  
Form) can be used only to transmit follow-up reports/final repo rts to 
the NCAs on events which were in itially reported in this format .  
 
 
4.3 Collecting reports from investigators 
The format in which sponsors wish to receive single event repor ts from investigators will be up to the sponsor to design and t hey may be adapted 
to an individual clinical investigation. When sponsors design s uch reporting forms, they should consult this guidance document  to  e ns ure  al l  
relevant details are captured in the reports from the investiga tor, so that the sponsors can fu lfil their reporting obligation s.  
Page 7 of 16  
5 Reportable events  
For the purpose of this guidance and based on the definitions a bove, the following events are considered reportable events in accordance 
with MDR Art. 80(2):  
a) any serious adverse event that has a causal relationship with t he investigational device, the comparator or the investigation procedure or 
where such causal relationship is reasonably possible;  
b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention ha d not 
occurred, or circumstances had been less fortunate;  
c) any new findings in relation to any event referred to in points  a) and b).  
Serious adverse events related to a CE marked device which is p art of the investigation procedure (for example a CE-marked imp lanting tool used 
in combination with a non-CE marked investigational device) are  reportable per MDR Article 80(2) if there is a causal, (or rea sonably possible) 
relationship to the device, the comparator or the investigation  procedure. The reporting procedures described in this guide sh ould then be 
followed in addition to the normal vigilance reporting procedur es for CE marked devices.  
All causality assessments should be made using the guidance in section 9. Only causality level 1 (i.e. “not related”) is exclu ded from reporting. If 
either the sponsor or the investigator has assigned a higher ca usality level than "not related", the event should be reported.  
5.1 Exceptions for PMCF investigatio ns according to MDR Article 74. 1 
Following Article 74.1 the SAE reporting for these PMCF clinica l investigations is governed b y Articles 80(5) and 80(6).  
This means that the provisions o f vigilance laid down in Articl es 87-90 and acts adopted pursuant to Article 91 shall apply. H owever, the SAEs 
where a causal relationship between the serious adverse event a nd the preceding investigational procedure has been established  shall follow the 
reporting procedures of clinical investigations as outlined in Article 80.  
For the purpose of this guidance reportable events in PMCF clin ical investigations are thus those serious adverse events where  a causal relationship 
between the serious adverse event and a preceding investigation al procedure has been established.  
“Preceding investigational procedure” shall be understood as a procedure which is imposed by th e Clinical Investigation Plan a nd which has taken 
place before (or coincided in time) with the serious adverse ev ent. This includes but is not limited to the burdensome or inva sive procedure(s) 
which defines whether the study is subject to notification requ irements following MDR article 74(1).  
5.2 Reportable events occurring in Third Countries 
Reportable events occurring in Third Countries4 in which a clinical investigation is performed under the same clinical investigation plan 
have to be reported in accordance with this guidance to the NCA (s) of the European countries in which the clinical investigati on is being 
conducted.  
 The NCA shall start receiving the reportable events occurring i n Third Countries as soon as the clinical investigation is auth orised to start in 
that Member State.  
 Events occurring in Third Countries after the participating Eur opean sites have closed shall continue to be reported.  
5.3 Transition period for reportable events in pre-market clinical investigations initiated und er directives legislation 
It is acknowledged that the MDR implies changes to the reportin g requirements compared to the directives’ requirements where a ll SAEs should 
be reported regardless of relatedness. Under MDR sponsors are n o longer obliged to report SAEs that are “not related” to the c linical investigation 
                                                           
4 Countries other than Switzerland, Turkey and those belonging t o the EEA.  
Page 8 of 16 procedures or the investigational device. At the date of applic ation for MDR there will be ongoing events for clinical investi gations initiated under 
directives legislation. As from the 26th of May 2021 sponsors are no longer expected to submit follow-u p reports to NCAs for events that have been 
deemed “not related“ (see section 9 of this document for guidan ce on causality assessment). For ongoing events that have a cau sality assessment 
other than “not related” follow up reports will still have to b e provided.  
To facilitate the transition and give time for sponsors to upda te Clinical Investigation Plans and study procedures in clinica l investigations a sponsor 
may continue to report all SAEs t o NCAs until Eudamed reporting  is mandatory (see section 4.1 Transition to reporting via Euda med). This applies 
only to studies which have started to be conducted5 in accordance with Article 10 of Directive 90/385/EEC or Artic le 15 of Directive 93/42/EEC 
prior to 26 May 2021.  
5.4 Transition for reportable events in PMCF clinical investigation s initiated under dire ctives legislation  
In case of PMCF studies which required SAE reporting according to the Pre-MDR national legislations, MDR article 80 (5) and 80 (6) shall apply from 
May 26th, 2021.  
 
6 Report by whom  
Reportable events have to be reported by the sponsor of the cli nical investigation, which could be the manufacturer, the legal  representative 
or another person6 or entity,. 
 
7 Report to whom  
Reportable events must be reported at the same time to all NCAs  where the clinical investigation has commenced using the summary tabulation 
featured in the Appendix.  
A list of clinical investigation contact points within the NCAs  is published at the Commission's homepage. 
For the purpose of this guidance, an investigation is considere d to have commenced in an individual Member State: 
• For investigations under the directives: When the sponsor is au thorized to start the investigation in accordance with the noti fication 
procedures in that Member State. 
• For investigations started under the MDR: When the sponsor is a uthorized to start the investigation in that Member State in ac cordance 
with the provisions laid out in the MDR. 
Member States may also require separate reporting to the Ethics  Committee(s). 
 
8 Reporting timelines  
8.1 Report by sponsor to NCAs.  
The sponsor must report to all NCAs where the clinical investig ation is authorised to start: 
• For all reportable events as described in section 5 which indic ate an imminent risk of death, serious injury, or serious illne ss and that 
requires prompt remedial action for other patients/subjects, us ers or other persons or a new finding to it: Immediately, but not later 
                                                           
5 For the purpose of safety reporting this is defined as “Author ised to start in the individual Member State in line with appli cable directives legislati on, regardless of whether 
any subjects have been recruited in the Member State or not.”  
6 Contact person established by the sponsor in line with Article  62(2) if accepted by Member State.   
Page 9 of 16 than 2 calendar days after awareness by sponsor of a new report able event or of new information in relation with an already re ported 
event. 
This includes events that are of significant and unexpected nat ure such that they become alarming as a potential public health  hazard. It 
also includes the possibility of multiple deaths occurring at s hort intervals. 
These concerns may be identified by either the NCA or the manuf acturer. 
 
• Any other reportable events as described in section 5 or a new finding/update to it: Immediately, but not later than 7 calendar days 
following the date of awareness by the sponsor of the new repor table event or of new information in relation with an already r eported 
event.  
In some cases, a different periodicity or different modalities may be agreed between the participating NCAs and the sponsor ac cording to the 
investigation’s design and to the pathology under clinical inve stigation. This would allow implementation of adequate provisio n for clinical 
investigations in which SAE frequency is expected to be high du e to the natural progression of the disease (e.g. palliative on cology). 
8.2 Report by the investigator to the sponsor  
The sponsor shall implement and maintain a system to ensure tha t the reporting of the reportable events as defined under chapt er 5 will be 
provided by the investigator to the sponsor immediately, but no t later than 3 calendar days after investigation site study per sonnel’s 
awareness of the event.  
9 Causality assessment  
The relationshi p between the use of the medic al device7 (including the medical - surgical procedure) and the occurrence  of each adverse event 
shall be assessed and categorized.  
D u r i n g  c a u s a l i t y  a s s e s s m e n t  a c t i v i t y ,  c l i n i c a l  j u d g e m e n t  s h a l l  be used and the relevant documents, such as the Investigator’s Brochure, the 
Clinical Investigation Plan or the Risk Analysis Report shall b e consulted, as all the foreseeable serious adverse events and the potential risks are 
listed and assessed there8. The presence of confounding factors, such as concomitant medi cation/treatment, the natural history of the underlying 
disease, other concurrent illness or risk factors shall also be  c o n s i d e r e d .  
The above considerations apply also to the serious adverse even ts occurring in the comparison group. 
For the purpose of harmonizing reports, each SAE will be classi fied according to four different levels of causality: 
1. Not related 
2. Possible 
3. Probable 
4. Causal relationship 
The sponsor and the investigators will use the following defini tions to assess the relationship of the serious adverse event t o the investigational 
device, the comparator or the investigation procedure. 
1. Not related: Relationship to the device, comparator or procedur es can be excluded when: 
- the event has no temporal relationship with the use of the inve stigational device, or the procedures related to application of  the 
investigational device; 
                                                           
7 Intended as both investigational device and comparator.  
8 For a comparator device, the Operator’s Manual could be a rele vant document.  
Page 10 of 16 - the serious adverse event does not follow a known response patt ern to the medical device (if the response pattern is 
previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduct ion of the level of activation/exposure - when clinically feasi ble - 
and reintroduction of its use (or increase of the level of acti vation/exposure), do not impact on the serious adverse event; 
- the event involves a body-site or an organ that cannot be affec ted by the device or procedure; 
- the serious adverse event can be attributed to another cause (e .g. an underlying or concurrent illness/ clinical condition, an  effect 
of another device, drug, treatment or other risk factors); 
- the event does not depend on a false result given by the invest igational device used for diagnosis9, when applicable; 
In order to establish the non-relatedness, not all the criteria  listed above might be met at the same time, depending on the t ype of 
device/procedures and the serious adverse event. 
2. Possible: The relationship with the use of the investigational device or comparator, or the relationship with procedures, is w eak but 
cannot be ruled out completely. Alternative causes are also pos sible (e.g. an underlying or concurrent illness/ clinical condi tion or/and 
an effect of another device, drug or treatment). Cases where re latedness cannot be assessed, or no information has been obtain ed 
should also be classified as possible. 
3. Probable: The relationship with the use of the investigational device or comparator, or the relationship with procedures, seem s 
relevant and/or the event cannot be reasonably explained by ano ther cause. 
4. Causal relationship: the serious  adverse event is associated with the investigational device, co mparator or with procedures beyond 
reasonable doubt when: 
- the event is a known side effect of the product category the de vice belongs to or of similar devices and procedures; 
- the event has a temporal relationship with investigational devi ce use/application or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
- the serious adverse event follows a known response pattern to t he medical device (if the response pattern is previously known) ; 
- the discontinuation of medical device application (or reduction  of the level of activation/exposure) and reintroduction of its  use 
(or increase of the level of activation/exposure), impact on th e serious adverse event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness / clinical condition or/and an effect of another device, drug o r 
treatment) have been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigationa l device used for diagnosis10, when applicable; 
In order to establish the relatedness, not all the criteria lis ted above might be met at the same time, depending on the type of 
device/procedures and the serious adverse event. 
                                                           
9 If an investigational device gives an incorrect diagnosis, the  patient might, for example, receive an unnecessary treatment a nd incur all the risks that accompany that 
treatment, or might be incorrectly diagnosed with a serious dis ease. In other cases, the patient might not receive an effectiv e treatment (thereby missing out on the benefits 
that treatment would confer) or might not be diagnosed with the  correct disease or condition. 
10 If an investigational device gives an incorrect diagnosis, the  patient might, for example, receive an unnecessary treatment a nd incur all the risks that accompany that 
treatment, or might be incorrectly diagnosed with a serious dis ease. In other cases, the patient might not receive an effectiv e treatment (thereby missing out on the benefits 
that treatment would confer), or might not be diagnosed with th e correct disease or condition.  
Page 11 of 16 The sponsor and the investigators will distinguish between the serious adverse events related to the investigational device an d those related to 
the procedures (any procedure specific to the clinical investig ation). An adverse event can be related both to procedures and the investigational 
device. Complications caused by concomitant treatments not impo sed by the clinical investigation plan are considered not relat ed. Similarly, 
several routine diagnostic or patient management procedures are  applied to patients regardless of the clinical investigation p lan. If routine 
procedures are not imposed by the clinical investigation plan, complications caused by them are also considered not related.  
In some particular cases the event may not be adequately assess ed because information is insufficient or contradictory and/or the data cannot 
be verified or supplemented. The sponsor and the Investigators will make the maximum effort to define and categorize the event  a n d  a v o i d  
these situations. Where an investigator assessment is not avail able and/or the sponsor remains uncertain about classifying the  serious adverse 
event, the sponsor should not exclude the relatedness; the even t should be classified as “possible” and the reporting not be d elayed.  
Particular attention shall be given to the causality evaluation  of unanticipated serious adverse events. The occurrence of una nticipated events 
related could suggest that the clinical investigation places su bjects at increased risk of harm than was to be expected before hand. 
 
10 Reporting form  
The reporting form template for the summary SAE tabulation is g iven in the Appendix of this document.  
The reporting form is study specific and covers only a given cl inical investigation, defined by a distinct clinical investigat ion plan. English is the 
recommended language for the reporting form. The report form ca n be modified in any applicable software (not only Microsoft Ex cel) but 
the file needs to be compatible with Microsoft Excel when sent to the participating NCAs.  
The template form contains inserted filters and functionality t o facilitate use of preferred terminology in the reporting. The se are important for the 
analysis and should be maintained. 
Sponsors who generate the excel report file by automated proces ses may implement other technical features in their systems for  e x c e l  f i l e  
generation to ensure the preferred terms listed in metadata are  used.  
The table gives a cumulative overview of the reportable events per clinical investigation and will be updated and transmitted to participating 
NCAs each time a new reportable event or a new finding to an al ready reported event is to be reported. More detailed informati on has to be 
provided on request of an NCA, if so requested by using the ind ividual study specific reporting form (see further section 4.3 Collecting reports 
from investigators ).  
10.1 Completion guidelines: Form header 
10.1.1  EUDAMED/CIV-ID 
The union-wide Single Identification Number mentioned in MDR Ar ticle 70(1) will not be possible to generate until Eudamed for MDR is fully 
functional. For the transition period, clinical investigations will get tracking numbers (CIV-ID) upon registration in the Eud amed2 database which 
is performed by the NCA upon receipt of an application. This CI V ID is provided to the sponsor during the NCA’s handling of th e initial application 
for the clinical investigation and should be entered on the saf ety reporting form.  
The CIV ID should already be available for a clinical investiga tion started under the directives’ legislation, where it should  be indicated on the 
MEDDEV 2.7/3 reporting form etc. Sponsors who are not aware of the CIV ID of their clinical inv estigations are invited to cont act the concerned 
NCA to get this information.  
Page 12 of 16 10.1.2  Title of Clinical Investigation  
The identifying title of the Clinical Investigation. The title indicated here should be consistent with other title entries (s uch as in clinical investigation 
application form, clinical inves tigation plan cover page etc).  
10.1.3  CIP number/code 
The unique identification code or short name assigned to the sp ecific clinical investigation pl an by the Sponsor (numeric, alp hanumeric or acronym) 
should be indicated.  
10.1.4  Contact person 
Name, address, e-mail and telephone number should be provided f or the person who is sponsor’s point of contact in case NCA hav e follow up 
questions regarding submitted safety report forms.  
10.1.5  MS+NCA Reference numbers 
For each participating Member State indicate the country code11 and the NCA’s national reference number for the clinical inves tigation.  
Example:  
SE 5.1-20YY-XXXXXX DK 20YYXXXXXX 
10.1.6  No. of subjects enrolled to date total 
Indicate the total number of subjects who have been enrolled (p er date of report) in the clinical investigation globally.  
10.1.7  No. of subjects enrolled to date per country 
List all countries where the clinical investigation has been au thorised by date of report and indicate the number of subjects who have been enrolled 
in the clinical investigation (per date of report) in each coun try.  
10.1.8  Device type 
Indicate the type of device(s) assessed in the clinical investi gation (e.g. pacemaker, coronary stent, hip implant).  
10.1.9  Reference Member State 
Indicate the name of the Member State which drew the unique EUD AMED/CIV ID (normally the first Member State receiving an appli cation for 
the clinical investigation). Once the coordinated assessment pr ocedure (per MDR Article 78) is up and running, the coordinatin g Member State 
should be indicated here.  
10.1.10  No. of investigational devices used to date total 
Indicate the total number of investigational devices which have  been used (per date of report) in the clinical investigation g lobally.  
10.1.11  No. of investigational devic es used to date per country 
List all countries where the clinical investigation has been au thorised by date of report and indicate the number of investiga tional devices which 
have been used in the clinical investigation (per date of repor t) in each country. 
10.1.12  Date of report 
Indicate the date when the report is compiled for transmission to NCAs. Format DD/MM/YYYY.  
                                                           
11 Use ISO-3166-1 alpha-2 codes, i.e.two-letter country codes as defined in ISO 3166-1  
Page 13 of 16 10.2 Completion guidelines: Event details 
Each unique reportable event is presented in a separate line. U pdates to a previously reported event should be made by changin g the information 
in the same line, and clearly identified according to the princ iples described below.  
Any new information added in the form should be highlighted in bold and/or colour. This includes any new lines added and any c hanges made 
to the information in an already existing line.  
In the initial report, in any given line, no fields shall be le ft intentionally blank. To meet this requirement, preliminary i nformation should be filled 
in, despite the need of further updating.  
10.2.1  Status  
The sponsor shall identify the new/updated information in the s tatus column as: 
A = added = new reportable event; M = modified = new finding/update to an already reported event;   
U = unchanged. 
10.2.2  Date Sponsor received report of SAE/DD 
Indicate the date when the sponsor was first notified by the in vestigation site about the event. This date is checked for comp liance with reporting 
timelines as outlined in section  8 Reporting timelines .  
Format DD/MM/YYYY. 
10.2.3  Country code 
Indicate the country code
11 for the country in which the subject associated with the event  has been enrolled. 
10.2.4  Investigation site 
Name identifying institution or site where the clinical investi gation is carried out.  
10.2.5  Subject ID code 
The study specific subject ID code, i.e. the link between study  data and the actual subject identity (which is not to be provi ded in this form).  
10.2.6  SAE ID code 
The investigator, sponsor or manufacturer should assign a uniqu e ID to each SAE that has occurred, This number shall remain un changed 
throughout all other alterations of the particular SAE-reportin g due to ongoing assessment. 
10.2.7  Date of procedure/First use 
Indicate the date of the relevant procedure or the date when th e subject was exposed to the dev ice for first use. Format DD/MM /YYYY. 
10.2.8  Date of event onset 
The date when the first signs of an event were noticed may be d ifferent (earlier) than the date when the event fulfilled the s eriousness criteria 
(see further the definition in section 3.3 Serious Adverse Even t (SAE)). The date when the event became an SAE should be repor ted as Date of 
event onset. In case of Device Deficiencies which did not lead to an SAE, the date the DD was discovered should be indicated.  
Format DD/MM/YYYY. 
10.2.9  SAE or DD 
Choose one option from SAE(Seriou s Adverse Event) or DD (Device  Deficiency).  
Do not add other options.  
Page 14 of 16 10.2.10  Age 
The subject’s age at date of event onset should be indicated.  
In cases where exact date of birth is not available as a basis for age calculation, it is acknowledged that an approximate age  at date of event onset 
could be calculated based on the age at enrollment.  
Normally the Age should be indicated in Years, although for pae diatric/neonatal populations it may be more relevant to indicat ed age in months, 
weeks or days. When a different unit than years is used, the un it should be indicated as appropriate. 
10.2.11  Patient gender 
Choose one option from the following list (do not add other opt ions):  
 Female 
 Male 
 Other 
 Unknown 
10.2.12  Location of device 
For this field, it is the location of the device at the time th e report is submitted to NCA is of interest (i.e not at the tim e of investigator or sponsor 
awareness of the event). Changed location of the device is in i tself not a reason to provide an updated report. However, whene ver an update/final 
report is provided for other reasons, it is relevant to update this field if the device for example has reached the sponsor by  then. 
Choose one option from the following list (do not add other opt ions): 
 Investigational/study site 
 Sponsor 
 Subject 
 Manufacturer 
 Remains implanted 
 Discarded 
 Unknown 
 Other 
10.2.13  Classification of event 
Choose one option from the following list of consequence charac teristics (do not add other options):  
 Death 
 Life-threatening illness or injury 
 Permanent impairment/ Chronic disease 
 Hospitalization 
 Medical or surgical intervention 
 Foetal distress, fœtal death or congenital physical or mental o r birth defect 
 Not applicable (Note that this option is only to be selected in  case of reportable Device deficiencies that did not lead to an  SAE)  
Page 15 of 16 It is acknowledged that for a specific event two or more option s may be equally applicable, e.g. ” Hospitalization” and “medica l intervention”. The 
highest-ranking classification should be indicated, using the f ollowing ranking order: 1) Death , 2) life threatening, 3) foeta l distress, 4) permanent 
impairment, 5) Medical or surgic al intervention 6) hospitalizat ion. 
10.2.14  Description of event 
Provide a description of the event in free text. Below is a non -exhaustive list of items that  could be relevant to cover:  
 Nature of the observed symptoms 
 Duration and severity of the symptoms 
 Date of onset of first signs of the event (before it became a S AE) 
 Medical background of the patient 
 Medical care of the patient 
 Comments on the event in relation to already known safety data 
Use of standardised terminology corresponding to relevant IMDRF  codes is encouraged. 
10.2.15  Action/treatment /outcome 
Provide information in free text on actions taken, treatment(s)  administered and the outcome.   
10.2.16  Relationship to procedure 
Choose one option from the foll owing list of causality levels ( for explanatory texts see sect ion 9 Causality assessment): 
 Not related 
 Possible 
 Probable 
 Causal 
Please report the assessments by sponsor and investigator in th e respective columns.   
10.2.17  Relationship to device 
Choose one option from the foll owing list of causality levels ( for explanatory texts see sect ion 9 Causality assessment) 
 Not related 
 Possible 
 Probable 
 Causal 
Please report the assessments by sponsor and investigator in th e respective columns.  
10.2.18  Unanticipated SADE 
Choose option Yes or No 
An Unanticipated Serious Adverse Device Effect12 is an effect which by its nature, incidence, severity or outco me has not been identified in the 
current risk assessment. Procedure s associated with the use of a device should be addressed in the risk assessment, which make s it possible to 
                                                           
12 An adverse device effect is an adverse event related to the us e of an investigational device. A serious adverse device effect  is an adverse device effect that has resulted in 
any of the consequence characteristics of a serious adverse eve nt.   
Page 16 of 16 determine whether the procedure related SAEs are Unanticipated Serious Adverse Device Effect or not. SAEs related to procedure s imposed by 
the clinical investigation plan but not with the use of the dev ice should not be considered Serious Adverse Device Effects.  
10.2.19  Investigation arm 
Choose one option from the following list: 
 Test group 
 Comparison group 
 Blinded 
 Not applicable 
Note: For some study designs it might be more relevant to add n ame of device; i.e. in a clinical  investigation with several te st groups it might be 
useful to differentiate which investigational device that the s ubject has been exposed to.  
10.2.20  Event status 
Choose one option from the following list (do not add other opt ions): 
 Resolved 
 Resolved with Sequelae 
 Ongoing 
 Death 
10.2.21  Date of event resolution 
Add date in format DD/MM/YYYY. If event status is “Ongoing” ent er Not Applicable.  
 
11 References 
1. R e g u l a t i o n  ( E U )  2 0 1 7 / 7 4 5  o f  t h e  E u r o p e a n  P a r l i a m e n t  a n d  o f  t h e  council of 5 April 2017 on medical devices, amending Directive 
2001/83/EC, Regulation (EC No 178/2002 and Regulation (EC) No 1 223/2009 and repealing Council Directives 90/385/EEC and 93/42/ EEC.  
2. Council Directive 90/385/EEC of 20 June 1990 on the approximati on of the laws of the  Member States relating to active implantable medical 
devices, last amended by Directive  2007/47/EC. 
3. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, last amended  by Directive 2007/47/EC. 
4. Codes for the representation of names of countries and their su bdivisions – Part 1: Country codes (ISO 3166-1) published by In ternational 
Organisation for Standardization (ISO). 
 
12 Appendix – Clinical Investigation Sum mary Safety Reporting Form