Exploiting globally available safety information on medical devices to support EU market surveillance/vigilance : an analysis of available data sources and their systematic and consistent use.
Date: 2019-08-14
Institutions: Joint Research Centre
Subjects: accident prevention, data collection, health policy, medical data, medical device, patient's rights, report

Exploiting globally available 
safety information on medical 
devices to support EU market 
surveillance/vigilance 

An analysis of available 
data sources and their 
systematic and 
consistent use 

Faraulo F., Griesinger C. B. 

2017  

EUR 28571 EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This publication is a Technical report by the Joint Research Centre (JRC), the European Commission’s science 
and knowledge service. It aims to provide evidence-based scientific support to the European policymaking 
process. The scientific output expressed does not imply a policy position of the European Commission. Neither 
the European Commission nor any person acting on behalf of the Commission is responsible for the use that 
might be made of this publication. 

Contact information  
Name: Claudius Benedict Griesinger 
Address: Via E. Fermi 2749, I-21027 ISPRA (VA), Italy 
Email: claudius.griesinger@ec.europa.eu  
Tel.: +39 0332 78 6726 

JRC Science Hub 
https://ec.europa.eu/jrc 

JRC105914 

EUR 28571 EN 

PDF 

ISBN 978-92-79-68182-0 

ISSN 1831-9424 

doi:10.2760/006806 

Luxembourg: Publications Office of the European Union, 2017  

© European Union, 2017 

The reuse of the document is authorised, provided the source is acknowledged and the original meaning or 
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Contents 

1  Introduction ...................................................................................................... 4 

2  A possible work procedure for the management of extra EU safety information: the 
NCAR exchange framework ..................................................................................... 5 

3  Analysis of publicly available sources of alerts, recalls and other relevant information 6 

3.1  IMDRF members .......................................................................................... 6 

3.1.1  AUSTRALIA - Therapeutic Goods Administration....................................... 6 

3.1.2  BRAZIL - Brazilian Health Surveillance Agency ......................................... 8 

3.1.3  CANADA - Health Canada ...................................................................... 8 

3.1.4  CHINA - China Food and Drug Administration .......................................... 9 

3.1.5  JAPAN - Pharmaceuticals and Medical Devices Agency ............................ 10 

3.1.6  SINGAPORE - Health Sciences Authority ............................................... 11 

3.1.7  RUSSIA - Federal Service on Surveillance in Healthcare and Social 
Development............................................................................................... 12 

3.1.8  USA - Food and Drug Administration .................................................... 13 

3.2  Non-IMDRF members ................................................................................. 16 

3.2.1  ARGENTINA – National Administration of Drugs, Food and Medical Devices 16 

3.2.2  MEXICO – Federal Commission for the Protection against Sanitary Risks ... 16 

3.2.3  NIGERIA - National Agency for Food and Drug Administration and Control 17 

3.2.4  SAUDI ARABIA - Saudi Food and Drug Authority .................................... 17 

3.2.5  SOUTH AFRICA – National Department of Health ................................... 18 

3.3  Quantitative analysis of extra-EU alerts and recalls ........................................ 19 

3.4  Compilation of recalls and alerts occurring over a six week period.................... 26 

3.5  IT tools for automated collection and analysis of alerts and recalls ................... 27 

3.5.1  DG JRC's translation tool .................................................................... 28 

4  Supplementary material ................................................................................... 29 

5  Conclusions .................................................................................................... 30 

References ......................................................................................................... 32 

List of abbreviations and definitions ....................................................................... 34 

List of figures ...................................................................................................... 36 

List of tables ....................................................................................................... 37 

i 

Abstracts 

Aim of the report 

This  report  provides  a  thorough  analysis  of  the  totality  of  globally  available  regulatory 
data sources on alerts, recalls and other safety information on medical devices that, until 
now, have not been systematically used by any single regulatory authority, including the 
EU.  This  amounts  to  a  potential  considerable  neglect  of  potentially  valuable  information 
on  safety-related  medical  device  issues  encountered  around  the  world.  From  an  EU 
regulatory  perspective,  this  is  of  particular  importance  in  case  such  devices  are  also  on 
the  market  in  the  EU.  However  since  the  issues  may  cover  a  large  spectrum  of  post-
market  'adverse  events'  /  incidents  (GHTF/SG2/N54R8:20061),  they  may  inform  also 
about more general issues, even if the specific product is not on the market.  

The  issues  may  range  from  medical  device  problems  and  failures  that  had  no  patient 
effects (yet), medical device problems with clear causal effects on patient/user health as 
well as adverse effects in patient/users that may be linked to the use of a given device or 
device type. Thus, such information is valuable from various perspectives by providing an 
additional  data  source  for  risk/signal  detection  complementing  manufacturers'  incident 
reports and thus providing means for early patient protection. Importantly, it could lead 
to the systematic detection of associations between specific products/product categories 
and  adverse  health  effects  and  enable  a  better  understanding  of  possible  issues  with 
materials,  biocompatibility,  procedure  of  use  etc,  opening  ultimately  possibilities  to 
assess,  in  a  more  systematic  manner,  specific  adverse  health-effect  pathways,  thus 
leading to improved design ('safety-by-design' concept). 

With  regard  to  data  types,  the  report  focuses  on  alerts  and  recalls,  as  provided  by  the 
official websites of thirteen non-EU regulatory authorities. Thus, in contrast to the JRC's 
MediSys  analysis  tool  which  searches  and  monitors  only  media  reports  on  medical 
devices,  this  report  addresses  curated  information,  i.e.  which  has  been  thoroughly 
assessed and approved for publication by official bodies.  

The  identified  sources  (webpages)  and  data  types  have  been  deeply  analysed  and 
described.  

Moreover, during a period of six weeks, all alerts and recalls from the identified sources 
have  been  compiled  and  listed  in  tabular  format  (see  supplementary  material).  This 
compilation  can  serve  as  a  basis  further  work  in  view  of  exploring  the  most  effective 
ways  to  use,  in  the  context  of  vigilance  and  market  surveillance  activities,  this 
information to detect safety problems in the EU territory and prevent or promptly react to 
them. 

The analysis conducted in this report addresses the following key questions:  

1.  Are  the  terminology  and  format  used  worldwide  sufficiently  targeted  and 
adequate to allow for effective analysis of information and detection of signals? 

2.  What are the benefits and added value of automated collection and display of 
globally available safety information for patient safety in the EU? Would it support 
the systematic use of such information? 

3.  Is  automated  collection  of  such  information  technically  feasible?  This 
would include intra- and extra EU alerts, recalls and other safety communications 
(e.g. Field Safety Notices and Incident Reports)  

4.  What are the  technical tools that are  required to create an  effective functional 
system  for  automated  and  systematic  collection,  translation  and  preliminary 
analysis of global safety data? 

1 Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices. 

1 

 
                                           
Key findings  

The report sets the framework of existing sources of alerts and recalls occurred in some 
of the most relevant markets of medical devices worldwide.  

In  particular, it  describes  these  sources  and  outlines  the  main  differences  regarding  the 
information they provide. 

The  report  is  complemented  by  a  quantitative  and  qualitative  analysis  of  real  cases  of 
global alerts and recalls collected over a six week period from official websites of selected 
regulatory authorities.  

This  compilation  includes  inputs  and  suggestions  for  further  discussion  regarding  the 
potential value and usefulness of the information. 

In this respect, the report shows a number of important issues relating to four key areas: 

1. Data set 

The  amount  of  available  data  relating  to  alerts,  recalls  and  other  safety  relevant 
communications is considerable.  

Importantly, the terminology used by the different regulators to label specific pieces of 
information is not fully harmonised. 

Furthermore,  the  information  provided  by  the  relevant  authorities  is  displayed  in 
fragmented ways, ranging from simple lists to structured databases.  

2. IT and translation tools  

The  data  to  be  retrieved  throughout  the  different  sources  showed  to  be  extensive, 
complex, fragmented, and of multilingual nature.  

In light of this, specific IT tools in support of effective collection, analysis and display 
of information seem to be needed.  

This includes translation tools from various languages into English, means of checking 
the identity of a given entity (e.g. company) etc. 

3. Relevance of existing data for the EU 

Only  one  of  the  analysed  sources  (i.e.  FDA  website)  provides  the  list  of  countries 
(including  EU  members)  where  the  given  product  affected  by  a  safety  issue  is 
circulated on the market. 

The  information  regarding  the  presence  on  the  Union  market  of  safety  measures 
occurred outside Europe is key for EU CAs to timely react to possible problems in the 
EU.  

However, even in case the devices is not on the market, the safety issue may point to 
flaw or failure relating to issues such as materials, biocompatibility or procedure which 
may  be  applicable  to  other  devices  and  hence  provide  early  warnings  with  regard  to 
possible imminent safety issues. 

4. Practical working procedure for data management  

Globally available data on alerts and recalls and other safety relevant communications 
are not systematically and appropriately shared.  

In  order  for  the  EU  to  take  advantage  of  their  potential,  Member  State  (MS)  CAs 
should ensure effective coordination and full share of similar information.  

2 

 
 
 
The  report  finally  provides,  as  supplementary  material,  a  data  compilation  of  alerts  and 
recalls collected during a six-week scoping exercise. 

This activity was mainly conducted to provide relevant actors (e.g. EU CAs, Commission, 
other  extra-EU  regulators)  with  a  real  picture  of  the  amount  and  type  of  global 
information which a regular monitoring activity could provide. The results of the scoping 
exercise  are  intended  to  serve  as  a  basis  for  the  identification  of  key  issues  relating  to 
the management and exploitation of global alerts and recalls.  

However,  the  results  would  be  highly  relevant  for  discussions  at  the  level  of  the 
International  Medical  Device  Regulators  Forum:  the  implementation  of  one  single  tool 
that  collects  and  displays  globally  available  curated  safety  information  (including  from 
EU)  and  provides  an  English  translation  as  well  as  an  entity  check,  would  support 
competent  authorities  worldwide  and  facilitate  their  cooperation  in  view  of  market 
surveillance, vigilance and patient protection. 

3 

 
1  Introduction 

This  report  provides  a  comprehensive  overview  of  additional  official  sources  of 
information  made  publicly  available  by  thirteen  regulatory  authorities  responsible  for 
vigilance  of  medical  devices2  outside  the  European  Union,  as  provided  through  their 
governmental websites.  

In particular, the document outlines and describes these extra EU sources of information 
(with  a  special  focus  on  alerts  and  recalls)  and  stresses  the  important  role  that  these 
data could play in support of the EU CAs for early detection of safety problems (signals) 
with medical devices in Europe.  

In order to benefit from this key information, it will be of utmost importance to use it in a 
systematic way that allows identifying the relevance of the collected extra EU alerts and 
recalls  for  European  territory,  including  the  case  when  the  concerned  products  are  not 
placed on the Union market.  

In  order to  establish a  complete  framework  of the available safety  communications, the 
report  also  contains  a  description  of  information  other  than  alerts  and  recalls,  such  as 
Field Safety Notices (FSNs) and incident reports.  

The  analysis  covers  all  the  members3  of  the  International  Medical  Device  Regulators 
Forum (IMDRF), except from the EU; in order to ensure geographic balance between the 
different regions of the world, this report also takes into account five of the biggest and 
most representative medical devices' markets among the non-IMDRF countries4.  

The  set  of  information  described  and  analysed  in  this  report  is  part  of  the  effort  of  the 
Joint  Research  Centre  (JRC)  to  facilitate  the  identification  of  means  for  a  strengthened 
vigilance  and  market  surveillance  activity  of  the  European  Union  in  the  field  of  medical 
devices.  This  may  include  a  management  tool  for  the  systematic  collection  and 
preliminary  analysis  of  globally  available  safety  information  for  possible  signal  detection 
in the EU. With MediSys the JRC has already installed a tool for monitoring international 
media reports on medical devices. This could, in the future, be  complemented by a tool 
for collecting regulatory information on alerts and recalls.  

2 The term medical device is meant to include also in vitro diagnostics and active implantable medical devices. 
3 AUSTRALIA-Therapeutic Goods Administration, BRAZIL-Brazilian Health Surveillance Agency, CANADA-Health 
Canada,  CHINA-China  Food  and  Drug  Administration,  JAPAN-Pharmaceuticals  and  Medical  Devices  Agency, 
RUSSIA-Federal  Service  on  Surveillance  in  Healthcare  and  Social  Development,  USA-Food  and  Drug 
Administration. 
4 ARGENTINA-National Administration of Drugs, Food and Medical Devices, MEXICO-Federal Commission for the 
Protection  against  Sanitary  Risks,  NIGERIA-National  Agency  for  Food  and  Drug  Administration  and  Control, 
SAUDI ARABIA-Saudi Food and Drug Authority, SOUTH AFRICA-Department of Health. 

4 

                                           
2  A possible work procedure for the management of extra 
EU safety information: the NCAR exchange framework 

The  large  amount  of  safety  information  available  globally  poses  the  issue  of  its  regular 
monitoring  and  good  management.  It  is  therefore  very  important  for  the  EU  CAs  to  set 
up  a  system  allowing  for  effective  use  and  share  of  all  collected  extra  EU  safety 
information. 

At  EU  level,  the  Competent  Authorities  for  medical  devices  have  put  in  place  a  working 
procedure to analyse safety problems occurred in the their territory and exchange views 
regarding the actions needed.  

This  procedure  is  based  on  monthly  teleconferences  that  are  coordinated  by  the 
Directorate-General  for  Internal  Market,  Industry,  Entrepreneurship  and  SMEs  (DG 
GROW) of European Commission in the framework of the activities of its Medical Devices 
Expert Group (MDEG) on Vigilance. 

These  teleconferences  focus  on  the  analysis  of  information  on  adverse  events  as 
disseminated through the National Competent Authority Reports (NCARs).  

The information contained in the NCARs as well as the extra EU alerts and recalls fall in 
the  vigilance/market  surveillance  area  and  both  require  a  prompt  and  coordinated 
reaction by the EU Competent Authorities.  

Therefore,  the  work  procedure  based  on  monthly  teleconferences  already  applied  to 
NCARs could possibly be expanded to extra EU alerts and recalls. 

A  coordinated  management  of  this  information  would  contribute  to  the  improvement  of 
the protection of health and safety of patients by reducing the likelihood of recurrence of 
incidents  and  preventing  their  repetition  through  the  adoption  of  appropriate  and 
concerted field safety corrective actions.  

It  is  to  be  noted  that  this  activity  is  closely  related  to  the  NCAR  Exchange  Program 
established  by  the  Global  Harmonisation  Task  Force  (GHTF5)  and  currently  being 
reviewed by the IMDRF.  

Following  the  NCAR  Exchange  Program,  29  regulators  committed  to  exchange 
confidential  information  on  adverse  events  with  regard  to  medical  devices  with  global 
distribution.   

The  NCAR  Exchange  Program  and  the  information  shared  at  international  level  should 
therefore be taken into account by the EU CAs when analysing extra EU safety data. 

5  The  ‘Global  Harmonization  Task  Force  (GHTF)’  is  a  voluntary  international  group  of  representatives  from 
medical device regulatory authorities and trade associations from Europe, the United States  of America (USA), 
Canada,  Japan  and  Australia.  GHTF  was  conceived  in  1992  in  an  effort  to  respond  to  the  growing  need  for 
international harmonisation in the regulation of medical devices. The GHTF mission ended in December 2012. 

5 

                                           
3  Analysis of publicly available sources of alerts, recalls and 

other relevant information 

This  section  illustrates  and  describes  the  sources  of  information  on  alerts,  recalls  and 
other  safety  relevant  information  made  available,  through  their  official  websites,  by 
thirteen regulators in different regions of the world (See Chapter 1).  

Although  focusing  on  alerts  and  recalls,  the  report  also  takes  into  account  other  safety 
information  potentially  relevant  for  early  detection  of  risks,  problems  or  incidents  with 
medical devices in the EU.  

The review of the different sources of information showed that, the terminology used and 
the  description  provided  by  the  different  regulatory  authorities  to  identify  alerts,  recalls 
and other warning information are quite heterogeneous. 

It is, therefore, important to reflect on the development of an internationally harmonised 
"language" for the description of safety measures.  

Future  possible  changes  of  the  state  of  play  of  the  sources  relating  to  the  jurisdictions 
covered  by  this  report  will  be  closely  monitored  and  regular  updates  will  be introduced, 
as needed.  

In the  same  way, additional relevant regions of the world may be taken into account in 
the future. 

3.1  IMDRF members 

3.1.1  AUSTRALIA - Therapeutic Goods Administration   

The  Therapeutic  Goods  Administration  (TGA6)  is  part  of  the  Australian  Government 
Department  of  Health  and  Ageing,  and  is  responsible  for  regulating  therapeutic  goods 
including medicines, medical devices and in vitro diagnostics, blood and blood products. 

including  contents  and 
in  Australia,  therapeutic  goods, 
Before  being  supplied 
classification  details,  are  registered  by  TGA  in  the  Australian  Register  of  Therapeutic 
Goods (ARTG7) database.  

The  official  webpage  of  the  TGA  includes  a  specific  section  called  "safety  information" 
which  provides  information  on  current  and  historic  recalls  of  medicines  and  medical 
devices,  advice  issued  by  TGA  about  products,  monitoring  communications,  information 
on reporting problems and how the safety of therapeutic products is monitored. 

TGA  provides  a  service  for  automatic  safety  information  updates  that  can  be  activated 
through the following sections of its website:  

 "Medical  Devices  Safety  Update  email  list"  (system  notifying  subscribers  when  the 
latest version of the Medical Devices Safety Update is available on the TGA website, 

 "Safety Information  email list" (system notifying subscribers when new alerts,  recalls 

and advisory statements are published on the TGA website). 

The information provided by this section of the TGA webpage is divided into the following 
sections. 

Recalls  

Recalls  are  conceived  as  those  actions  taken  to  resolve  a  safety,  quality,  efficacy  or 
presentation problem or deficiency with a device already supplied in the market.  

6 https://www.tga.gov.au/.  
7 https://www.tga.gov.au/searching-australian-register-therapeutic-goods-artg.  

6 

 
 
 
 
                                           
Recall actions are grouped into the following three categories: 

 Recall - permanent removal of an affected device from supply or use in the market, 

 Recall for product correction - device repair, modification, adjustment or re-labelling,  

 Hazard alert - information issued to healthcare professionals about problems occurred 

to implanted device or biological product and advice about patients' management. 

Recall  actions  are  classified  based  on  the  potential  risk  posed  by  the  deficiency  to 
patients/consumers according to the following three classes: 

 Class  I  recall  -  product  deficiency  is  potentially  life-threatening  or  could  cause  a 

serious risk to health, 

 Class II recall - product deficiency could cause illness, injury or result in mistreatment, 

 Class  III  recall  -  product  deficiency  may  not  pose  a  significant  hazard  to  health,  but 

other reasons could justify actions (e.g. quality related issues). 

A  summary  of  recent  recall  actions,  from  1  July  2012,  are  contained  in  the  System  for 
Australian Recall Actions (SARA) database.  

Alerts 

Alerts explain the outcome of an investigation, including recommendations for consumers 
and  health  professionals,  a  change  to  the  availability  of  a  product,  or  advise  about 
detection  of  counterfeit  or  illegal  products.  The  safety  information  section  of  the  TGA 
website contains all alerts issued since 1998.  

Early warning system  

This Early Warning System provides current and historical information on safety concerns 
identified by the TGA vigilance program: 

a.  Monitoring  communications  -  Early  communications  about  potential  safety  concerns 
which  have  not  been  fully  investigated  to  highlight  potential  safety  concerns  that  are 
identified  by  the  TGA.  It  is  to  be  noted  that,  following  a  monitoring  communication, 
consumers  should  not  stop  using  a  device,  health  professionals  should  not  change 
patient's treatment and not all of these concerns will result in actions, in particular when 
no  link  between  the  events  and  the  product  can  be  established.  This  section  contains 
communications since 2013. 

b. Alert communications - Alert communications are issued after a safety concern having 
been  investigated.  Alerts  contain  more  information  on  the  safety  concerns  and  provide 
advice  on  actions  that  may  need  to  be  taken  by  health  professionals  and  consumers. 
Safety  concerns  may  result  in  a  recall  action  (removal  of  the  product  or  corrective 
action), especially when a defective device is identified.  

Reporting problems with MD 

The  TGA's  Incident  Reporting  and  Investigation  Scheme  (IRIS8)  focuses  on  adverse 
events or incidents related to the use of medical devices and is based on investigations of 
adverse events or potential adverse events' reports from devices' users that can lead to 
actions  such  as  product  recalls,  safety  alerts,  product  improvement,  user  education  and 
compliance testing. Adverse events can be reported manually or following specific online 
forms by device users (clinicians, patients or their relatives) and/or MFRs/sponsors. Once 
introduced, the report will be investigated and discussed with the manufacturer/supplier 
and, if TGA considers that an action is needed, it may involve any of the following: 

 Recall - removal or corrective measure due to safety, performance or quality reasons, 

 Safety Alert - distribution of urgent information to the responsible for the device, 

 An alert or advisory notice - general information through the website. 

8 https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris.  

7 

 
 
 
                                           
Medical device incident reporting & investigation scheme (IRIS) 

IRIS is the tool used by TGA to manage the medical devices' reports of adverse events or 
problems as received from consumers, health professionals and industry.  

These reports received either manually or automatically, are then collected in a database 
after correctness and completeness being checked by TGA. 

Adverse events reports are classified on a risk basis and actions are taken following a risk 
assessment analysis. The actions can include: 

Informing  health  professionals  and  consumers  through  alerts  and  articles  on  the  TGA’s 
website and other publications, 

 Request for product improvement or for changes to IFU9 or labelling (e.g. warnings), 

 Product recall from the market, 

 Withdrawal of product market approval or restriction of use, 

 Request for additional user education, 

 Request for quality inspections, 

 No request for actions but regular monitoring for trends' identification. 

Safety information & education 

The "Safety information" section of the TGA webpage provides links to articles about the 
general  safety  of  medicines  and  medical  devices  and  allows  accessing  the  medical 
devices  Database  of  Adverse  Event  Notifications  (DAEN10)  database  which  provides 
information about adverse events related to medical devices in Australia.  

3.1.2  BRAZIL - Brazilian Health Surveillance Agency  

The  National  Health  Surveillance  Agency  (ANVISA11)  is  the  regulatory  agency  of  the 
Brazilian  Ministry  of  Health  which  has  as  its  main  goal  the  protection  and  promotion  of 
public  health.  To  this  aim,  ANVISA  conducts  vigilance  and  market  surveillance  activities 
in several areas such as drugs, food, cosmetics, and medical devices.  

In this respect, the ANVISA website includes two sections providing information on alerts 
(Alertas  sobre  produtos  para  a  saúde)  and  reports  on  health  products  (Informes  sobre 
produtos para saúde). 

It  is  to  be  noted  that,  with  the  exception  of  a  general  introduction  provided  in  English, 
the ANVISA website is in Portuguese only. 

3.1.3  CANADA - Health Canada 

Health  Canada  is  the  Federal  department  responsible  for  medical  devices  through  its 
Therapeutic Products Directorate12 (TPD) which is in charge of conducting the pre-market 
assessment  of  medical  devices'  safety,  effectiveness  and  quality  ensuring  as  well  post-
approval surveillance and quality systems in the manufacturing process.  

The  department  routinely  evaluates  Canadian adverse  event  reports  and,  in  case  safety 
issues are identified, takes appropriate actions such as distribution of new product safety 
information, recommendation of changes to the product's labelling or request for product 
removal from the market. 

9 Instructions for use. 
10 https://www.tga.gov.au/database-adverse-event-notifications-daen. 
11 http://portal .anvisa.gov.br/     
12 http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php.  

8 

 
 
 
                                           
Recalls and Safety Alerts Database 

In  addition,  the  Health  Canada's  Marketed  Health  Products  Directorate  (MHPD)  has 
developed  the  MedEffect  program  to  improve  the  safety,  effectiveness  and  access  to 
therapeutic  products  available.  Through  the  MedEffect  webpage  it  is  possible  to  have 
access to a link to the Recalls and Safety Alerts Database that provides access to recalls, 
advisories,  and  safety  alerts,  including  a  newsletter  with  information  about  adverse 
events.  

The  Recalls  and  Safety  Alerts  Database  includes  safety  alerts  and  recalls  of  different 
products  (food,  consumer  products,  vehicles  and  health  products),  however,  the 
database search engine allows conducting targeted searches specific to medical devices.  

Health Product Info Watch 

Among  the  different  sources  of  information  on  safety  related  problems,  it  is  to  be 
mentioned the Health Product Info Watch.  

It is a newsletter providing information on serious or unexpected side effects or adverse 
reactions suspected of being associated with health products, such as medical devices, to 
make people aware about safety issues with health products.  

The newsletter also alerts about signals related safety issues detected during reviews of 
suspected  adverse  reaction  cases,  which  are  reported  to  Health  Canada  through  the 
Canada Vigilance Program and the Mandatory Problem Reporting for Medical Devices.  

Canada Vigilance Adverse Reaction Database 

Since 1965, the Canada Vigilance Program collects and assesses reports of suspected 
adverse reactions to health products, including medical devices, which can be accessed 
through the Canada Vigilance Adverse Reaction Online Database. 

Summary Basis of Decision documents: Medical Devices 

The  Health  Canada  web  page  provides  access  to  the  Summary  Basis  of  Decision  SBD 
documents that explain why Health Canada authorized certain MDs and IVDs for sale in 
Canada.  

The  documents  include  regulatory,  safety,  effectiveness  and  quality  (manufacturing) 
considerations. 

3.1.4  CHINA - China Food and Drug Administration   

The China Food and Drug Administration (CFDA13) is the body responsible for the medical 
devices'  legislation  and  its  implementation,  including  market  surveillance  and  vigilance. 
In  order  to  carry  out  these  activities,  the  CFDA  is  structured  around  two  main 
departments dealing with medical devices: 

 Department of Registration, 

 Department of Supervision. 

Apart from a specific section on the laws and regulations regulating the medical devices, 
no other information is provided through the English version of the CFDA official website. 

On  the  opposite,  the  Chinese  version  appears  to  be  much  wider  and  could  potentially 
include data on alerts and recalls and other related safety measures.  

13 http://eng.sfda.gov.cn/WS03/CL0755/.  

9 

 
 
 
 
 
 
                                           
3.1.5  JAPAN - Pharmaceuticals and Medical Devices Agency  

The  Pharmaceuticals  and  Medical  Devices  Agency  (PMDA14)  is  the  Japanese  regulatory 
body responsible to ensure the safety, efficacy and quality of medical devices.  

The  official  website  of  the  PMDA  is  an important  source  of  information  on  recalls,  alerts 
and  other  safety  information  as  provided  by  the  Japanese  Marketing  Authorization 
Holders (MAH) when a product that they have marketed might cause a hazard associated 
with the use of medical devices. 

"Yellow Letter" and "Blue letter" 

This  section  of  the  PMDA  website  includes  the  communications  to  be  provided  by  the 
marketing  authorisation  holders  to  healthcare  professionals  by  means  of  the  so  called 
(Dear  Healthcare  Professional  Letters  of  Emergent  Safety 
"Yellow  Letter" 
Communications) and "Blue Letter" (Dear Healthcare Professional Letters of Rapid Safety 
Communications). 

These  letters  are  sent  in  cases  where  medical  devices  might  cause  hazards  to  patients, 
and  measures  need  to  be  taken,  including  recall,  suspension  of  sales,  and  information 
provision to prevent such hazards. 

The Yellow Letter contains emergent and important medical devices' safety information. 

The Blue Letter contains information that does not require emergent communications as 
Yellow Letter but should be promptly provided to alert healthcare professionals. 

It is to be noted that this information is not always provided in English. 

  MHLW Pharmaceuticals and Medical Devices Safety Information 

This  section  includes  safety  information  collected  by  the  Ministry  of  Health,  Labour  and 
Welfare  (MHLW)  to  facilitate  healthcare  professionals  when  using  medical  devices.The 
English  version  of  this  section  is  for  information  purpose  only  and,  in  order  to  have  a 
complete  overview  of  all  related  data  it  is  necessary  to  consult  the  Japanese  version, 
which also prevails in case of inconsistency with the information provided in English. 

Revisions of PRECAUTIONS 

This  section  includes  notices  to  revise  the  precautions  (warning,  contraindications  and 
adverse  reactions/events)  in  product  inserts.  The  notices  are  issued  MHLW  following  a 
recommendation by PMDA.  

It is to be noted that this information is available in English. 

Notification on self-check 

This  section  of  the  PMDA  website  contains  MHLW's  recommendations  addressed  to  the 
marketing  authorization  holder  to  conduct  self-check  relating  to  the  proper  use  of 
medical devices and, if needed, to adopt the needed revisions of the  package inserts or 
user manuals. The English version of this section is for information purpose only and, in 
order  to  consult  all  related  data  it  is  necessary  to  consult  the  Japanese  version,  which 
also prevails in case of inconsistency with the information provided in English. 

PMDA Medical Safety Information 

"PMDA Medical Safety Information" section of the PMDA website includes the information 
analysed in the previous paragraphs in a more understandable and widely disseminated 
way, including data on medical incident reports, reporting of similar events, cases leading 
to  notifications  for  revisions  to  package  inserts  and  recommendations  on  a  safe  use  of 
devices. 

It is to be noted that, although this information being available in English, the Japanese 
version prevails. 

14 http://www.pmda.go.jp/english/about-pmda/index.html.  

10 

 
 
 
 
                                           
3.1.6  SINGAPORE - Health Sciences Authority  

The  Singapore  Health  Sciences  Authority  (HSA)  is  structured  into  three  main  groups 
through  which  it  carries  out  its  mission.  In  particular,  the  Health  Products  Regulation 
Groups  manages  the  regulatory  framework  on  biomedical  products  which  is  responsible 
for  medical  devices  and  ensures  that  they  meet  appropriate  safety,  quality  and  efficacy 
standards.  All  information  regarding  medical  devices  registered  in  Singapore  for  use  in 
human being under the Health Product Act (Medical Device Regulation) are made publicly 
available online through the Singapore Medical Device Register (SMDR) database.  

HSA Vigilance/Post-market surveillance 

Field Safety Corrective Action  

As part of its vigilance post-market surveillance, HSA runs a system for the collection and 
share  of  Field  Safety  Corrective  Actions  (FSCA)  in  order  to  ensure  safety  of  medical 
devices suspected of being potentially harmful to users, due to nonconformity to quality, 
safety  and  performance  requirements.  To  this  aim,  all  information  on  FSCA  relating  to 
both  devices  manufactured  or  supplied  in  Singapore  and  to  devices  that,  although  not 
supplied  in  Singapore,  have  marketing  authorisation  or  have  been  imported  in  the 
country,  must  be  reported  to  HAS  according  to  specific  guidelines  and  forms.  These 
actions  can  include  the  removal  of  medical  devices  from  the  market  or  any  other 
corrective  action  on  devices  in  use.  Usually,  they  are  preceded  by  a  Field  Safety  Notice 
(FSN) of the product owner (alternatively the registrant or importer)  to inform operators 
and  users  regarding  risks  of  medical  devices  and  to  advise  about  the  measures  to  be 
taken in order to protect the health or the safety of patients, users or other persons. Also 
FSNs are made publicly available by HAS. 

Adverse Event Reporting 

In addition to FSCAs and FSNs, in order to ensure effective post-market surveillance and 
continued  safe  use  of  devices,  HSA  established  a  series  of  requirements  including 
reporting  of  adverse  events  from  healthcare  professionals,  mandatory  reporting  from 
manufacturers  and  dealers,  and  exchange  of  regulatory  information  with  other  medical 
device regulatory agencies. The report is to be submitted upon request of HSA. Specific 
guidelines  and  forms  are  established  by  HSA  for  each  of  the  different  kind  of  reporting. 
The  adverse  events  to  be  reported  are  classified  according  to  three  main  reporting 
criteria: 

1. An adverse event (or potential adverse event) has occurred, 

2. The device product is associated with the adverse event, 

3. The adverse event led to one of the following outcomes: 

 Serious threat to public health; 

 Death of a patient, user or other person; 

 Serious deterioration in state of health of patient, user or other person; 

 No death or serious injury occurred but the event might lead to death or serious  

 Injury of a patient, user or other person if the event recurs. 

The reporting timeline for adverse event reporting for dealers of device products are: 

 Within 48 hours for events that represents a serious threat to public health; 

 Within 10 days for events that has led to the death, or a serious deterioration in the  

 State of health, of a patient, a user of the medical device or any other person; 

 Within 30 days for events where a recurrence of which might lead to the death, or a  

 Serious deterioration in the state of health, of a patient, a user of the medical device 

or any other person 

11 

Once  the  reports  are  received,  HSA  reviews  them,  conducts  trend  analysis  and,  if 
unexpected  adverse  effects  are  identified  through  the  adverse  event  report,  this  can 
determine  changes  such  as  refinement  of  instruction  of  use  or  introduction  of  specific 
warnings.  In  case  a  hazard  is  considered  unacceptable,  the  device  could  also  be 
withdrawn from the market. 

Safety Information on medical devices 

The  safety  information  section  of  the  HSA  website  includes  a  series  of  information  on 
enforcement,  post-market  vigilance  and  compliance  activities  of  the  HSA  Authority,  as 
well as product safety information and recalls. 

As  specifically  regards  medical  devices,  under  this  section  it  is  possible  to  find  alerts, 
safety  messages  (Product  Safety  Alerts),  letters  to  healthcare  professionals  (Dear 
Healthcare  Professional  Letters),  recalls,  and  label  amendments  (Safety-related  Product 
Label Amendments). 

Medical Device Alerts 

As part of the HSA’s post-market safety surveillance programme for medical devices, this 
website provides information on medical device safety issues or events in order to raise 
awareness amongst healthcare professionals.  

In  addition,  it  aims  at  encouraging  reporting  of  adverse  events  by  physicians,  dentists 
and pharmacists. 

Product Safety Alerts 

This  website  provides  safety  messages  on  drugs,  medical  devices  and  related  health 
products which have major impact on public health and safety.  

Dear Healthcare Professional Letters 

This website provides the abstracts of the Dear Healthcare Professional Letters (DHCPL), 
which  are  advisory  letters  to  healthcare  professionals  by  HSA,  pharmaceuticals  and 
medical device companies. For more details regarding the DHCPL, it is important to refer 
to  the  Health  Professional  Portal  (HPP)  of  the  Ministry  of  Health  (MoH)  Alert  System 
(http://www.hpp.moh.gov.sg/).   

Safety-related Product Label Amendments 

This  website  provides  information  on  labelling  amendments  made  to  the  local  package 
inserts.  

Product Recalls    

This  website  provides  a  list  of  products  recalled  by  HSA  as  part  of  the  Product  Quality 
Surveillance  programme.  While  not  being  an  exhaustive  list  of  all  health  products  that 
could  be  the  subject  of  a  recall,  the  aim  of  this  information  is  to  alert  consumers  and 
healthcare professionals on some of the past recalls of health products in Singapore. 

3.1.7  RUSSIA  - Federal  Service  on  Surveillance  in  Healthcare  and  Social 

Development  

The Federal Service on Surveillance in Healthcare and Social Development (FSSHSD15) is 
the  body  of  the  Ministry  of  Health  and  Social  development  of  Russian  Federation 
responsible  for  the  implementation  of  the  Russian  legislation  on  medical  devices  and 
drugs.  

As regards alerts and  recalls and other safety  related information, although the Russian 
version  of  the  FSSHSD  website  appears  to  provide  this  information,  the  English  version 
only provides a general introduction to the different sections of the website.  

15 http://www.roszdravnadzor.ru/.  

12 

 
                                           
3.1.8  USA - Food and Drug Administration 

The  Food  and  Drug  Administration  (FDA16)  is  the  United  States'  national  regulatory 
agency responsible for the medical devices' safety. 

The  FDA  official  website  provides  different  kinds  of  information  relating  to  the  safety  of 
medical  devices  which  are  divided  in  two  main  areas:  i)  Medical  Device  Safety  and  ii) 
Medical Device Ban.  

The  first  area  includes  safety  communications  and  medical  device  recalls  while  the 
second  area  provides  information  on  post  market  surveillance  measures,  reporting  of 
medical devices' problems, adverse events and news. 

  Medical Device Safety 

Safety Communications  

In this section, the FDA publishes communications addressed to  consumers, health care 
providers,  businesses  and  all  other  potential  users  of  a  specific  device  to  alert  about  its 
malfunctioning  (e.g.  ineffective  delivery  system,  chemical  reactions)  or  about  the  risks 
relating to the use of the device and its characteristics.  

The alerts contain information that may determine actions impacting both treatment and 
diagnostic  choices  for  healthcare  professional  and  patient.  Therefore,  the  purposes  of 
these  communications  can  be  different  and  go  from  risk  awareness  rising  to  suggestion 
of better techniques for safe use or recommendation against its use of a product.  

The FDA issues such alerts after knowing about a problem with a device and this usually 
happens  because  FDA  receives  complaints  and  reports  on  adverse  events  or  problems 
with the use of a device. Subsequently, verification such as an inspection of the relevant 
company's facility is conducted by the FDA to verify the problem at stake. 

"MedWatch" is the FDA online tool giving access to the list of safety alerts.   

Medical Device Recalls  

This page of the FDA official website is dedicated to recalls of medical devices for which 
there is a reasonable chance that they could cause serious health problems or death. 

In  order  to  consult  recalls  relating  to  Class  I  and  some  Class  II  and  III  recalls  it  is 
possible to refer to the yearly lists of 2014, 2015 and 2016 whose the link is placed on 
the top left of the page. The list relating to 2013 is archived and the link is placed on the 
top right of the page. 

The full list of Class II and III recalls is made available by the CDRH Recalls Database.  

Adverse Event Reporting – Voluntary reporters  

MedWatch  also  allows  consumers  or  healthcare  professionals  voluntarily  reporting 
significant adverse events or product problems with medical products to FDA. 

In  particular,  through  MedWatch  consumers  and  healthcare  professionals  report  serious 
adverse event, product quality problem, product use error, or failure associated with the 
use of a medical device. Suspected counterfeit medical products can also be reported to 
FDA through MedWatch.  

Adverse events reporting system – Mandatory reporters 

Reporting  of  medical  adverse  events  is  made  mandatory  for  manufacturers,  importers 
and user facilities (e.g., hospitals, nursing homes) through the Medical Device Reporting 
regulation (21 CFR 803) which sets the following reporting requirements: 

16 http://www.fda.gov/default.htm.  

13 

 
 
                                           
• Manufacturers:   -  to  report  to  FDA  when  one  of  their  devices  may  have  caused  or  

contributed to a death or serious injury, 

-  to  report  to  FDA  when  one  of  their  devices  has  malfunctioned  and  
would  be  likely  to  cause  or  contribute  to  a  death  or  serious  injury  if  
the malfunction happened again; 

• Importers:  

-  to  report  to  FDA  and  the  manufacturer  when  one  of  their  devices  
may have caused or contributed to a death or serious injury, 

-  to  report  only  to  the  manufacturer  when  one  of  their  devices  has  
malfunctioned and would be likely to cause or contribute to a death or  
serious injury if the malfunction were to happen again; 

• User Facilities:   -  to  report  suspected  medical  device-related  death  to  both  the  FDA  

and the manufacturer,  

-  to  report  a  medical  device-related  serious  injury  only  to  the  
manufacturer, if known, otherwise to FDA. 

Although  not  being  obliged  to  do  it,  for  the  reporting  of  a  malfunction  or  problems  with 
medical devices user facilities can voluntarily use the MedWatch program to advise FDA.  

Manufacturers and User Facility Device Experience Database 

The  Manufacture  and  User  Facility  Device  Experience  (MAUDE)  database  hosts  the 
Medical  Device  Reports  (MDRs)  submitted  to  the  FDA  by  mandatory  reporters 
(manufacturers,  importers  and  device  user  facilities)  and  voluntary  reporters  such  as 
health care professionals, patients and consumers.  

The reports include a brief description of the incident, with information about the device, 
manufacturer  and  the  type  of  reporter.  These  reports,  which  refer  to  suspected  device-
associated  deaths,  serious  injuries  and  malfunctions,  are  used  by  the  FDA  to  monitor 
device  performance,  detect  potential  device-related  safety  issues,  and  contribute  to 
benefit-risk  assessments.  The  MAUDE  searchable  database  data  contains  the  last  10 
year's  data  and  allows  searching  the  FDA’s  Center  for  Devices  and  Radiological  Health 
(CDRH).  MAUDE  database  is  updated  monthly  and  the  search  page  reflects  the  date  of 
the most recent update. 

Although  being  very  useful  for  vigilance  purposes,  these  reports  present  several 
limitations  mainly  due  to  their  passive  nature  that  could  have  an  impact  on  the 
completeness,  accuracy,  MDR  data  alone  cannot  be  used  to  establish  rates  of  events 
evaluate a change in event rates over time or compare event rates between devices. The 
number  of  reports  cannot  be  interpreted  or  used  in isolation to  reach  conclusions  about 
the existence, severity, or frequency of problems associated with devices. In this respect, 
it should be taken into account that confirming whether a device caused a specific event 
can  be  difficult  if  based  only  on  information  provided  in  a  given  report  and  further 
verification of the circumstances surrounding the event or direct evaluation of the device 
could be needed.  

It is also to be considered that safety information for a reported medical device should be 
interpreted in the context of other available information when taking decisions. Moreover, 
certain types of information contained in the reports are protected from public disclosure 
under the Freedom of Information Act (FOIA). 

The FDA's Sentinel Initiative 

The  Sentinel  Initiative  is  an  FDA  ongoing  project  aimed  at  developing  an  electronic 
system,  complementing  existing  systems,  to  track  adverse  events  of  drugs,  biologics, 
and  medical  devices  on  the  market.  The  Sentinel  System  is  based  on  a  proactive 
approach,  also  known  as  active  surveillance,  through  which  the  FDA  actively  queries 
diverse automated healthcare data sources such as health record systems, administrative 
and insurance claims databases, and registries to evaluate possible safety issues quickly 
and securely. 

14 

  
 
  
  
  
 
  
  
  
   
   
The FDA will therefore be able to actively request information from the Sentinel System 
data  partners  (e.g.  academic  medical  centres  and  healthcare  systems)  when  a  safety 
question  arises  about  a  product.  This  proactive  initiative  complements  the  passive 
surveillance safety systems,  such as MAUDE,  currently in use by FDA, enabling the FDA 
to use existing electronic healthcare  

The Sentinel Initiative has been launched in 2008 and is now being tested through a pilot 
project called "Mini Sentinel". 

Medical Product Safety Network 

The  Medical  Product  Safety  Network  (MedSun)  is  an  adverse  event  reporting  program 
launched  in  2002  by  the  FDA  Centre  for  Devices  and  Radiological  Health  (CDRH) 
according to which a network of approximately 250 hospitals, nursing homes, and home 
health  facilities,  are  required  to  report  medical  device  problems  that  result  in  serious 
illness, injury, or death.  

MedSun  participants  are  also  encouraged  to  voluntarily  report  problems  with  devices, 
such as ‘close-calls,’ potential for harm, and other safety concerns. This database collects 
reports with a brief description of adverse events related to devices.  

As  part  of  the  MedSun  network  program,  it  is  also  to  be  mentioned  the  MedSun 
Newsletter  containing  information  on  newly  approved  devices,  links  to  FDA/CDRH 
databases and other information sources and update list of recalls and safety alerts. 

Medical Device Reporting database 

The  Medical  Device  Reporting  (MDR)  database  allows  you  to  search  the  CDRH's  (Centre 
for  Devices  and  Radiological  Health)  database  information  on  devices  which  may  have 
malfunctioned or caused a death or serious injury during the years 1992 through 1996.   

The  files  contain  reports  received  under  both  the  mandatory  Medical  Device  Reporting 
Program  from  1984  to  1996,  and  the  voluntary  reports  up  to  June  1993.  The  database 
currently contains over 600,000 reports.  

The reports include a description of the adverse event, and information about the device 
and manufacturer.  

It is no longer being updated, MDR after 1996 are included in MAUDE Database.  

  Medical Device Ban 

This section of the FDA website regards those medical devices for which a ban has been 
declared,  meaning  that  current  and  future  sales,  distribution,  and  manufacturing  of  the 
concerned devices are totally prohibited. 

The decision of the FDA to adopt such a measure, which is very rare (only one till now17), 
is based on available data and information proving that the device presents a substantial 
deception to patients or users about the benefits of the device (risk-benefit analysis), or 
an unreasonable and substantial risk of illness or injury, which cannot be corrected by a 
change in the labelling.  

In  order  to  determine  that  a  device  is  deceptive,  the  FDA  considers  whether  users  may 
be deceived or otherwise harmed by the device itself and the ban can be decided even in 
the absence of proof of illness or injury.  

Once a regulation to ban a device is published in the Federal Register, the product can no 
longer be legally marketed except under an approved investigational device exemption.  

17 Prosthetic hair fibers - Decision Effective from June 3, 1983.  

15 

                                           
3.2  Non-IMDRF members 

3.2.1  ARGENTINA  –  National  Administration  of  Drugs, Food  and  Medical 

Devices 

The National Administration of Drugs, Foods and Medical Devices (ANMAT) is the medical 
devices' regulatory authority of the Argentinian Ministry of Health.  

In  particular,  ANMAT  is  responsible  for  the  authorization,  registration,  standardization, 
and  vigilance  and  monitoring  of  devices  with  the  specific  purpose  of  ensuring  their 
compliance with efficacy, safety and quality requirements. 

Techno-vigilance Program 

As regards the vigilance area, the ANMAT developed a techno-vigilance program aimed to 
collect,  assess  and  manage  medical  devices'  adverse  events  and  carry  out  the  most 
appropriate corrective actions, as needed.  

This program achieves the early detection of adverse and/or unexpected events and also 
performance fails in the stage of widespread use.  

The techno-vigilance dedicated page of the ANMAT website includes a form used to notify 
adverse events or technical fails with MD.  

These  notifications  are  assessed  by  a  consultant  committee  composed  of  academic 
representatives, medical national associations and recognised professionals. 

When it is proved a MD causing an adverse event, appropriate actions to prevent, reduce 
and eliminate the risk for the health are taken.  

These  actions  can  be  modifications  in  the  register  of  the  product,  in  the  instructions  of 
use, manual of use, manufacturing, importing or  commercialization suspension and also 
register withdrawn. 

The  notified  adverse  events  are  also  included  into  a  non-publicly  available  database  to 
perform trend analysis.  

Alerts and Recalls 

With specific reference to medical devices' safety related information, the ANMAT website 
contains  a  section,  "Alerts  and  Recalls  of  Medical  Devices"  where  alerts  and  recalls  are 
publicly  available.  Up  to  date  two  alerts  are  published,  one  of  20  March  2015  and  the 
other of 5 February 2016. 

The  ANMAT  website  also  includes  a  section  on  products  for  which  a  "Prohibition  of  use 
and/or  marketing"  has  been 
the 
manufacturing/marketing process. 

irregularities 

issued  due 

regulatory 

to 

in 

Press and communication 

As  part  of  the  sources  of  information,  it  is  to  be  mentioned  the  section  on  "Press  and 
Communication"  which  includes  recent  safety  notices,  alerts,  articles  on  safety  issues, 
technical information documents and scientific publications. 

3.2.2  MEXICO  –  Federal  Commission  for  the  Protection  against  Sanitary 

Risks  

The  Federal  Commission  for  the  Protection  against  Sanitary  Risks  (COFEPRIS)  is  the 
Mexican  body  responsible  for  the  protection  of  the  population  against  sanitary  risks, 
through sanitary regulation, control and promotion.  

In  the  medical  devices  field,  the  COFEPRIS  is  in  charge  of  ensuring  high  quality, 
effectiveness and safety of these products. 

16 

 
 
Alerts 

As  regards  the  sources  of  information  on  alerts  or  other  safety  related  information  on 
medical devices, the COFEPRIS website includes a webpage  dedicated to alerts covering 
tobacco,  health  services,  food  and  dietary  supplements,  drugs  and  health  consumable 
goods and other products and services.  

No specific section on medical devices is available.  

The COFEPRIS website provides information in Spanish only. 

3.2.3  NIGERIA  -  National  Agency  for  Food  and  Drug  Administration  and 

Control  

The  National  Agency  for  Food  and  Drug  Administration  and  Control  (NAFDAC)  is  the 
Nigerian Agency responsible for regulating and controlling the manufacture, importation, 
exportation,  advertisement,  distribution,  sale  and  use  of  food,  drugs,  cosmetics, 
chemicals and packaged water, and medical devices.  

Alerts and recalls 

A  specific  section  of  the  NAFDAC  website  is  dedicated  to  medical  devices  where  it  is 
possible  to  consult  recently  published  alerts  and  recalls  of  medical  devices.  At  the 
moment, only 4 measures taken from 13 to 17 May 2016 are visible. 

However,  under  the  section  "Publications"  of  the  website  it  is  possible  to  consult  the 
archive  where  alerts  and  recalls  relating  to  medical  devices  are  available  along  with 
drugs, cosmetics, food and other products.  

All information is provided in English. 

3.2.4  SAUDI ARABIA - Saudi Food and Drug Authority 

The Saudi Food & Drug Authority (SFDA) is the Saudi regulatory authority for food, drugs 
and medical devices. The main purpose of the SFDA is to regulate, oversee, and control 
food, drug, medical devices, as well as to set mandatory standard specifications thereof, 
whether they are imported or locally manufactured.  

As specifically regards medical devices, the SFDA set up the National Centre for Medical 
Devices  Reporting  (NCMDR)  to  ensure  safety  of  medical  devices  and  to  protect  patients 
and public from deficient products.  

The  NCMDR  maintains  an  up-to-date  database  of  medical-devices  recalls  and  adverse 
event  reports  and  supports  hospitals  and  healthcare  providers  to  take  appropriate 
corrective actions, whereas needed.  

The National Centre for Medical Devices Reporting (NCMDRC) 

NCMDRC treats reports and feedback information about both malfunctions and suspected 
adverse  events  and  confirmed  recalls  from  hospitals  and  healthcare  facilities  all  around 
the Saudi Arabia Kingdom.  

Once  received,  these  reports  are  analysed  by  the  SFDA  in  collaboration  with 
manufacturers  and  suppliers  in  order  to  identify  the  best  action  to  be  taken  in  view  of 
ensuring that the concerned product performs safely. 

The centre also collects Fields Safety Notices (FSNs) and recalls from healthcare facilities 
as  well  as  manufacturers  as  published  by  both  the  SFDA  and  other  MD  Competent 
Authorities  abroad  (UK-MHRA,  US-FDA,  DE-BfArM,  IE-HPRA,  Hong  Kong-MDCO,  EU 
National Competent Authority Reports-NCARs, CH-Swissmedic and AUS-TGA). 

17 

 
 
 
 
3.2.5  SOUTH AFRICA – National Department of Health  

The Department of Health of the South African government is the department in charge 
of health issues with a view to improve the healthcare delivery system. 

As  specifically  regards  medical  devices,  currently  only  electronic  medical  devices  are 
regulated, therefore, medical devices other than these are not regulated in South Africa.  

No  publicly  available  information  with  regard  to  the  safety  of  MDs  and  In  Vitro 
Diagnostics (IVDs) relevant for the European market has been found.   

Table 1. Sources of alerts, recalls & other relevant info (IMDRF members) 

Member 

Alerts 

Recalls 

Australia 

Alerts 

System for Australian Recall 
Actions 

SARA 

Brazil 

http://portal.anvisa.gov.br
/alertas2 

Canada 

Recalls and Safety Alerts 
Database 

Recalls and Safety Alerts 
Database 

Other safety related 
information 

Incident Reporting and 
Investigation Scheme 

IRIS 

Database of Adverse Event 
Notifications 

DAEN 

Early Warning System 

Informes sobre produtos para 
saúde 

Health Product Info Watch 

Canada Vigilance Adverse 
Reaction Online Database 

China 

N/A 

N/A 

N/A 

"Yellow Letter" 

"Yellow Letter" 

Japan 

"Blue Letter" 

Notices to revise the   
precautions 

MHLW Pharmaceuticals and MD 
Safety Information (JN only) 

Russia 

N/A 

N/A 

N/A 

Medical Device Alerts 

Singapore 

Product Recalls 

Product Safety Alerts 

USA 

MedWatch - Safety 
Information and Adverse 
Event Reporting Program 

CDRH – Medical Device 
Recalls 

Dear Healthcare Professional 
Letters 

Safety-related Product Label 
Amendments 

MAUDE Manufacture and User 
Facility Device Experience  

MedSun - Medical Product 
Safety Network 

Source: JRC MDTF, 2017. 

18 

 
 
 
 
 
 
 
 
 
 
 
Table 2. Sources of alerts, recalls & other relevant info (Non-IMDRF members) 

Member 

Alerts 

Recalls 

Other safety related 
information 

Argentina 

Alerts and Recalls of 
Medical Devices 

Alerts and Recalls of Medical 
Devices 

Techno-vigilance program 

Mexico 

Alertas sanitaria 

Nigeria 

Recalls & Alerts Published 
by NAFDAC 

Recalls & Alerts Published by 
NAFDAC 

S. Arabia 

NCMDRC – The National 
Centre for MD Reporting 

NCMDRC – The National 
Centre for MD Reporting 

NCMDRC – The National Centre 
for MD Reporting 

S. Africa 

N/A 

N/A 

N/A 

Source: JRC MDTF, 2017. 

3.3  Quantitative analysis of extra-EU alerts and recalls  

Quantitative analysis  

In December 2013, in an attempt to provide a quantitative overview about the amount of 
alerts  and  recalls  expected  to  be  identified  on  a  daily  basis  outside  the  EU,  the  JRC 
conducted  a  preliminary  monitoring  of  the  alerts  and  recalls  occurred  from  January  to 
November  2013  in  the  thirteen  regions  that  were  made  the  subject  of  this  report 
(Chapter  2.2),  with  the  exception  of  Singapore  which  became  official  member  of  the 
IMDRF on 15 September 201618. 

It  is  to  be  noted  that  Japan  and  Russia  are  not  included  in  this  activity  because  the 
information  provided  through  their  websites  is in  national language  only  and  translation 
was not available at the time of the analysis.  

The main objective of the JRC was to provide an overview about the average number of 
safety  measures  (alerts/recalls)  potentially  affecting  the  EU  and  for  which  the  presence 
on the European market would need to be verified.  

As showed in the table below (Table 4), on average, 23 alerts and/or recalls are expected 
to be daily published through the official webpages of the relevant regulators.  

The  analysis  also  suggested  that,  in  order  for  a  daily  monitoring  system  of  extra  EU 
alerts  and  recalls  to  be  effective,  the  following  issues  will  need  to  be  preliminarily 
ascertained: 

 The product is a medical device or an in vitro diagnostics, 

 The product bears a "Conformité Européenne" (CE) marking, 

 The device is placed on the EU market, 

 The specific issue impacts the EU, 

 The device is available for sale in the EU, 

 The real manufacturer/authorised representative and its legal base in the EU, 

 Real nature of the action taken (alert, recall or other). 

18 http://www.imdrf.org/docs/imdrf/final/meetings/imdrf-meet-160913-brazil-meeting-outcome-statement.pdf.  

19 

 
 
 
 
 
 
 
                                           
Table 3. Quantitative analysis of alerts/recalls occurring outside the EU 

Analysis of the EU relevance  

In  a  second  phase,  through  a  search  into  the  European  databank  on  Medical  Devices 
(EUDAMED),  the  JRC  verified  whether  the  affected  devices  analysed  were  distributed  in 
one or more countries within the EU market.  

In  order  to  ensure  the  coverage  of  the  different  categories  of  devices  existing  on  the 
market, the analysis took into account alerts and recalls relating to ten device types: 

Configurable MD systems 

1.  Recall - PET Discovery 600 and Discovery 690 Systems - S.A 

2.  Recall - Home Choice dialysis equipment - BRA 

3.  Recall - Autopulse resuscitation system model 100 - BRA 

4.  Recall - iPlan RT Dose - BRA 

5.  Recall - Puritan Bennett 840 Series Ventilator - US 

6.  Recall - Imaging system software, CardiacVX and CardiacVX Flow - S.A 

Implantable MD 

7.  Alert - Journey Bi-Cruciate Stabil. (BCS) knee repl. system - femoral imp. - AUS 

8.  Recall - Segmental System, Polyethylene Inserts - CAN 

9.  Alert - Medtronic Mosaic Porcine Aortic Bioprosthesis - AUS 

Active Implantable MD 

10. Alert - Implantable infusion pumps - US 

11. Recall - Animas 2020 Infusion Insulin Pumps - US 

MD for dentistry 

12. Recall - SEAC Dental System - Model 2020 - CAN 

13. Recall - Toothbrush for kids - US 

MD for ophthalmology 

14. Recall - ACUVUE ADVANCE Brand Contact Lenses - US 

20 

BrazilCanadaMexicoNigeriaSaudi ArabiaMonthRecallsAlertsRecallsAlerts/recallsMedical & Radiation Emitting Device RecallsMedwatch Alerts AlertsRecalls & Safety AlertsRecallsAllAverage per day by month         (22 wd) Jan39175412532001126912Feb4716741322800629413Mar4935861243000256347Apr6651010316042001339918May62215792513700745320Jun42376917724001385239Jul59117852133200941619Aug52513572773300544220Sep3737661692800285839Oct54522421123300227012Nov5841063033400642119DecTotal 5654310972120433530076391023AustraliaUnited States  
 
 
 
 
 
 
 
 
 
 
 
 
MD for respiratory/anaesthesia 

15. Recall - Compressor Mini - S.A. 

16. Recall - Puritan Bennett™ 840 ventilator - BRA 

17. Recall - Fabius Series Anesthesia Machines - US 

In vitro diagnostic devices 

18. Recall - Citrate Activated Partial Thromboplastin Time Cuvettes - AUS 

19. Alert - TRUEtrack blood glucose meters - CAN 

20. Recall - ABL90 FLEX Analyser - AUS 

21. Recall - Vitros Immunodiagn. Prod.s Anti-HBS Calibrator and Reagent Pack - CAN 

Surgical instruments 

22. Alert - Endo GIA Articulating™ 60-3.5mm Surgical Stapler Reloads - CAN 

23. Alert - 27G Sterile Cannula Packed in Amvisc and Amvisc Plus - US 

24. Recall - Hi- Torque connect guidewire - BRA 

25. Recall - Steris Fine Traction Device - CAN 

Single use/Sterile MD 

26. Recall - INSUPEN- Sensitive Needles - BRA 

27. Recall - Vented Spike with Clearlink - AUS 

28. Recall - Femoral Arterial and Venous Cannulae - S.A. 

Hospital equipment 

29. Recall - S3 and Secure II Medical/Surgical Beds. - S.A. 

30. Alert - Liko overhead lifts ceiling-mounted rail systems – AUS 

The  analysis  focused  on  the  alerts  and  recalls  occurred  in  five  of  the  thirteen  countries 
that  were  made  the  subject  of  the  current  report  (See  Chapter  2.2)  and  takes  into 
consideration  30  safety  measures  (7  alerts  /  23  recalls)  adopted  in  the  time  frame  May 
2013-January 2014. 

The  five  selected  countries  (Australia,  Brazil,  Canada,  Saudi  Arabia  and  United  States) 
were  chosen  because  their  official  webpages  provide  relevant  information  on  alerts  and 
recalls  either  in  English  or  in  a  language  easily  understandable  and  translatable  by  the 
JRC staff working on this project. 

As  the  summary  table  below  shows  (Table  4),  the  analysis  of  the  30  safety  measures 
carried  out  through  EUDAMED  provided  information  relevant  to  the  EU,  with  different 
degrees of approximation, in 18 cases.  

This information helped identifying the Competent Authority/s that might be affected by 
the concerned safety issues occurred outside the EU. 

It is to be noted that, although the devices found in EUDAMED seem to be corresponding 
to  the  products  affected  by  the  alerts/recalls  issued  outside  the  EU,  the  information 
provided by EUDAMED is, in most cases, insufficient to ensure that they are exactly the 
same products. 

This question, along with the general issue regarding the development of an automated 
system  for  early  detection  of  signals  outside  the  EU,  will  be  further  explored  under 
section 2.5.    

21 

 
 
Table 4. Analysis of the EU relevance  

Country 

Alert 

Recall 

MD type 

Related NCAR 

Findings 

European relevance 

Australia 
6/1/2014 

Journey Bi-Cruciate 
Stabilised (BCS) knee 
replacement system – 
femoral implant 

Implantable MD 

INC-DE-09-11-000109 

(This NCAR does not 
seem to refer to the 
same problem) 

DVC-DE-09-11-000036 

This entry seems to be related to the concerned device 

DE, BE, NL  

(Source: DVC module) 

Liko overhead lifts 
ceiling-mounted rail 
systems 

Australia 
6/1/2014 

Australia 
23/1/2014 

Australia 
24/12/2013 

Hospital equipment 

No entry relevant to the concerned device  

Vented Spike with 
Clearlink 

Single use MD 

No entry relevant to the concerned device  

Citrate Activated 
Partial 
Thromboplastin Time 
Cuvettes  

IVD 

No entry relevant to the concerned device  

1 

2 

3 

4 

5 

Australia 
6/11/2013 

ABL90 FLEX Analyser 

IVD 

6 

7 

Australia 
28/1/2014 

Medtronic Mosaic 
Porcine Aortic 
Bioprosthesis 

Implantable MD 

Brazil 
18/6/2013 

iPlan RT Dose 

Configurable MD system 

INC-DK-12-07-000009 

(This NCAR does not 
seem to refer to the 
same problem) 

INC-DK-13-11-000013  

(This NCAR seems to 
refer to the same 
problem) 

INC-DE-13-01-000104  

(This NCAR does not 
seem to refer to the 

22 

DVC-DK-11-02-000005 

AT, BE, CZ, DE, DK, ES, FI, FR, 
UK, IT, NL, NO, PL, SE, CH 

This entry (and possibly others) seems to be related to the 
concerned device 

(Source: DVC module) 

DVC-NL-12-01-000250 

This entry seems to be related to the concerned device 

DVC-DE-12-12-005534 

This entry seems to be related to the concerned device 

NL 

DE 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
8 

9 

Brazil 
02/12/2013 

Brazil 
05/12/2013 

INSUPEN- Sensitive 
Needles 

Single use MD 

No entry relevant to this device 

same problem) 

Puritan Bennett™ 840 
ventilator 

MD for 
respiratory/anaesthesia 

INC-IE-14-01-000005 

DVC-IE-14-01-000022 

This entry seems to be related to the concerned device  

10 

Brazil 
04/11/2013 

HomeChoice dialysis 
equipment 

Configurable MD system 

11 

Brazil 
08/11/2013 

Autopulse 
resuscitation system 
model 100 

Configurable MD system 

12 

Brazil 
11/12/2013 

Hi- Torque connect 
guidewire 

Surgical instrument 

13 

14 

15 

Canada 
6/1/2014 

SEAC Dental System – 
Model 2020 

MD for dentistry 

Canada 
22/5/2013 

Endo GIA Articulating™ 
60-3.5mm Surgical 
Stapler Reloads 

Surgical instrument 

Canada 
14/1/2014 

TRUEtrack blood glucose 
meters 

IVD 

AT, BE, BU, CY, CZ, ES, FI, FR, 
DE, GR, IE, IT, LV, LI, NL, PL, PT, 
RO, SL, SK, CH, TU, UK 

(Source: DVC module) 

AT, BE, BU, CY, CZ, DK, ET, DE, 
ES, FI, FR, GR, HU, IE, IT, LV, LI, 
MT, NL, NO, PL, PT, RO, SL, SK, 
SE, CH, TU, UK 

(Source: NCAR module) 

INC-CH-13-01-000008 
INC-CH-13-11-000106 

(These NCARs seem to 
refer to the same 
problem) 

DVC-CH-13-01-000034 
DVC-CH-13-01-000035 
DVC-CH-13-11-000359 
DVC-CH-13-05-000151 
DVC-CH-13-05-000150 

These entries seem to be related to the concerned device  

CRF-DE-12-06-001467  
CRF-DE-12-06-003910  
CRF-DE-12-06-000976 

These entries seem to be related to the concerned device  

DVC-IE-13-04-000140  
DVC-IE-13-10-000547  
DVC-IE-13-10-000527 

These entries seem to be related to the concerned device 

No entry relevant to this device 

DVC-AT-13-05-000242 

This entry seems to be related to the concerned device 

DVC-BE-11-10-000207  
DVC-BE-11-10-000208 
DVC-BE-11-10-000206 

DE 

IE 

DE 

BE 

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16 

Canada 
27/12/2013 

17 

Canada 
10/7/2013 

18 

Canada 
25/10/2013 

Segmental System, 
Polyethylene Inserts 

Implantable MD 

Steris Fine Traction 
Device 

Surgical instrument 

Vitros 
Immunodiagnostic 
Products Anti-HBS 
Calibrator and 
Reagent Pack 

IVD 

These entries seem to be related to the concerned device 

No entry relevant to this device  

DVC-GB-13-03-006385  
DVC-GB-09-11-011711 

UK 

These entries seems to be related to the concerned device 

DVC-GB-09-11-002278  
DVC-GB-09-11-011246 
DVC-GB-09-11-002280 

UK, AT, BE, CZ, DE, DK, ET, ES, 
FI, FR, UK, GR, HU, IT, LI, NO, 
PL, PT, SE, SL 

These entries (and possibly others) seem to refer to the 
concerned device 

(Source: DVC module) 

19 

Saudi Arabia 
9/1/2014 

PET Discovery 600 and 
Discovery 690 Systems 

Configurable MD system 

INC-FR-13-12-000031 

(This NCAR seems to 
refer to the same 
problem) 

DVC-FR-13-12-000067 

This entry seems to be related to the concerned device 

FR 
AT, BE, KR, CZ, DK, FI, DE, IT, 
NO, PL, RO, ES, CH, UK 

(Source: NCAR module) 

20 

21 

Saudi Arabia 
17/12/2013 

Saudi Arabia 
2/1/2014 

22 

Saudi Arabia 
26/12/2013 

23 

Saudi Arabia 

24 

United States 
20/1/2014 

Compressor Mini  

MD for 
respiratory/anaesthesia 

S3 and Secure II 
Medical/Surgical Beds. 

Hospital Equipment 

Femoral Arterial and 
Venous Cannulae 

Sterile/Single use MD 

No entry relevant to this device  

No entry relevant to this device  

DVC-DE-12-06-002826 

This entry seems to be related to the concerned device 

DE 

Imaging system 
software, CardiacVX 
and CardiacVX Flow 

Configurable MD system 

No entry relevant to this device  

Toothbrush for kids 

MD for dentistry 

No entry relevant to this device 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25 

United States 
28/6/2013 

Implantable infusion 
pumps 

Active implantable MD 

No entry relevant to this device 

26 

United States 
17/5/2013 

ACUVUE ADVANCE 
Brand Contact Lenses 

MD for ophthalmology 

ACT-GB-11-10-000060 (AR) 

No entry relevant to this device  
(Distribution in EU is indicated in the recall) 

AT, BE, DK, FR, DE, HU, IE, IT, 
LU, NL, PT, NO, SL, ES, SE, UK 

(Source: FDA Recall) 

27 

United States 
10/1/2014 

Puritan Bennett 840 
Series Ventilator  

Configurable MD system 

INC-IE-14-01-000005 

DVC-IE-14-01-000022 

This entry seems to be related to the concerned device  

AT, BE, BU, CY, CZ, ES, FI, FR, 
DE, GR, IE, IT, LV, LI, NL, PL, PT, 
RO, SL, SK, CH, TU, UK 

(Source: NCAR module) 

AT, BE, CY, CZ, DE, ES, FR, HU, 
IE, IT, MT, NL, NO, PT, SE, SL 

(Source: DVC module) 

DVC-GB-09-11-000031 

This entry seems to be related to the concerned device  

No entry relevant to this device 

DVC-DE-13-09-003922 

This entry seems to be related to the concerned device 

DE 

28 

United States 
23/01/2013 

27G Sterile Cannula 
Packed in Amvisc and 
Amvisc Plus 

Surgical instrument 

29 

United States 
4/5/2013 

30 

United States 
14/8/2013 

Animas 2020 Infusion 
Insulin Pumps 

Active implantable MD 

Fabius Series 
Anesthesia Machines 

MD for 
respiratory/anaesthesia 

INC-GB-09-11-000071  

(This NCAR seems to 
refer to the same 
problem) 

INC-DE-13-09-000437 

(This NCAR seems to 
refer to the same 
problem) 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.4  Compilation  of  recalls  and  alerts  occurring  over  a  six  week 

period 

As a completion of the quantitative analysis carried out in December 2013 and described 
under  paragraph  3.3  of  this  report,  in  July  2016  the  JRC  conducted  a  scoping  exercise 
collecting available recalls and alerts made available by  selected non EU regulators from 
the 2nd of May 2016 to the 12th of June 2016 (6 weeks). 

For practical reasons, this exercise takes into account only the four regulators (US FDA, 
Health  Canada,  TGA  Australia  and  Saudi  Arabia  SFDA)  of  which  the  official  websites 
provide comparable information in English. 

This  activity  aims  to  provide  a  realistic  picture  regarding  the  nature  of  information  that 
can be expected through a regular monitoring of the sources  made available by non EU 
authorities. 

In  this  respect,  the  scoping  exercise  shows  which  device  types  are  mainly  affected  by 
alerts  and  recalls,  gives  indications  about  the  most  frequent  problems  encountered  and 
actions undertaken, and allows to compare all data in view of possible trending analysis. 

Moreover,  US  FDA  website  also  provides  information  about  the  countries  (including  EU 
MS) where an alert or recall has occurred. 

This  information  allows  appreciating  the  amount  and  kind  of  actions  that  would  be 
needed,  on  a  daily  basis,  to  properly  react  to  the  relevant  information  coming  from 
outside Europe.  

Nevertheless,  the  distribution  list  provided  by  the  FDA  authority  only  concerns  those 
products for which an alert or recall has been taken in the United States.  

Therefore,  in  order  to  be  able  to  ascertain  whether  the  products  affected  by  an  alert  or 
recall in all the countries (other than US) have been placed on the European territory, the 
EU competent authorities would need to explore and possibly identify additional methods 
or ways, such as systematic check into EUDAMED.  

The figures below provide a summary of the main findings relating to the collected data: 

 83 alerts/recalls per week (12 per day), on average, 

 10 Alerts,  

 486 Recalls, 

 201 alerts and recalls relevant for the EU, 

 42 IVDs and 454 non IVDs affected. 

Full information regarding the data collected through the scoping exercise is available in 
the table attached to this document (See Supplementary material). 

This table will serve as a basis for the EU CAs to further explore the actual usefulness of 
the analysed information, the most appropriate way to take advantage of it and possible 
technical  solutions  supporting  its  effective  management  for  prompt  reaction  to/early 
detection of safety problems in the EU.  

26 

 
 
 
 
3.5  IT  tools  for  automated  collection  and  analysis  of  alerts  and 

recalls 

The  large  amount  of  data  on  alerts  and  recalls  that  are  expected  to  be  published  on  a 
daily basis shows that they cannot be treated manually due to excessive workload. 

Conversely, an automated system for collection and analysis of this information would be 
ideal to support prompt and accurate reaction to safety issues. 

In  particular,  a  series  of  IT  tools  is  needed  to  ensure  that  the  relevant  information  is 
appropriately collected, checked, stored and translated. 

Therefore,  it  appears  of  utmost  importance  to  start  working  on  the  development  of  key 
IT tools serving for: 

 Centralised collection of the information, 

 Targeted data mining throughout the identified sources/websites, 

 Appropriate entity check, 

 Automatic translation into English of retrieved alerts and recalls, 

 Effective  display  of  all  relevant  information  (i.e.  through  a  dedicated  webpage),  e.g. 

on a weekly basis and including an effective archiving function. 

The figure below (Fig. 1) shows a schematic depiction of the IT infrastructure that would 
potentially support automated collection and analysis of extra EU alerts and recalls. 

Figure 1. Potential IT infrastructure for automated collection & analysis of data  

27 

Step 1:Access websitesStep 2:Extractrelevant informationWebsites of international competent authoritiesWebsiteStep 4: Display informationJRC's Europe Media Monitor (EMM)Step 3: Collect, translate, categorise, entity-check  
 
 
 
3.5.1  DG JRC's translation tool 

In  order  to  ensure  an  effective  use  of  the  collected  data  on  alerts  and  recalls,  it  is 
important that the relevant information, as provided through the analysed sources (See 
Chapter  3),  is  appropriately  translated  from  the  local  languages  to  English.  In  this 
respect, the JRC identified the "Optima News Translation System" (ONTS) as a potentially 
ideal solution.  

The  "Optima  News  Translation  System"  (ONTS)  is  an  application  embedded  into  the 
Europe Media Monitor19 (EMM) system and was developed in-house by researchers of the 
JRC's  Directorate  I  "Competences".  Based  on  the  open  source  software  MOSES20,  the 
ONTS  translation  engine  translates  news  from  16  languages21  into  English  using 
statistical methods and large amounts  of data to identify the correct  translation of each 
phrase and to link them together in a comprehensive English sentence.  

Although acting on a unidirectional basis, the ONTS system is able to cover a very wide 
range of languages (See Fig. 2).  

Moreover, beside the languages already covered, the JRC's tool may, in the future, also 
allow translations from additional languages.  

This  would  be  particularly  relevant  for  languages  like  Russian  and  Japanese  referring  to 
two  countries  which  are  members  of  the  International  Medical  Device  Regulators  Forum 
(IMDRF)  and  represent  very  important  markets  of  medical  devices  and,  therefore,  are 
precious sources of safety information. 

Figure 2. JRC's ONTS translation system  

from 

around 

internet  news  websites 

19  EMM  is  a  live  media  monitoring  system  which  gathers  around  150,000  news  articles  every  day  from  over 
languages. 
3750 
https://ec.europa.eu/jrc/en/scientific-tool/europe-media-monitor-newsbrief. 
20 Moses is a statistical machine translation system that allows automatically training translation models for any 
language pair. 
https://ec.europa.eu/jrc/en/scientific-tool/europe-media-monitor-newsbrief. 
21  De  (EMM  native  technology),  It  (EMM  native  technology),  Es  (EMM  native  technology),  Fr  (EMM  native 
technology),  Fa  (EMM  native technology),  Pt  (EMM  native  technology),  Cs  (EMM  native technology),  Sa  (EMM 
native technology), Pl (EMM  native technology), Ru (EMM  native technology), Sv (EMM native technology), Nl 
(EMM native technology), Lt (EMM native technology), Lv (EMM native technology), Ar (EMM native technology 
+ language weaver), Zh (EMM language weaver). 

over  62  different 

the  world 

in 

28 

JRC's Europe Media Monitor (EMM)PolishPersianLithuanianLatvianItalianGermanFrenchDutchDanishCzechChinese**Arabic*PortugueseSpanishRussianSwedishEnglishMOSESappOPTIMA NEWS TRANSLATION SYSTEM(ONTS)All other languages: EMM native technology*EMM native technology + language weaver**EMM language weaver 
                                           
4  Supplementary material 

The  supplementary  material  to  this  report  (electronic  form)  provides  a  compilation  of 
information relating to alerts and recalls occurred in Australia, Canada, United States and 
Saudi Arabia and published through the websites of their medical devices agencies from 
the 1st of May to the 11th of June (6 weeks). 

This  data  collection  covers  four  of  the  regulatory  authorities  (Australian  TGA,  Health 
Canada,  US  FDA,  Saudi  Arabian  SFDA)  included  in  the  analysis  under  chapter  3  of  this 
report mainly due to the fact that they provide information in English.  

The data collected regard the type of safety measures (alert or recall), the specific device 
concerned  (trade  product  name),  and  the  related  manufacturer,  the  description  of  the 
background/reason and of the actions recommended. 

Information about the worldwide distribution of products, which is particularly important 
in  order  to  appreciate  whether  a  safety  issue  concerns  the  Union  territory,  is  provided 
only by the US FDA. 

This information is not provided by any other regulatory authority, therefore, in order to 
check if an extra EU safety measure affects the Union territory, EUDAMED appears to be 
the most appropriate means.  

However,  due  to  the  gaps  and  shortcomings  of  the  current  EUDAMED  (See  EUDAMED 
Evaluation  Report22),  this  would  be  really  effective  only  once  the  future  European 
centralised databank will be fully operational.  

In this respect, a manual searching test conducted by JRC in 2013 (See paragraph 3.3) 
showed  that,  in  spite  of  the  workload  needed  to  search  information  into  the  current 
EUDAMED,  the  results  obtained  were  not  fully  satisfactory  mainly  due  to  lack  of 
information.  

For this reason, the Annex does not contain data related to EUDAMED research although 
this option is reflected, through an empty column, for consideration by the EU CAs.  

22 http://ec.europa.eu/DocsRoom/documents/12981/attachments/1/translations. 

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
5  Conclusions  

This  report  provides  key  information  on  additional  data  sources  on  alerts,  recalls  and 
other safety relevant information which have not been systematically used until now.  

The appropriate management of this information would therefore be  crucial for effective 
signal detection by regulators, both in the EU and worldwide.  

To this aim, starting from the review of the existing sources of information, the document 
gives input and suggestions towards: 

(1)  Improved data set,  
(2)  Appropriate technical tools,  
(3)  Automated ways for EU relevance verification and 
(4)  Practical working procedure for management of the information collected.  

i) Data sets and terminology 

The  report  shows  that  a  large  amount  of  extra  EU  data  on  alerts  and  recalls  and  other 
relevant safety information is available.  

Although  very  promising  in  view  of  the  data  richness,  the  possible  systematic  collection 
and  use  of  this  information  is  hampered  by  variations  in  terminology  used  by  the 
different regulators.  

In  particular,  it  has  been  noted  that  terms  are  not  always  used  to  identify  the  same 
concepts (e.g. “alert” is used also to identify a “recall” and vice versa).  

Alignment and harmonisation of this terminology would be supportive of the collection of 
this information but also its exchange and joint analysis by various regulators. 

Moreover,  the  way  how  data  are  presented  is  very  heterogeneous  and  fragmented, 
ranging  from  ad  hoc  and  complete  databases  (e.g.  on  alerts,  recalls  or  other  safety 
communications)  to  simple  lists  of  information  of  different  nature  (e.g.  alerts,  recalls, 
safety notices, etc…). 

These  divergences  could  represent  an  obstacle  for  effective  automated  collection  and 
analysis of data. 

Recommendations:  

(1) We  recommend  exploring  the  opportunity  for  an  international  clarification  and 
harmonisation  of  the  terminology  relating  to  safety  information  on  medical 
devices.  

(2) For this purpose, the issue could be brought to the attention of the IMDRF. 

ii) Technical tools 

The report outlines the main technical tools that would need to be developed in support 
of an effective management of the existing safety information.  

Indeed,  the  nature,  amount  and  way  how  the  safety  information  is  daily  published  and 
displayed through the analysed extra EU websites pose a series of technical issues.  

In this respect, the report suggests a potential IT infrastructure for automated collection 
and  analysis  of  data  which  highlights  the  main  tools  and  solutions  to  be  set  up  for 
identifying, collecting, checking, translating and displaying the relevant information. 

  Recommendations: 

  We  recommend  developing  an  integrated  IT  infrastructure  supporting  automated 

collection and preliminary analysis of data.  

  This  should  mainly  include  IT  programmes  allowing  for  entity  check  and  data 

mining, a webpage for displaying information and a translation tool. 

30 

 
 
 
iii) EU relevance verification 

A  -  The  report  shows  that,  in  order  to  ensure  effective  signal  detection,  it  will  be 
important  to  set  a  process  able  to  rapidly  determine  whether  a  recall  or  alert  occurred 
outside the EU is relevant for the Union market.  

B  -  In  addition,  it  is  important  to  highlight  that  relevance  does  not  necessarily  imply 
presence  of  the  concerned  product  on  the  Union  territory.  Indeed,  safety  actions 
regarding  products  not  on  the  EU  market  could  also  reveal  risks  and  support  early 
vigilance  "pattern  recognition"  (i.e.  correlations  between  use  of  devices  and  adverse 
health effects), they also need to be systematically identified and analysed. 

Recommendations:  

(1) We recommend using the future EUDAMED as the key tool to provide information 

about the presence of the product on the EU.  

(2) We  recommend  establishing  a  structured  dialogue  between  all  stakeholders  and 
CAs for the early detection of potential risks relating to products not placed on the 
EU. 

iv) Working procedure  

An  effective  management  of  the  existing  extra  EU  safety  information  would  require  a 
coordinated approach at European level to ensure full share and coordinated treatment of 
the available data.  

Recommendations: 

(1) We  recommend  setting  up  a  practical  procedure  for  the  systematic  management 

of alerts, recalls and other relevant safety information.  

(2) This procedure should allow for prompt analysis and coordinated reaction to safety 
problems affecting the EU territory and could be put in place by MS CAs and EC in 
the  framework  of  the  EU  Vigilance  Medical  Device  Expert  Group  (MDEG),  e.g. 
through its regular teleconferences.  

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References  

1.   JRC (2017) - "Survey on signal detection for monitoring adverse events with medical  

devices". 

2.   JRC  (2016)  -  "JRC  Strategic  Planning  Document  -  Enhancing  the  effectiveness  of  
   medical  device  incident  reporting;  Final  report  of  the  EU  pilot  on  the  manufacturer  

incident reporting form (MIR form)". 

3.  JRC  (2016)  -  "JRC  Strategic  Planning  Document  -  Integrating  globally  available 
safety information on medical technology into EU vigilance/market surveillance work 
streams".  

4.   JRC  (2016)  -  "JRC  Strategic  Planning  Document  -  Integrated  approaches  for  signal 
detection  and  trending  –  towards  a  conceptual  framework  for  identifying,  verifying 
and  acting  on  signals  combining  quantitative  and  qualitative  information."  In 
preparation 

5.   AUSTRALIA, Therapeutic Goods Administration (TGA) 

  https://www.tga.gov.au/  

6.   BRAZIL, National Health Surveillance Agency (ANVISA) 

    http://portal.anvisa.gov.br/  

7.   CANADA, Health Canada 

  http://www.hc-sc.gc.ca/index-eng.php    

8.   JAPAN, Pharmaceuticals and Medical Devices Agency (PMDA) 

    http://www.pmda.go.jp/english/index.html  

9.   RUSSIA, Federal Service on Surveillance in Healthcare and Social Development 

    http://www.roszdravnadzor.ru/en/  

10.  SINGAPORE, Health Sciences Authority 

    http://www.hsa.gov.sg/content/hsa/en.html  

11.  United States of America, Food and Drug Administration (FDA) 

  http://www.fda.gov/default.htm  

12.  Argentina, National Administration of Drugs, Food and Medical Devices (ANMAT) 

  http://www.anmat.gov.ar/principal.asp  

13.  MEXICO, Federal Commission for Protection against Sanitary Risks (COFEPRIS) 

    http://www.cofepris.gob.mx/Paginas/Inicio.aspx  

14.  NIGERIA, Agency for Food and Drug Administration and Control (NAFDAC) 

    http://www.nafdac.gov.ng/index.php  

32 

  
  
 
 
 
 
 
 
 
 
 
 
 
 
15.  SAUDI ARABIA, Saudi Food and Drug Authority (SFDA) 

  http://www.sfda.gov.sa/en/Pages/default.aspx  

16.  SOUTH AFRICA, Department of Health 

  http://www.health.gov.za/ 

17.  Application  Requirements  for  Participation  in  the  GHTF  National  Competent  Authority  
    Report Exchange Program (GHTF/SG2/ N38R19:2009)  

    http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n38r19-national- 

competent-authority-report-program-090701.pdf  

18.  IMDRF Work Item - A review of the NCAR system 

    http://www.imdrf.org/workitems/wi-ncarsystem.asp  

19. SANCO (2012) - Evaluation of the EUropean DAtabank on MEdical Devices 

    http://ec.europa.eu/DocsRoom/documents/12981/attachments/1/translations  

20.  Global  Harmonization  Task  Force  (2006)  -  "Medical  Devices  Post  Market  Surveillance:  
Devices"  
Event 
    Global 

for  Medical 

Reporting 

Adverse 

for 
(GHTF/SG2/N54R8:2006) 

Guidance 

http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n54r8-guidance-
adverse-events-061130.pdf 

33 

 
 
   
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
List of abbreviations and definitions  

ANMAT 
ANVISA 
ARTG  
AT 
BE 
BfArM 
BU 
CA 
CDRH 
CE 
CFDA 
CH 
COFEPRIS 
CY 
CZ  
DAEN 
DE 
DG 
DK 
DVC 
EMM 
EC 
ES 
EU 
EUDAMED 
FDA  
FI 
FR 
FOIA 
FSN 
FSSHSD 
GHTF 
GR 
GROW 
HPRA 
HSA 
HU 
IE 
IFU 
IMDRF 
IRIS 
IT 
IVD  
JRC 
KR 
LV 
LI 
MAUDE 
MDCO 
MDEG 
MDR 
MedSun 
MHLW 
MHPD 
MHRA 

National Administration of Drugs, Foods and Medical Devices (AR) 
Health Surveillance Agency (BR) 
 Australian Register for Therapeutic Goods 
Austria  
Belgium 
Federal Institute for Drugs and Medical Devices (DE) 
Bulgaria 
Competent Authority 
Center for Devices and Radiological Health (US) 
Conformité Européenne 
China Food and Drug Administration 
Switzerland 
Federal Commission for the Protection against Sanitary Risks (MX) 
Cyprus 
Czech Republic 
Database of Adverse Event Notifications (US) 
Germany 
Directorate-General 
Denmark 
Device 
Europe Media Monitor 
European Commission 
Spain 
European Union 
 European Databank on Medical Devices 
Food and Drug Administration (US) 
Finland 
France 
Freedom of Information Act (US) 
Field Safety Notice 
Federal Service on Surveillance in Healthcare and Social Development (RU) 
Global Harmonisation Task Force 
Greece 
Directorate-General Internal Market, Industry, Entrepreneurship and SMEs 
Health Products Regulatory Authority (IE) 
Health Sciences Authority (SG) 
Hungary 
Ireland 
Instructions for Use 
International Medical Device Regulators Forum 
Incident Reporting and Investigation Scheme (US) 
Italy 
In Vitro Diagnostic  
Joint Research Centre 
Croatia 
Latvia 
Lithuania 
Manufacturer and User Facility Device Experience (US) 
Medical Device Control Office (HK) 
Medical Devices Expert Group 
Medical Device Report 
Medical Product Safety Network (US) 
Ministry of Health, Labour and Welfare (JP) 
Marketed Health Products Directorate (CA) 
Medicines and Healthcare Products Regulatory Agency (UK) 

34 

 
MOSES 
MS 
MT 
NAFDAC 
NCAR 
NCMDR 
NL 
NO 
NOTIVISA 
ONTS 
PMDA 
PL 
PT 
RO 
SARA 
SBD 
SE 
SFDA 
SK 
SL 
SMDR 
SMEs 
TGA 
TPD 
TU 
UK 
US 

Major Open Systems Environment Standards 
Member State 
Malta 
National Agency for Food and Drug Administration and Control (NG) 
National Competent Authority Report 
National Centre for Medical Devices Reporting (SA) 
Netherlands 
Norway 
 Sistema de Notificações em Vigilância (BR) 
Optima News Translation System 
Pharmaceuticals and Medical Devices Agency (JP) 
Poland 
Portugal 
Romania 
System for Australian Recall Actions (AU) 
Summary Basis of Decision (CA) 
Sweden 
Saudi Food and Drug Authority 
Slovakia 
Slovenia 
Singapore Medical Device Register 
Small and medium-sized enterprises 
Therapeutic Goods Administration (AU) 
Therapeutic Products Directorate (CA) 
Turkey 
United Kingdom 
United States 

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
List of figures  

Figure 1. Potential IT infrastructure for automated collection & analysis of data 

Figure 2. JRC's ONTS translation system   

27 

28 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
List of tables  

Table 1. Sources of alerts, recalls & other relevant info (IMDRF members) 

Table 2. Sources of alerts, recalls & other relevant info (Non-IMDRF members) 

Table 3. Quantitative analysis of alerts/recalls occurring outside the EU 

Table 4. Analysis of the EU relevance 

18 

19 

20 

22 

37 

 
 
 
 
 
 
 
 
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doi:10.2760/006806 
ISBN 978-92-79-68182-0