26 Vigilance Control System-R5

QUALITY SYSTEM PROCEDURE
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SM/QSP/26-R5 Effective Date 01.06.2021
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TITLE VIGILANCE CONTROL SYSTEM
1.0 PURPOSE
The purpose of vigilance procedure is to improve the protection of health and safety of patients,
users and others by reducing the likelihood of reoccurrence of incidents related to the use of a
medical device.
2.0 SCOPE
This procedure describes the European system for the notification evaluation of INCIDENTs and
FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical
Device Vigilance System followed by SURGIMEDIC.
3.0 RESPONSIBILITY
Managing Director
Quality Manager
4.0 PROCEDURE
4.1 ROLE OF MANUFACTURER, EUROPEAN UNION REPRESENTATIVE, NOTIFIED BODIES, COMMISSION
AND USERS:
4.1.1 ROLE OF SURGIMEDIC (MANUFACTURER):

 SURGIMEDIC shall have a system for recording and reporting of incidents.
 SURGIMEDIC shall report to CAs (Relevant Competent Authorities) and Notified Body, when:
a) Any serious incident involving medical devices made available on the Union market,
except expected side-effects which are clearly documented in the product information
and quantified in the technical documentation and are subject to trend report.
b) Any field Safety Corrective Action (FSCA) in respect of devices made available on the
Union market, including any FSCA undertaken in a third country in relation to a device
which is also legally made available on the Union market, if the reason for the FSCA is
not limited to the device made available in the third country.
 SURGIMEDIC shall submit reports regarding medical device incidents that will be automatically
transmitted upon receipt, through electronic system to the CA of the Member State in which
the incident occurred.
 SURGIMEDIC shall submit field safety corrective actions that will be automatically transmitted
upon receipt via the electronic system to the competent authorities of the following Member
States:
(a) the Member States in which the field safety corrective action is being or is to be
This document contains confidential information that belongs to SURGIMEDIC. The document cannot be fully or
Warning partially copied without the prior written approval of the designated Directors of the organization. The content in
this document is intended only for the internal stakeholders.
Document Control, Approval and Issue Register maintained
by Management Representative.
MRD / F / 01 / R1 Page Number Page 1 of 18
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undertaken;
(b) the Member State in which the manufacturer has its registered place of business.
4.1.2 ROLE of EUROPEAN UNION REPRESENTATIVE
 Coordinate with SURGIMEDIC for communicating the FIELD SAFETY NOTICE to National
Competent Authority and Notified body.
 Coordinate with SURGIMEDIC for Initial INCIDENT (or Follow-up/Final) Report in case
SURGIMEDIC receives a USER report from a National Competent Authority.
 Coordinate with SURGIMEDIC for submitting the periodic report.
 Coordinate with SURGIMEDIC for submitting trend report.
4.1.3 ROLE OF NOTIFIED BODIES
 The performance of the Medical Device Vigilance System is supported by the Notified Body
activity in the following areas:
a) Assessment of vigilance procedures.
b) Audit of the implementation of the vigilance procedures, and link with other systems e.g.
Corrective and Preventive Action (CAPA), FSCA.
c) Assessment of the impact of vigilance issues on the certification granted.
d) Liaise with the National Competent Authority if required, e.g. specific
e) Investigations/ audits based on a request of the National Competent Authority
 The notified body shall, upon receipt of vigilance cases decide about the following options:
a) Not to take action on the basis that is the vigilance case is clearly not related to the
certification granted,
b) Observe SURGIMEDIC’s and Competent authority’s activities and the results of the
SURGIMEDIC’s investigation so as to determine whether the certification granted is at risk
or whether adequate corrective action has been taken,
c) Perform extraordinary surveillance measures, such as document reviews, short-notice or
unannounced audits and product testing, where it is likely that the certification granted is
at risk,
d) Increase the frequency of surveillance audits,
e) Review specific products or processes on the occasion of the surveillance audit of
SURGIMEDIC, or
f) Take any other relevant measure.
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4.1.4 ROLE OF THE COMMISSION
 The Commission shall ensure that appropriate coordination and cooperation is put into place
between the Competent Authorities of all Member States to allow the Medical Device
Vigilance System to deliver the high level of protection for the health and safety of patients
and USERs.
4.1.5 USERS ROLE WITHIN THE VIGILANCE SYSTEM
 There is no legal requirement within the directives obliging USERs to have an active role in the
Vigilance System. Yet for the successful operation of the vigilance system their involvement is
vital.
4.2 CRITERIA FOR INCIDENTS TO BE REPORTED BY SURGIMEDIC TO COMPETENT AUTHORITIES PER
MEDDEV 2.12/1 REV.8 & MDR 2017/745/EU
Primary responsibilities of SURGIMEDIC in regards to the European Medical Device Vigilance

System are to report incidents that meet specific criteria, of MEDDEV 2.12/1 Rev.8 which was
divided the criteria into three parts changed acc. to MDR 2017/745/EU to be Two Parts only as the
following:
4.2.1 An Incident Has Occurred
As per MEDDEV 2.12/1 Rev.8 criteria and MDR (EU) 2017/745, an incident has occurred when:
 Device malfunctions or deterioration affect the characteristics or performance of a device
made available on the market, occurred.
 Device use-error occurred due to ergonomic features.
 Any information supplied by SURGIMEDIC are not inadequate.
 Any undesirable side-effect happened.
 Tests performed via a device result in false conclusions
 Device promotes a patient reaction that was unexpected
 Device promotes a side effect that was unexpected
 A device has been destroyed
 A device has been abused or degraded
 Therapy that relies on the device has been offered inappropriately
 Medical device labels are not accurate.
4.2.2 The Device Contributed to the Cause of the Serious Incident
According to the MEDDEV 2.12/1 Rev.8 criteria and MDR (EU) 2017/745, a device contributed to a
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Serious Incident when any incident that directly or indirectly led, might have led or might lead to
any of the following:
 the death of a patient, user or other person.
 the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state
of heath.
 a serious public health threat, which means an event which could result in:
o imminent risk of death,
o serious deteriotion in a person’s state of health, or
o serious illness, that may require prompt remedial action, and that may cause
significant morbidity or mortality in humans, or that is unusual or unexpected for the
given place and time.
 Healthcare professionals opine that the device was related to the incident in question
 SURGIMEDIC opines (after appropriate investigation) that the device was related to the
incident in question.
 Incidents like the incident in question have occurred.
 Typology & modalities of serious incidents expected by implementing acts.
 SURGIMEDIC in regards to the European Medical Device Vigilance System are to report
incidents according to the following Decision Tree of MDR 2017/745/EU.
Refer the format Manufacturer's incident report
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EU Decision Tree
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4.3 CONDITIONS WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM IS NOT
USUALLY REQUIRED
Rules of Exemption from reporting as per MEDDEV 2.12/1 Rev.8 are no longer exist under
the MDR 2017/745/EU, except for expected side-effects which are clearly documented in
the product information and quantified in the technical documentation and are subject to
trend reporting.
4.4 VIGILANCE REPORTING
a. If the initial report is oral or telephonic always it shall follow a written report
b. Report may also include a statement to the effect that the report is made by SURGIMEDIC
without prejudice and does not imply any admission of liability for the incident or
consequences.
c. SURGIMEDIC shall identify the reporting criteria according to EU Decision Tree.
d. As a general rule, SURGIMEDIC shall take account the severity of the serious incident when
identifying the period for the reporting of any Serious incidents report or FSCA.
e. The following time line can apply for reporting any Serious incident:
 Serious Incident: IMMEDIATELY (Without any delay that could not be justified) after
SURGIMEDIC established the causal relationship between that incident and their device
or that such causal relationship is reasonably possible and not later than 15 days after
SURGIMEDIC become aware of the incident.
 Serious public health threat: IMMEDIATELY (without any delay that could not be
justified) but not later than 2 calendar days after awareness by SURGIMEDIC of this
threat.
 Death or UNANTICIPATED serious deterioration in a person’s state of health:
IMMEDIATELY (Without any delay that could not be justified) after SURGIMEDIC
established or as soon as it suspects a causal relationship between the device and the
serious incident but not later than 10 elapsed calendar days following the date of
awareness by SURGIMEDIC of the serious Incident.
f. To ensure timely reporting, SURGIMEDIC may submit an initial incomplete report that is
followed up by a complete report.
g. If, after becoming aware of a potentially reportable incident, SURGIMEDIC is uncertain
about whether the incident is reportable, it shall nevertheless submit a report within the
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timeframe required in accordance with paragraphs “c” to “d”.
h. Except in cases of urgency in which SURGIMEDIC needs to undertake field safety corrective
action immediately, SURGIMEDIC shall, without undue delay, report the field safety
corrective action in respect of devices made available on the Union market, in advance of
the field safety corrective action being undertaken.
i. For similar serious incidents that occur with the same device or device type and for which
the root cause has been identified or a field safety corrective action implemented or where
the incidents are common and well documented, SURGIMEDIC may provide periodic
summary reports instead of individual serious incident reports, on condition that the
coordinating competent authority has agreed with SURGIMEDIC on the format, content
and frequency of the periodic summary reporting. the manufacturer may provide periodic
summary reports following agreement with that competent authority.
j. Report shall be made to Relevant competent authority in the country of occurrence of the
INCIDENT and to SURGIMEDIC’s national competent authorities.
k. UDI shall be mandatory for use in serious incidents report when all classes of medical
devices have their own UDI.
l. All vigilance reports till now will be sent to CA by e-mails then it will be submitted to the
Electronic system (EUDAMED-When completed) for vigilance and Post market surveillance
(PMS), plus parallel submission to notified body. That Electronic system shall include
relevant links to the UDI database.
m. The data will be accessible to:
a) CA’s, Commission and Notified body (NB);
b) healthcare professionals and the public will have appropriate access level;
c) On agreement, to CA’s of third countries or international organizations.
n. Reporting of incidents involving devices that have been reprocessed is the responsibility of
the re-processor being the (Legal) manufacturer.
o. In the case of PMCF investigations, the provisions on vigilance shall apply instead.
p. Significant increase of user reports as CA shall take appropriate measures to encourage and
enable HCPs, users and patients to report to CA’s suspected serious incidents.
q. The list of national competent authority in the European Union and their contact points are
available in the European Commission web
sitehttp://ec.europa.eu/enterprise/medical_devices/contact_links_en.htm
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r. Refer the existing list under the reference document. This reference document will be
updated every 6 months once by verifying the European Commission web site.
s. The list competent authority for the European countries will be updated once SURGIMEDIC
starts exporting to European Union. The list will be updated every 6 months referring the
reference document.
Refer the format for the list of European National Competent Authorities for the device exported
to European Union
Refer the format for the list of National Competent Authorities -Non-European
Refer the format Manufacturer's incident report (MIR)
4.5 PERIODIC SUMMARY REPORTING (PSR)
a. PERIODIC SUMMARY REPORTING is an alternative reporting for individual vigilance
reporting regime used for reporting similar SERIOUS INCIDENTs with the same device or
device type in a consolidated way for which:
 the root cause has been identified or;
 a FSCA has been already implemented or where;
 the incidents are common and well documented.
b. After submitting initial reports periodic summary may be accepted by national competent
authority.
c. SURGIMEDIC may provide periodic summary reports instead of individual serious incident
reports, on condition that the coordinating competent authority, in consultation with the
competent authorities has agreed with SURGIMEDIC on the format, content and frequency
of the periodic summary reporting.
d. Where a single competent authority, SURGIMEDIC may provide periodic summary reports
following agreement with that competent authority. The periodic summary will be sent at
the end of the year accordingly by coordinating with the authorized representative.
e. The agreement will be made once SURGIMEDIC starts exporting to European Union
regions, however SURGIMEDIC doesn’t apply the PSR.
Conditions for Periodic Summary Reporting Under the Medical Device Vigilance System
4.6.1 Incidents described in a field safety notice
Incidents described in field safety notice and conducted a field safety corrective action need not be
reported individually. But periodic summary report must be sent to all National competent
authorities.
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4.6.2 Common and well-documented incidents
 Common and well-documented SERIOUS INCIDENTs (identified as such in the risk analysis of
the device and which have already led to incident reports assessed by SURGIMEDIC and the
relevant National Competent Authority) may be exempted from reporting individually by the
National Competent Authority and changed to PERIODIC SUMMARY REPORTING.
 However, these SERIOUS INCIDENTs shall be monitored and trigger levels determined. Trigger
levels for interim reporting should also be agreed with the relevant National Competent
Authority. An interim report should be made whenever trigger levels are exceeded.
Refer the format for the Manufacturer's periodic summary report
4.7 TREND REPORTING
SURGIMEDIC shall report, by means of the electronic system, any statistically significant
increase in the frequency or severity of incidents that are not serious incidents or that are
expected undesirable side-effects that could have a significant impact on the benefit-risk
analysis and which have led or may lead to risks to the health or safety of patients, users or
other persons that are unacceptable when weighed against the intended benefits. The
significant increase shall be established in comparison to the foreseeable frequency or
severity of such incidents in respect of the device, or category or group of devices, in question
during a specific period as specified in the technical documentation and product information.
a. Trend Report is mandatory in case of statistically significant increase in frequency or
severity of non-serious (non-reportable) incidents and of expected undesirable side-effects
in a specific time period, that have a significant impact on the risk-benefit analysis.
b. Methodology used for determining any statistically significant increase in the frequency or
severity of these non-serious incidents, as well as the observation period, shall be part of
the PMS plan in relation to the device acceptable risk limits in the device risk assessment
review.
c. Trend report is not anymore applicable to already reportable “Serious Incident”.
d. There is no timeline or change in format for reporting than in MDD. Expected by
implementing acts.
e. CA’s conduct own assessments on the trend reports and require SURGIMEDIC to adopt
appropriate measures in accordance with this Regulation in order to ensure the protection
of public health and patient safety. Each competent authority shall inform the Commission,
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the other competent authorities and the notified body that issued the certificate, of the
results of such assessment and of the adoption of such measures.
f. The SURGIMEDIC’s Label and / or the Instruction for use (IFU) shall contain a notice to user
and/or patient that “In case of any serious incident that has occurred in relation to the
devices should be reported to SURGIMEDIC and CA”.
g. Upon Complaint investigation and upon immediate or regular review of trend on incidents
that are not serious incidents or that are expected undesirable side-effects that could have
a significant increase of the severity measured as possible consequence and / or increase of
the probability of occurrence of harm in such a way that could lead to unacceptable
Residual Risk and significant impact on the benefit-risk analysis according to the device risk
management as specified in the technical documentation and product information, shall be
considered for trend reporting.
h. The final decision to report is complemented by health hazard assessment in which the
residual risk is weighted against the intended benefits.
Refer the format for Manufacturer's trend report
4.8 INVESTIGATIONS
a. SURGIMEDIC in regards to the European Medical Device Vigilance System are to report
incidents according to the EU Decision Tree.
b. Significant level of investigation & evaluation in serious incidents by SURGIMEDIC:
 SURGIMEDIC shall, without delay, perform the necessary investigations in relation
to the serious incident and the devices concerned. This shall include a risk
assessment of the incident and field safety corrective action taking into account
criteria as appropriate.
 SURGIMEDIC shall co-operate with the competent authorities and where relevant
with the notified body concerned during the investigations referred to in the first
subparagraph and shall not perform any investigation which involves altering the
device or a sample of the batch concerned in a way which may affect any
subsequent evaluation of the causes of the incident, prior to informing the
competent authorities of such action.
c. Significant level of investigation & evaluation in serious incidents by CA:
 Requires significant information from SURGIMEDIC including risk assessment per
case.
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 CA may intervene in SURGIMEDIC’s investigation or initiate an independent
investigation, possibly without involving SURGIMEDIC being not mandatory.
 The evaluating CA shall, through the Electronic system, inform other CA’s of the
corrective action taken by SURGIMEDIC or required of it to minimize the risk of
recurrence of a serious incident.
4.8.1 Follow Up of Investigations
 Appropriate actions will be taken based on the outcome of investigation after consulting
National Competent Authority.
 Follow up report will be sent if the investigation time reaches the time line given to the
National Competent Authority within the initial report.
4.8.2 Final Report
 The action taken will be based on the outcome of the investigation.
 The written statement of the outcome of the investigation and of any action taken will be send
to the National Competent Authority as Final report to whom the initial report has been sent.
Examples of actions may include:
a) no action;
b) additional surveillance of devices in use;
c) preventive action on future production;
d) FSCA
 Final report shall be prepared based on investigation in continuation to initial report within 15
days of initial report and should be send to National Competent Authority.
 The report is made by SURGIMEDIC to the National Competent Authority(ies) to whom
SURGIMEDIC sent the initial report.
 If the National Competent Authority is performing the investigation and SURGIMEDIC will
compile results and will document the report as final report.
4.9 RECALL OR WITHDRAWAL OF PRODUCT
a. Recall: means any measure aimed at achieving the return of a device that has already been
made available to the end user. (END USER LEVEL)
b. Withdrawal: means any measure aimed at preventing a device in the supply chain from
further being made available on the market (DISTRIBUTOR LEVEL)
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c. The reasons which lead to a product recall include
 Deterioration or malfunction in the characteristics and performance of the device
 Inadequacy in the instruction for use which may lead to a death of a patient or serious
deterioration in the state of health
d. Customers are intimated about the recall through an urgent field safety notice.
SURGIMEDIC also intimates the notified body, competent authorities of nations affected and also
the national competent authority’s responsible or authorized representative
4.4 FIELD SAFETY CORRECTIVE ACTION (FSCA)
a. Field Safety Corrective Action (FSCA): means corrective action taken by the manufacturer for
technical or medical reasons to prevent or reduce the risk of a serious incident in relation to
a device made available on the market.
b. SURGIMEDIC will report to the National Competent Authority any technical or medical
reason leading to a systematic recall of devices. This is mainly carried out to reduce risk of
death or serious deterioration in the state of health associated with the use of medical
device that is already placed in the market.
c. SURGIMEDIC issue a notification to the Competent Authorities of all countries affected at the
same time and to the National Competent Authority responsible for the authorized
representative and also to the notified body.
d. Possibility of conducting field actions (advisory, recall, withdrawal) related to device which is
not conformity with this regulation and not related to “serious incident’ (not FSCA), without
the need for notifying CA.
e. Except in case of urgency, draft FSN is to be submitted to the coordinating or evaluating CA
(Where manufacture or EC representative has his registered place of business) to allow
comment.
f. Except in cases of urgency in which SURGIMEDIC shall need to undertake field safety
corrective action immediately, without undue delay, report the field safety corrective action
in respect of devices made available on the Union market, in advance of the field safety
corrective action being undertaken.
g. SURGIMEDIC shall ensure that information about the FSCA taken is brought without delay to
the attention of the concerned users by means of FSN. The FSN shall be edited in an official
Union language or languages determined by the Member State in which the FSCA is taken.
The FSN shall allow the correct identification of the device(s) involved, in particular by
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including the relevant UDIs, and the correct identification, in particular, by including the SRN,
if already issued. The FSN shall explain, in a clear manner, without understating the level of
risk, the reasons for the FSCA with reference to the device malfunction and associated risks,
and shall clearly indicate all the actions to be taken by users.
h. Such actions should be notified via a field safety notice and FIELD SAFETY CORRECTIVE
ACTION report (FSCA). FSCA may include:
 Return of medical device to the supplier
 Device modification that may include:
Permanent or temporary change in the labeling or instructions for use
 Device exchange
 Device Destruction
 Retrofit by purchase of manufacture’s modification or design change
 Advice given by SURGIMEDIC regarding the use of the device
 A request to pass the FIELD SAFETY NOTICE to all those who need to be aware of it
within the organization and to maintain awareness over an appropriate defined period is
also included.
i. FSCA should be notified to the customers via a FIELD SAFETY NOTICE. Contact point for
customers how and when to reach the designated person also included in the FIELD SAFETY
NOTICE.
j. CA shall also evaluate the adequacy of the FSCA and the need for any other corrective
action, taking into account the principle of inherent safety (The advisory notice will not be
longer acceptable).
k. SURGIMEDIC shall enter the FSN in the Electronic system through that notice shall be
accessible to the public
l. An acknowledgment form for the receiver also included along with the FIELD SAFETY NOTICE
m. Removals from the market for purely commercial non-safety related reasons are not
Included under the scope of this procedure
4.4.1 NOTIFICATION TO NATIONAL COMPETENT AUTHORITIES:
4.4.1.1 SURGIMEDIC should issue a notification (see below) to the Competent
Authorities
I. Relevant parts from the risk analysis.
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II. Background information and reason for the FSCA (including description of the
device deficiency or malfunction, clarification of the potential hazard associated
with the continued use of the device and the associated risk to the patient, USER or
other person and any possible risks to patients associated with previous use of
affected devices).
III. Description and justification of the action (corrective/preventive).
IV. Advice on actions to be taken by the distributor and the USER (include as
appropriate:
 identifying and quarantining the device,
 method of recovery, disposal or modification of device
 recommended patient follow up, e.g implants, IVD
 a request to pass the FIELD SAFETY NOTICE to all those who need to be
aware of it within the organization and to maintain awareness over an
appropriate defined period.
 a request for the details of any affected devices that have been
transferred to other organizations, to be given to Euromedand for a copy
of the FIELD SAFETY NOTICE to be passed on to the organization to which
the device has been transferred).
 Affected devices and serial / lot / batch number range
 In the case of an action concerning lots or parts of lots an explanation why
the other devices are not affected.
 Identity of SURGIMEDIC /AUTHORISED REPRESENTATIVE
4.4.2 CONTENT OF THE FIELD SAFETY NOTICE
I. A clear title, with “Urgent FIELD SAFETY NOTICE” followed by the commercial name of
the affected product, an FSCA-identifier (e.g. date) and the type of action (e.g. see
chapter 4 definition of a FSCA).
II. Specific details to enable the affected product to be easily identified e.g. type of
device, model name and number, batch/lot or serial numbers of affected devices and
part or order number.
III. A factual statement explaining the reasons for the FSCA, including description of the
device deficiency or malfunction, clarification of the potential hazard associated with
the continued use of the device and the associated risk to the patient, USER or other
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person and any possible risks to patients associated with previous use of affected
devices.
IV. Advice on actions to be taken by the USER, Include as appropriate:
 identifying and quarantining the device,
 method of recovery, disposal or modification of device
 recommended review of patient’s previous results or patient follow up, e.g
implants, IVD
 time lines.
V. A request to pass the FIELD SAFETY NOTICE to all those who need to be aware of it
within the organization and to maintain awareness over an appropriate defined
period.
VI. If relevant, a request for the details of any affected devices that have been
transferred to other organizations, to be given to SURGIMEDIC and for a copy of the
FIELD SAFETY NOTICE to be passed on to the organization to which the device has
been transferred.
VII. If relevant, a request that the recipient of the FIELD SAFETY NOTICE alerts other
Organizations to which incorrect test results from the use of the devices have been
sent. For example, failure of diagnostic tests.
VIII. Confirmation that the relevant National Competent Authorities have been advised of
the FSCA.
IX. Any comments and descriptions that attempt to:
a) serve to play down the level of risk in an inappropriate manner
b) Advertise products or services should be omitted.
X. Contact point for customers how and when to reach the designated person.
Refer the format Manufacturer's field safety corrective action report
Refer the format Urgent field safety notice
Refer the acknowledgment form
4.5 Significant coordination and central data analysis by CA & Commission:
a. The MDCG shall assist the CA's in coordination of activities in fields of vigilance and
market surveillance in the European Union.
b. New system and tool by Commission and CA to proactively monitor vigilance data, to
identify trends, patterns or signals of new risks or safety concerns.
c. When previously unknown risk identified or the frequency of an anticipated risk
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significantly and adversely changes the benefit-risk determination, the (coordinating) CA
shall inform the manufacturer, or EC representative, who shall take the necessary
corrective actions
d. The evaluating CA shall, through the Electronic system, inform other CA's of the
corrective action taken by the manufacturer or required from it to minimize the risk of
recurrence of a serious incident, including the outcome of its assessment.
e. CA's conduct own assessments on trend reports and may require the manufacturer to
adopt appropriate measures. CA shall inform the Commission, other CA's & NB.
4.6 Significant Impact of Vigilance System & Data analysis by CA & Commission
a. Vigilance info is basis for CA surveillance activities (unacceptable risk or non-compliances)
including product testing, and announced & unannounced inspections
b. The monitoring of NB by CA shall consider data arising from vigilance and PMS to guide
its activities. MDCG with CA or in joint assessment may sample technical documentation
& clinical evaluation assessed by NB to a greater or lesser proportion based on vigilance
data.
c. CA and the Commission can after consulting the MDCG, decide, by means of
implementing acts on reclassification based on vigilance data.
4.7 Significant Impact of Vigilance System & Data
a. PMS is critical for conformity assessment application with NB.
b. Use of vigilance data by expert panel for decisions on conformity assessment procedure in specific
cases of implantable class III, and Class Ilb active devices intended to administer and/or remove
medicine
c. NB audit ensures application of the provisions on vigilance during surveillance & during re-
certification.
5.0 REFERENCE
 EN ISO 13485:2016 Clause 8.2.3 Reporting to Regulatory Authorities
 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as last amended by
Directive 2007/47/EC
 MEDDEV 2.12/1 Rev.8 – Guidelines on a Medical Devices Vigilance System
 MDR 2017/745/EU – Chapter VII, Section 2 - Article 87, 88, 89, 90, 91 & 92
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6.0 TEMPLATES
1. List of European National Competent authorities MKT/F/13
2. List of Non-European National Competent authorities MKT/F/14
3. Urgent field safety notice MKT/F/15
4. Acknowledgment form MKT/F/16
5. Manufacturer's incident report MKT/F/17

6. Manufacturer's field safety corrective action report MKT/F/18
7. Manufacturer's periodic summary report MKT/F/19
8. Manufacturer's trend report MKT/F/20
7.0 REVISION HISTORY
Revision No. Release Date Reason Next Review Date

R0 12.03.2011 Initial Release NA
R1 14.08.2012 EN ISO 13485:2012 updating NA
R2 22.02.2015 Updating of the procedure based on Internal audits NA
R3 12.10.2016 Updating of the procedure based on Internal audits NA
R4 04.10.2018 EN ISO 13485:2016 Updating 03.10.2020
Updating of the procedure based on the MDR
R5 01.06.2021 NA
2017/745
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26 Vigilance Control System-R5

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QUALITY SYSTEM PROCEDURE

Document. ID & Rev.

4.1.1 ROLE OF SURGIMEDIC (MANUFACTURER):

Primary responsibilities of SURGIMEDIC in regards to the European Medical Device Vigilance

5. Manufacturer's incident report MKT/F/17

Revision No. Release Date Reason Next Review Date

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