Post Market Surveillance procedure

PURPOSE:
Post Market Surveillance (PMS) is defined as "a systematic process to derive necessary corrective and preventive
actions (CAPA) from information on medical devices already placed on the market".
To have an established documented procedure for a feedback system to provide early warnings of quality problems
and for input into the corrective and preventative action processes. The intention is for X to gain experience from
the post-production phase, the review of this experience to constitute an overall Post Market Surveillance (PMS)
System. As such it is also part of the continuous improvement process.

RESPONSIBILITY:
The overall responsibility is with the Management Representative (MR).

NORMATIVE REFERENCES:
1. Guidelines on Medical Device Vigilance System; MEDDEV 2.12/1 rev 8; January 2013
2. Regulation (EU) 2017/745 of European Parliament and of the Council of 5 April 2017 on medical device, Article
87, 89, 85. 3.
Guidelines on Post Market Clinical Follow-Up Studies; MEDDEV 2.12/2 rev 2; January 2012

SCOPE:
The performance of Quality Management System and all associated inputs, including that X company has met
customer requirements.

1. GENERAL PRINCIPLES:
1.1. This document is intended to indicate a high-level system approach with respect to Post Market Surveillance
(PMS) activities for X company products, services and quality systems.
1.2. X has various procedures and forms in place to monitor devices in the market, post sales. As indicated in
Regulation (EU) 2017/745 of European Parliament and of the Council of 5 April 2017 on medical device, and various
quality standards, monitoring the product do not end at the production release stage.

1.3. It is not intended to be totally inclusive of every document used for feedback purposes; as these are mainly
referenced in the appropriate procedures (see Section 2). This procedure is intended to reinforce the fact that an
overall Post Market Surveillance (feedback) system is clearly in place.

1.4 The PMS interface

RISK MANAGEMENT

DESIGN CONTROL

USABILITY ENGINEERING

VIGILANCE, COMPLAINT, FEEDBACK

CLINICAL EVALUATION, PMCF

MANAGEMENT, INTELLECTUAL PROPERTY

QUALITY MANAGEMENT

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2. RELEVANT PROCEDURES
2.1 Control of nonconforming product
This procedure is intended to fully investigate customer complaints to determine the cause and take the
necessary remedial action, determine methods to preclude re-occurrence of the problem and to keep the customer
fully informed. Besides to ensure that corrective and preventive action is a vital closed loop system of root cause
analysis, documented action, verification of effectiveness, and prevention of recurrence.

2.2 Recall & Advisory notice

This procedure covers the actions to be taken once X company or a National Competent Authority receives
information concerning an “Incident” involving a Medical Device.

2.3 Internal Audit

This procedure is intended to ensure that the Quality Assurance System is operating effectively and to ensure
that personnel fulfil their responsibilities and duties adequately. The activities in this procedure will assure the
company’s Quality objectives and requirements are met.

2.4 Data Analysis

This procedure is intended to ensure analyse of feedback information. The objective of the system is meeting
of customer requirements as well as applicable regulatory requirements.

3. POST MARKET SURVEILLANCE (PMS) PHASES:

State Health Care Accreditation Agency Database

http://www.vaspvt.gov.lt/node/117
US FDA MAUDE Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Database of Adverse Events Notifications (DAEN)
http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx
MHRA Medical Device Alerts (UK)
https://www.gov.uk/drug-device-alerts
Database (US FDA Medical & Radiation Emitting Device Recalls)
http://www.fda.gov/Radiation-EmittingProducts/
Scientific database (PubMed)
https://www.ncbi.nlm.nih.gov/pubmed/
Scientific database (ClinicalTrials.gov.)
https://clinicaltrials.gov/

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Scientific database (PubMed)
https://www.ncbi.nlm.nih.gov/pubmed/
Scientific database (ClinicalTrials.gov.)
https://clinicaltrials.gov/

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 PMS ataskaita / PMS report
Proactive ....MD Post Market Surveillance (PMS) Reactive Vigilance .....MD phase
phase

Data source Results ..MD Results of similar devices Data source and action

End users complaints

State Health Care Accreditation Agency
All verbal and written complaints, users reviews are logged in ‚QMS documents and records
http://www.vaspvt.gov.lt/node/117 log.xls‘, ‚Log of nonconformity, incidents‘ .
US FDA MAUDE Database

Notification about event is analysed to determine if it meets basic reporting criteria A – C

listed under section 5.1.1. (MEDDEV 2.12/1 rev 8 Vigilance).
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Database of Adverse Events Notifications (DAEN)

http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

MHRA Medical Device Alerts (UK) Reporting (Manufacturer’s Incident Report , Manufacturer’s Field Safety Corrective Action
Report, Medical Devices Vigilance System, MEDDEV 2.12/1 rev 8) to relevant National
Competent Authority (State Health Care Accreditation Agency: Jeruzalės g. 21, LT-08420,
Vilnius; tel. (85) 261 5177, [email protected]; www.vaspvt.gov.lt.

https://www.gov.uk/drug-device-alerts
Database (US FDA Medical & Radiation Emitting Device Recalls)

After the investigation of complaint is completed, relevant communication is established

http://www.fda.gov/Radiation-EmittingProducts/ with Manufacturing contractor.
Scientific database (PubMed)

https://www.ncbi.nlm.nih.gov/pubmed/ Period span

Scientific database (ClinicalTrials.gov.) Immediately after receiving complaint

(https://clinicaltrials.gov/ Results Results

No end users complaints due Data source and action
toABILI BALANCE MD during 2019
year. Manufacturer's final device control

If during final deivce control, comparing the accuracy of MD measurements with a reference
device or using 3D motion analysis device, acceptable limit (±3%) is exceeded, the device is
considered as nonconforming product.

Non-comformity is logged in ‚QMS documents and records log.xls‘, ‚Log of nonconformity,

incidents‘ for further investigation.

Action and period span - yearly Period span

Yearly regular follow-up of information referring to identified databases Continually

Data Analysis
1