Document ID: Revision No.:
Effective Date:
Written By:
# #
<date>
Other references
Version:
Date:
Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) (Your company logo)
Document Number:
Report Approval Print name
Revision #
Position
Signature
DOCUMENT REVISION HISTORY Description of Change Author
Date
Date
Document ID: Revision No.:
Effective Date:
# #
<date>
Table of Contents 1.0
Introduction .................................................................................................................. 3
2.0
Key Objectives ............................................................................................................. 4
3.0
Responsibilities ............................................................................................................ 4
4.0 Procedure .......................................................................................................................... 4 4.1 PMS Plan ....................................................................................................................... 5 4.2 PMS Review ................................................................................................................... 8 4.3 PMS Report .................................................................................................................... 8 4.4 PSUR ............................................................................................................................. 8 Appendix: Explanation of PMS/PSUR under the EU MDR 745/2017 .................................... 10
Red text = needed to be changed and write the information of the product Grey text = add the text if itâ&#x20AC;&#x2122;s necessary according to the needs of product Blue text = the context needs to be added by the responsible body(manufacturer)
Document ID: Revision No.:
# #
Effective Date:
<date>
1.0 Introduction PMS is a procedure referred to the manufacturer of medical devices and is an essential process for the product to become available on the market. PMS is a systematic procedure of the post phase of the production where the manufacturer review and evaluate the experience gained from the device. The manufacturer is responsible to carry out any appropriate corrective action after evaluation of the experience. The systematic procedure is document and be always up to date. The post-market surveillance according to the 2017/745 EU MDR must include urgent and non-urgent incidents and Periodic Safety Update Reports (PSUR) for only class IIa, IIb and III devices. The purpose of this document is to define the Post Market Surveillance (PMS) activities of the product XXXX. The range of products is listed below (if necessary). Range
of
Product
(add
and
remove XXXX
XXXX
columns) Medical Device Family/Category Device Name(s) Add any relevant information about the product such as device identifier etc. Device Description At this section give a brief summary of the function of the device (usage of the device), a summary of the warnings, the identification of product labelling, principles of operations etc. and attach the design specification in Appendances.