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Guidance Document Post Market Surveillance (PMS) Periodic Safety Update Report (PSUR) Post Market Clinical Follow-up (PMCF)


Table of Contents 1.0

Introduction .................................................................................................................. 3

2.0 Scope and Objective ............................................................................................................. 3 3.0 Relationship between PMS/PSUR/PMCF .............................................................................. 3 4.0 PMS/PSUR/PMCF under EU MDR ......................................................................................... 3 5.0 PMS/PMCF/PSUR under MDD .............................................................................................. 3 6.0 Conclusion ......................................................................................................................... 11

Appendix A: Explanation of PMS/PSUR/PMCF under the EU MDR 745/2017 .................... 12


1.0 Introduction The Post-market surveillance (PMS) was a process which already existed in the EU MDD in Annex X but it was not clearly defined through the EU MDD. On the other hand, the new regulation EU MDR has clearly defined the PMS which also includes the Post Periodic Safety Update Report (PSUR) and Post Market Clinical Follow Up (PMCF), as agreed with the European Parliament and Council in May 2017. The new EU MDR is valid from the 26th of May 2020 and till this date; the medical devices must meet the new requirements of EU MDR. The EU MDD is now expanded to EU MDR, although many parts have changed, renamed or added. In the EU MDR the post-market surveillance, changed and became more complicated which is expand in the Articles 83, 84, 85. In addition, descriptions of PSUR and PMCF are found in Article 86 and Annex XIV respectively, of the EU MDR.

2.0 Scope and Objective This report is aiming to give guidance to the manufacturers, how to respond to their responsibilities and develop a post-market surveillance report and meanwhile meet the requirements of EU MDR. The purpose of this report is to collect all the information from 2017/745 EU MDR about post-market surveillance, post periodic safety update report and post market clinical follow up and explain their requirements. In addition, where it is applicable the EU MDR is compared with MDD.

3.0 Relationship between PMS/PSUR/PMCF PMS is a procedure referred to the manufacturer of medical devices and is an essential process in order 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 PMS is part of the Quality Management System (QMS) and includes further procedures such as Post Market Clinical Follow Up (PMCF) which is already introduced in EU MDD and expanded in EU MDR. Also, the EU MDR introduce the Periodic Safety Update Report (PSUR) which is a summary of the results and the analysis of the PMS data. Diagram 1 represents the subdivisions of the QMS in regard to PMS and show the key requirements of PMS procedures.

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PMS PSUR PMCF Gap Assessment  

The Post Market Surveillance (PMS) is a post phase process which is accomplished by the manufacturer. If the device is classified as Class I...

PMS PSUR PMCF Gap Assessment  

The Post Market Surveillance (PMS) is a post phase process which is accomplished by the manufacturer. If the device is classified as Class I...

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