Post-Market Surveillance: A Concise Overview of Requirements

Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.

During the MedTech Summit this year, I will be on two panels of RQM+ experts and we hope you will join us. First, on Wednesday 20th October we will be speaking on ‘PMS Requirements of the EU MDR: Implementation Challenges and Solutions’ where we’ll be looking at PMS successes and failures so far, as well as some of the best practice solutions that have emerged.

Ahead of this session, it is valuable to review what the specific PMS requirements are under the MDR. This diagram neatly summarizes the requirements for PMS documentation, further detailed below.

1. VIGILANCE

Manufacturers of devices made available on the EU market (other than investigational devices) must report any serious incident and any field safety corrective action related to these devices.

2. POST-MARKET SURVEILLANCE PLAN

The PMS Plan presents the processes and activities that will be conducted to monitor the safety and performance of the device once it is on the market.

3. POST-MARKET CLINICAL FOLLOW-UP PLAN

A PMCF Plan is required for all devices under MDR, to specify the methods and procedures the manufacturer will use to collect and evaluate clinical data for their medical devices.

4. PERIODIC SAFETY UPDATE REPORTS (PSUR)

This needs to be updated annually for Class IIb and III devices, and every two years for Class IIa devices, then submitted to a Notified Body. The PSUR summarizes results and conclusions from post-market surveillance data evaluation, including a rationale and description of any corrective and preventive actions.

5. PMCF EVALUATION REPORT

This sits in the Clinical Evaluation Report and Technical Documentation, and needs to be updated annually for Class III and Implantables, or as needed for other classes. The PMCF Evaluation Report analyses the findings of PMCF activities, as foreseen in the plan.

6. PMS REPORT

This report is for Class I devices and should be updated as needed, but must be available to the Competent Authority on request.

7. SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP)

The SSCP provide a description of the device, its intended purpose, a description of possible diagnostic or therapeutic alternatives, and a summary of the clinical evidence demonstrating the clinical safety and performance of the device.

Where to find us at MedTech Summit 2021

Stop by our virtual showcase hub for access to premium content and be sure to attend our expert panel discussions:

PMS Requirements of the EU MDR: Implementation Challenges and Solutions
Wednesday, 20 October at 15:10 - 15:50 CET/CEST

Join our session and have your questions answered live by a panel of former Notified Body (NB) leadership and PMS experts. Panelists in this session will also discuss:

• Best practices for optimizing every element of PMS/PMCF as it relates to the EU MDR at your organization
• What typical NB findings have been so far and how interpretations may vary related to PMS requirements
• Strategies to overcome audit findings and gaps in your evidence

Panelists:

• Amie Smirthwaite BEng, PhD, RQM+ Global Vice President, Intelligence & Innovation
• Celeste Maksim, PhD, RAC, RQM+ Chief of Staff, Clinical & Post-Market Practice
• Ed Ball CEng MIPEM MIMMM, RQM+ Senior Associate
• Andrew Tarnaris, RQM+ Medical Director
• Moderated by Lisa Casavant, RQM+ Executive Vice President

IVDR Implementation Best Practices and Challenges Roundtable
Thursday, 21 October at 17:20 CET

Learn from the experiences of seasoned IVDR experts – including Notified Body perspectives – as they share their IVDR implementation successes and failures so far, along with answers to your questions. Our expert panel has worked through comprehensive strategies and solutions and is prepared to share their learnings and tips for success.

Panelists:

• Amie Smirthwaite BEng, PhD, RQM+ Global Vice President, Intelligence & Innovation
• Celeste Maksim, PhD, RAC, RQM+ Chief of Staff, Clinical & Post-Market Practice
• Nancy Morrison, RAC, RQM+ Executive Director, Regulatory & Quality Services