MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers

Preconference Workshop Description: Manufacturers with MDR certificates are required to maintain their technical and clinical documentation for submission to notified bodies as part of surveillance audits and post-certification activities. This workshop will discuss the common pitfalls in such manufacturer submissions. The session will discuss how notified bodies are sampling the documentation, depending on device classification, and the frequency at which surveillance audits are performed.

Through a combination of workshop activities and group discussions, participants will gain insight into the required update cycles and the interdependencies between clinical documents. In addition, the importance of justifying decisions for updating clinical documentation will be demonstrated via different scenarios presented during the workshop activities.

The workshop will capture the collective notified body best practice for MDR surveillance, post-certification, and re-certification submissions to notified bodies.


Proposed Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Breakfast & Morning Welcome by RAPS

8:30 – 10:30 AM: Agenda Items:

Welcome and Workshop Introduction

Technical documentation sampling plans

Device changes and modifications (e.g. intended purpose, design, IFU changes, clinical outcomes)

Case Study Group Exercise



10:30 – 11:00 AM: Networking Break by RAPS

11:00 AM – 12:30 PM: Agenda Items:

Clinical Evaluation

PMS and Vigilance

PMCF

Case Study Group Exercise


12:30 – 1:30 PM: Networking Lunch Break by RAPS

1:30 – 3:00 PM: Agenda Items:

SSCP

PSUR

Case Study Group Exercise



3:00 – 3:15 PM: Networking Break by RAPS

3:15 – 4:00 PM: Agenda Items:

Review of the Day: Tying it all together!

Q&A


4:00 PM: Adjournment of All Preconference Workshops by RAPS