Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

This In-house course gives an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.

Course Overview

This In-house course provides an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting for medical device clinical studies complying with the European Medical Device Directive 93/42/EEC. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.

Your team will:

  • HEAR all you need to know about the regulatory requirements for monitoring and reporting adverse events in one information packed day
  • FIND OUT when a clinical investigation is need
  • DISCOVER the requirements for vigilance reporting
  • UNDERSTAND the main changes involved with the new Medical Device Regulations
  • APPRECIATE the role of The Competent Authority and how to, when to, and what to communicate with the authority

What Team Would Benefit

  • Regulatory affairs specialists
  • Quality assurance specialists
  • Clinical research associates
  • Junior clinical research associates

Sample Programme

Welcome and Introduction

The regulatory requirements for monitoring and reporting Adverse Events during regulatory and Post Market Studies
  • Update on the changes and guidance
  • MEDDEV
  • ISO 14155
How to define and classify Adverse Events
  • Definitions
  • Types of events
  • Determining categories
Clinical investigations and evaluations – When is an investigation needed?
  • How to perform a clinical evaluation
  • When are clinical investigations needed?
PMS and Post-Market clinical follow-up studies
  • What is PMS?
  • What do the regulations entail?
  • When are PMCF studies necessary?
Vigilance reporting
  • What is vigilance?
  • The requirements for vigilance reporting
The proposed New Medical Device Regulations
  • What the new regulations involve
  • Some of the main changes
  • Focus on changes in the clinical arena
The role of The Competent Authority (CA)
  • What is the involvement of the CA?
  • Communicating with the CA
  • What to communicate and when

Recommended Trainer

Kath Clarke

Kath Clarke is an independent consultant to the Medical Device industry; she was previously the Regulatory Affairs and Quality Assurance Manager at Medvance, a Clinical Research Organisation.

She has a BSc in Chemistry and was previously a member of BARQA’s Medical Device Committee. She has also resided on two BSi Committees concerning Healthcare Standards.

She started her career in the Medical Device Industry more than 30 years ago, when she joined Smith & Nephew. During her time there she held a variety of QA and RA roles in numerous divisions covering various therapeutic areas. After leaving Smith & Nephew she moved to Tissue Science Laboratories, where she held the position of Regulatory Affairs Manager, her responsibilities being many and varied; including CE marking and product registration in global markets.