Medical Device Studies: Regulatory Requirements and Adverse Event Reporting London, United Kingdom-October 12, 2018

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This seminar 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.

Agenda:

09.30 Welcome and introduction

09.45 Clinical investigations and evaluations – when is an investigation needed?

How to perform a clinical evaluation

When are clinical investigations needed

The regulatory requirements

10.35 PMS and post market clinical follow up studies

What is PMS

What do the regulations entail

When are PMCF studies necessary

11.00 Refreshments

11.15 Vigilance reporting

What is vigilance

The requirements for vigilance reporting

11.45 How to define and classify adverse events

  • Definitions
  • Types of events
  • Determining categories

12.15 The regulatory requirements for monitoring and reporting adverse events during regulatory and post market clinical follow up studies

  • MEDDEV guidance document
  • ISO 14155 harmonised standard
  • Responsibilities
  • Post market clinical follow up studies

12.50 Discussion

13.00 Lunch

14.00 Vigilance workshop

14.30 The new Medical Device Regulations

  • Structure and overview of the new regulation
  • Some of the main changes
  • Final provisions – transitional arrangements

15.30 Discussion

15.45 Refreshments

16.00 The new Medical Device Regulations – clinical elements

  • Focus on changes in the clinical arena
  • Chapter VI Clinical Evaluation and Investigation
  • Annex XIV Clinical Investigations

16.40 The role of the Competent Authority (CA)

  • What is the involvement of the CA
  • Communicating with the CA
  • What to communicate and when

17.00 Discussion and end of forum

More information can be found here.