Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting

25-26 Feb 2020

& 22-23 Sep 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. 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. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

Who should attend?

  • Regulatory affairs specialists
  • Quality assurance specialists
  • Clinical research associates
  • Junior clinical research associates
  • Professionals involved in reporting adverse events during pre- and post-market clinical studies

Programme day one

Clinical evaluation – an overview

  • What is a clinical evaluation?
  • How do you conduct a clinical evaluation?
  • The regulatory requirements pertaining to clinical evaluation

Clinical investigations – an overview

  • What is a clinical investigation?
  • When are clinical investigations needed?
  • The regulatory requirements


  • What is PMS?
  • What is PMCF?
  • When are PMCF studies necessary?

Quiz on clinical evaluation, clinical investigation and PMCF

New requirements of the MDR

  • Summary of safety and clinical performance
  • Periodic safety update report (PSUR)

The competent authority and the Notified Body

  • What is their role in the above processes?
  • What are the responsibilities of the manufacturer?
  • What to communicate and when

Workshop on the new requirements of the MDR

Programme day two

Review of day one

Vigilance reporting

  • What is vigilance?
  • The requirements for vigilance reporting during medical device studies

How to define and classify adverse events

  • Definitions
  • Types of events
  • Determining categories

Vigilance workshop

The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies

  • MEDDEV guidance document
  • ISO 14155 harmonised standard
  • Responsibilities
  • Templates

The MDR – clinical elements

  • Focus on changes in the clinical arena
  • Chapter 6: clinical evaluation and investigation
  • Annex 14: clinical evaluation and post-market clinical follow-up

Discussion session and end of seminar


Janette Benaddi

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

Book now

25-26 Feb 2020
25-26 Feb 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
Limited places
22-23 Sep 2020
22-23 Sep 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Bionical Emas
  • Cochlear AG
  • Croatian Agency for Medicinal Products and Medical Devices
  • Emas Pharma Ltd
  • Ferring Pharmaceuticals
  • Flexicare Medical Limited
  • Geistlich Pharma
  • GlaxoSmithKline
  • GlaxoSmithKline Consumer Healthcare
  • Guerbet
  • Institut Straumann AG
  • Larix A/S
  • Medpace UK
  • Nottingham Clinical Trials Unit
  • Novella Clinical
  • Premier Research Poland Sp. z o.o.
  • ProductLife Ltd
  • Syneos Health
  • Teva Pharmaceuticals Industries Ltd
  • Thornton & Ross Ltd
  • University of Cambridge
  • William Cook Europe
  • Xiros Ltd
  • Zealand Pharma

Kath was very welcoming and presented well and in a way which I was able to understand. She used very good examples to help us understand the topic. I really enjoyed the course and felt it gave me a good insight and foundation to medical device studies.

Pavendeep Kumar, Principle Safety Specialist, Syneos Health

Good speaker, highly relevant content. If the data collection definitions were removed, maybe it would make room for more in-depth discussions.

Christoffer Thaysen, Clinical Research Nurse Specialist, William Cook Europe

The course had a very good structure and the Speaker was excellent. The document we received during the course is very helpful.

Aline Erhart, Clinical Safety Officer, BIOTRONIK AG

Was really good and you could tell it was a passion for the presenter which is always nice and dealt with a difficult person asking questions well at the beginning.

Jason Hemmings, Manager, Syneos Health

Speaker was very knowledgeable.

Tracy Best, Quality Assurance Manager, Flexicare Medical Limited

Very useful course, excellent speaker.

Gianluca Musolino, Clinical Research Fellow, University of Cambridge

[The speaker was] very knowledgable, [and a] clear communicator.

Iris Koenig, Director , Larix A/S

Speakers were friendly, patient and easy to approach

Imogen Burkinshaw, Safety Reporting Manager, Novella Clinical

Very detailed and informative presentation

Rukhnoor Mahmood, Project Manager, Emas Pharma Ltd

Very clear and understandable

Alison Etchells, Regulatory Affairs Officer, Thornton & Ross Ltd

Very well structured. Did well to present this content in one day.

Goranka Marusic Kontent , European Affairs Advisor , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Well prepared speaker - Good use of subjects

Emil Hofdahl, Specialist, Clinical Safety Reporting, William Cook Europe

It was good and the content gave a lot of information on medical devices. The speaker was very knowledgeable about topic.

Roshini Nellailingam, Regulatory Affairs Manager, Emas Pharma Ltd