An Introduction to the Medical Device Regulation

This In-house course provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

In-house Training and Consultancy Services

This In-house course provides a detailed introduction to the European medical device legislation. It will explain the Directives, products covered, involvement of Notified Bodies as well as the best course of action for manufacturers. It will also cover the documentation necessary to apply for the CE Mark.

This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample Programme - Day One

What is a Medical Device?

  • Definition
  • Examples

Europe and the Medical Device Directives

  • What is a Competent Authority, Notified Body and an Authorised Representative?
  • How do they inter-relate?
  • Responsibilities of each party
Classification of Devices
  • Review of definitions
  • The 18 rules

Conformity Assessment Procedures

  • Optional routes for each class
  • What is required for each class

Workshop 1: Classification

Sample Programme - Day Two

Manufacturer’s Responsibilities
  • Technical file and design dossier requirements
Quality Systems
  • EN ISO 13485
  • The requirements for a quality system
Clinical Evaluations
  • European Regulatory environment
  • When are Clinical Investigations necessary?
  • What is required by the Competent Authorities, Ethics Committee and Notified Body?

Workshop 2: Clinical Evaluations

Medical Device Vigilance
  • Adverse Event reporting
  • Reporting requirements
  • Post Market Surveillance (PMS)

Workshop 3: Vigilance

Sample Programme - Day Three

Labelling of Devices
  • Use of language and symbols
  • Instructions for use

Workshop 4: Labelling

Drug/Device Combinations
  • Drug or device?
  • Examples of classification
Devices Incorporating Material of Animal Origin
  • Animal derived material legislation
  • Directive 2003/32/EC

The Draft Proposed Revision to the Regulations for Medical Devices and In-Vitro Diagnostics

Recommended Trainers

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a variety of services from preclinical to post market activities throughout the medical device product development cycle.

She has over 20 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 in conducting clinical studies with medical device products as well as regulatory expertise in CE marking of devices.

Janette is a registered nurse, and has obtained a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies. She lso 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. She has published several articles relating to medical device regulation and clinical studies.

Will Burton

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.