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An Introduction to the Medical Device Regulation

This seminar 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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

Course Overview

This seminar provides an invaluable overview of the European Medical Device Regulation (MDR). The interactive programme will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer’s responsibilities. 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 days of intensive training.

For a more advanced follow-on course from this, please see our Advanced Regulatory Affairs for Medical Devices which you may also be interested in.

Who should attend

Past delegates include those working in regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.

Programme

What is a medical device?

  • Definition
  • Examples

Europe and the MDR – overview of the regulations applicable for bringing a medical device to market

Economic operators and other parties

  • Who are they?
  • How do they interrelate?
  • What are their responsibilities?

Classification of devices

  • What are the classes and how do we classify devices?

Conformity assessment procedures

  • The routes to CE marking
  • What is required for each class of device?

Workshop 1: Classification

Manufacturers’ responsibilities

  • Technical file and design dossier requirements

Quality systems

  • EN ISO 13485: 2012 and 2016
  • The requirements for a quality system

Labelling of devices

  • Use of language and symbols
  • Instructions for use

Workshop 2: Labelling

Clinical evaluations

  • European regulatory environment
  • When are clinical investigations necessary?
  • What is required by the competent authority, Ethics Committee and Notified Body?

Workshop 3: CE marking

Medical device vigilance

  • Adverse event reporting
  • Reporting requirements
  • Post-market surveillance (PMS)

Workshop 4: Vigilance

Drug/device combinations

  • Drug or device?
  • Examples of classification

Devices incorporating material of animal origin

  • Animal-derived materials legislation
  • Directive 2003/32/EC

The revision to the regulations for medical devices

Presenters

Janette Benaddi (More...)

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.

Will Burton (More...)

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.

Theresa Jeary (More...)

Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.

She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.

Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 8-10 Feb 2022
  • 18-20 May 2022
  • 1-3 Aug 2022
  • 8-10 Nov 2022

Book now

You may also be interested in

Previous customers include...

  • Abbott Diabetes Care Ltd
  • Abbvie Deutschland GmbH & Co. KG
  • Baxter Innovations GmbH
  • BD & Company
  • Becton Dickinson East Africa Limited
  • Besins Healthcare Pharma Services Ltd
  • Chiesi Farmaceutici SPA
  • ConvaTec UK Ltd
  • FibroTx OU
  • Grünenthal GmbH
  • Inivata Ltd
  • Kent Community Health NHS Foundation Trust
  • LEO Pharma
  • MHRA
  • MHRA/NIBSC
  • Novo Nordisk AS
  • Oystershell
  • P3 Medical Ltd
  • Pierre Fabre Medicament
  • Research and Markets
  • Shire
  • Systagenix Ltd (an Acelity company)
  • System C
  • Takeda Pharma A/S
  • Teva Pharmaceuticals
  • Teva Pharmaceuticals Ltd
  • UKR Regulatory Affairs Limited
  • United Therapeutics
  • Weifa AS
  • Winthrop Pharmaceuticals UK Ltd

Excellent!! Speakers were very knowledgeable and approachable.

Morag Appleton, Pharmacovigilance Manager, Dermal Laboratories Ltd, May 21

A very good all round course. I learnt a lot and will take the information away with me to use in my dealings with Medical Devices.

Jennine Walker, Clinical Affairs Manager, Dermal Laboratories Ltd, May 21

Very knowledgeable speakers. The content was excellent, it is a difficult task to try and squeeze so much information into just three days!

Sarah Coverdale, Regulatory Affairs Specialist, Robinson Healthcare Limited, Nov 19

I hoped to achieve an overall picture of the new Medical Device Regulation and I think I accomplished that. The level of detail was very good and the topics touched on all of the key areas. Janette was excellent. She had very good practical examples throughout the course and made sure she spoke to all of the people attending – it was not dependent on the experience of the participants. I can highly recommend any course with Janette to my colleagues, she made everyone feel welcomed and at ease. There were lots of practical examples and the topics flowed logically. The course provided me with a very good overview of the MDR with valuable practical examples.

Eeva Dickens, QA Compliance Specialist, Otsuka Pharmaceutical Europe Ltd, Nov 19

All of the speakers were engaging and demonstrated expertise and knowledge of the subject. They encouraged discussion and debate regarding new regulations and used a range of teaching styles. The resources issued were excellent. I particularly enjoyed the workshops as an opportunity to learn from the experience of the speakers and course participants.

Marcella Capper, Head of Medical Devices, Kent Community Health NHS Foundation Trust, Nov 19

After completing the course, I feel much more aware of the current regulatory environment surrounding medical devices. Overall, I would say that this training achieved what was intended.
I particularly liked the workshops that allowed us to apply what we learned and apprecaiated how many resources were provided to us through the course of the training. The topics selected were pretty comprehensive, I found that the collective expertise of the presenters was top class and the information was generally well represented. I would definitely opt to attend another Management Forum training event – very professional and well organized.

Liz Renzaglia, Product Excellence Assistant, Oystershell NV, Nov 19

Very comprehensive, complete overview, interesting topics, great speakers, good organisation as well!

Steven Vinkx, Quality Engineer, Quality by Design, May 19

It was a well organised course with knowledgable speakers. The content is very broad but to the point.

Emma Van Til, Regulatory Affairs Associate , Ophtec B.V., May 19

Before the course I knew very little on MDR and now my visibility has hugely increased. The content was heavy but just right. The presentation and speakers were balanced and paced perfectly. I can not say anything to improve.

Jeffrey Watts, Principal Quality Engineer, BD, May 19

The course was well laid out in terms of topics and depth. Each topic was touched on in day one, but knowledge and understanding was built upon each day, which increased retention. The speakers were all very knowledgable on their subjects and easy to approach with any questions.

Isha Hodgson, Test Lab Supervisor, Becton Dickinson, May 19

it was very interesting and detailed. The speakers were understandable and kind. I particularly found that Janette was inspiring.

Joan Wan, RA Pharmacist, Guerbet, May 19

Good content, good activities, good presentations and very experienced speakers.

Luis Mendoza Burgos, Head of Global Patient Safety, Ipsen Ltd, May 19

Very practical and useful course which provides a general view of the MD regulation in Europe.

Emmanuelle Tourte, Head of Regulatory Compliance & Data Management, Guerbet, Nov 18

Good, informative, friendly, flexible.

Jo Mair, Project Manager, University of Edinburgh , May 18

Good selection of speakers and comprehensive

Martin Aigner, Quality Product Owner, Baxter AG, Nov 17