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Management Forum

An Introduction to the Medical Device Regulation Training Course

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.

★★★★★ "The webinar was presented very well with both speakers having a clear understanding of the changes a... more (42)"

31 July-2 August 2024
+ 4-6 November 2024 »

from £1349

Need help?  Enrol or reserve

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.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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.

Enrol or reserve

The An Introduction to the Medical Device Regulation course will cover:

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?

Workshop: 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: Labelling

Clinical evaluations

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

Workshop: CE marking

Medical device vigilance

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

Workshop: 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

Enrol or reserve

Will Burton
Russell Square Quality Associates Limited

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.

More details

Theresa Jeary

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.

More details

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

31 July-2 August 2024

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 13853

  • GBP 1,349 1,649
  • EUR 1,939 2,359
  • USD 2,201 2,669

Until 26 Jun

View basket 

Not ready to book yet?

for 7 days, no obligation

4-6 November 2024

Live online

09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
04:30-12:15 New York (UTC-05)
Course code 14013

  • GBP 1,349 1,649
  • EUR 1,939 2,359
  • USD 2,201 2,669

Until 30 Sep

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's An Introduction to the Medical Device Regulation training course

The webinar was presented very well with both speakers having a clear understanding of the changes and implications that the MDR will have. Both speakers were able to help with all questions with a clear understanding of their answers and applicability. Both speakers were very clear and very helpful with all questions and all parts were very informative, i really liked the workshops.

Nov 6 2023

Louise Bateman
Quality Manager, Bedfont Scientific Ltd

Nov 8 2022

Speakers are very knowledgeable about Medical Device products. Janette also gave us extra material that will help me navigate European regulations and explore new content.

Luciana Freddi

Aug 1 2022

Excellent course material/ presentations, clear, easy to understand and straight forward. Very welcoming and friendly speakers, with an open minded mentality to consider different regions in covering medical devices regulations. Would highly recommend the course for basic/intermediate level manufacturers and regulators.

Fajer K. Alkusair
Standards and Regulations Specialist - Medical Devices Sector, Saudi Food & Drugs Authority

Aug 1 2022

All 3 speakers were fantastic and I really liked that they were all coming from different sides of the industry, sharing their perspective on top of delivering the content

Julie Leone
Regulatory Affairs Manager , Haleon

Aug 1 2022

It was well structured, informative and interactive. well structured and concise presentation, information easy to follow. the speakers - well prepared and friendly

Iuliana Oana Constantin
RA Manager, Ascendis Wellness

Aug 1 2022

Excellent course material/ presentations, clear, easy to understand and straight forward. Very welcoming and friendly speakers, with an open minded mentality to consider different regions in covering medical devices regulations.

Fajer K. Alkusair
Standards and Regulations Specialist - Medical Devices Sector, Saudi Food & Drugs Authority

May 18 2022

Every speaker was phenomenal, very informative and put in the extra effort to do the research to answer any questions they didn't know the answer to then and there. Could not improve the webinar any more than how it was. Overall I was really impressed. Best webinar by Management forum by far - and I look forward to many more training sessions hopefully with Janette.

Angelica Morreno
Regulatory Affairs Assistant, Sinclair Pharmaceuticals

Nov 8 2022

It was really good: content was clear, presentation was good, and speakers were interesting

Alba Lerma

Nov 8 2022

Very good

Ramya Krishna Ragipindi
Regulatory Manager, Chemidex Pharma

Nov 8 2022

It was really good: content was clear, presentation was good, and speakers were interesting

Alba Lerma

May 18 2022

I enjoyed this course more than I thought I would and felt I walked away with a decent understanding of the content. Thank you!

Tina Lawton
Senior Regulatory Affairs Manager, GlaxoSmithKline

May 18 2022

Great presentations, workshops

Marie-Antoinette Serraille
Regulatory Affairs Specialist, BD

May 12 2021

Excellent!! Speakers were very knowledgeable and approachable.

Morag Appleton
Pharmacovigilance Manager, Dermal Laboratories Ltd

Nov 10 2021

Topics very interesting and up to date. Speakers very good and their speeches were understandable. Questions were welcomed and all this created a good atmosphere in the webinar and between participants and speakers. Very good!

Arberite Mjaku

May 12 2021

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

Nov 11 2019

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

May 15 2019

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

Luis Mendoza Burgos
Head of Global Patient Safety, Ipsen Ltd

May 15 2019

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 15 2019

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 15 2019

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 15 2019

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.

Nov 11 2019

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 appreciated 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 11 2019

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 11 2019

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

May 15 2019

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

Steven Vinkx
Quality Engineer, Quality by Design

Nov 12 2018

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

May 14 2018

Good, informative, friendly, flexible.

Jo Mair
Project Manager, University of Edinburgh

Nov 20 2017

Good presenter, I really understood the course.

Ramandeep Walia
Regulatory Affairs Manager, Novartis Pharmaceuticals Limited

Nov 20 2017

Great course!

Tracy Leong
Quality Lead, BTG

Nov 20 2017

Good selection of speakers and comprehensive

Martin Aigner
Quality Product Owner, Baxter AG

May 8 2017

The course was excellent with extremely knowledgeable presenters who were open to discussion and had good real world examples during the presentations

Daniel Jacob

May 8 2017

Content was very informative and the speakers were brilliant, knowledgable

Christina Obafemi
Walgreens Boots Alliance Services Limited

May 8 2017


Mirusha Thanaseelan
Regulatory Affairs Associate , Weifa AS

Nov 8 2016

Enjoyable, informative,

Sorcha Murphy
Regulatory Affairs Specialist, Johnson & Johnson Medical Ltd.

Nov 8 2016

Very good comprehensive overview. Speakers show experience and motivations. Presentations helpful.

Beata Bulawa
Regulatory Affairs Manager, Grunenthal GmbH

Nov 8 2016

High class speakers, very knowledgeable

Michelle Pugh
Quality Manager, Inivata Ltd

Nov 8 2016

Appropriate level of detail

Oliver Gazeley
Sector Project Manager - Med/Sci, DCA Design International Ltd

Nov 8 2016

Very well organized, speakers very competent

Francesca Porchia
Regulatory Affairs Specialist , Abiogen Pharma S.p.A.

May 9 2016

Good course

Ali Mohammed AlHawas
Saudi Food and Drug Authority

May 9 2016

It was informative

Abdullah Khalaf Siran
Saudi Food and Drug Authority

Nov 8 2016

Very good

Lene Ultved
Customer Feedback Professional, LEO Pharma

May 9 2016

It is a good course to start for anyone interested in medical device regulations

Thamer Abdullah AlArwan
Saudi Food and Drug Authority

United Kingdom

  • 42 Technology Ltd
  • AAH Pharmaceuticals Ltd
  • Abbott Diabetes Care Ltd
  • Addos Consulting
  • AKOS Limited
  • Alcon Laboratories (UK) Ltd
  • Alere International
  • Allergan
  • Allergan UK Limited
  • Alliance Healthcare
  • Alliance Pharmaceuticals Ltd
  • Almac Group LTD
  • Animalcare Ltd
  • Arecor Ltd
  • B Braun Medical Ltd
  • Bayer Healthcare
  • Bayer plc
  • BD
  • Becton Dickinson
  • Bedfont Scientific Ltd
  • Besins Healthcare
  • Bespak
  • Biogen Idec Ltd
  • BMJ Publishing Group Limited
  • Boots Pharmaceuticals
  • Bristows LLP
  • BTG
  • Cambridge Technology Centre
  • Chemidex Pharma
  • Circassia Pharmaceuticals
  • Cochlear Europe Ltd
  • ConvaTec UK Ltd
  • Cooley (UK) LLP
  • Cooley, LLP
  • Coopervision Manufacturing Ltd
  • Corin Limited
  • Covidien (UK) Commerical Limited
  • DCA Design International
  • DCA Design International Ltd
  • Depuy CMW
  • Dermal Laboratories Ltd
  • Diamond BioPharm Ltd
  • Eli Lilly & Co Ltd
  • Fresenius Medical Care (UK) Limited
  • GAMA Healthcare
  • GlaxoSmithKline
  • Glysure Limited
  • Goldenzone Ltd
  • GR Lane Health Products Ltd
  • Gregory Fryer Associates
  • Haleon
  • Hospira UK Limited
  • In-Control Consulting Ltd
  • Inivata Ltd
  • Ipsen Biopharm Ltd
  • JensonR+ Ltd
  • Johnson & Johnson
  • Johnson & Johnson Consumer Services EAME Ltd
  • Johnson & Johnson Limited
  • Johnson & Johnson Medical Ltd
  • Johnson & Johnson Medical Ltd.
  • Kent Community Health NHS Foundation Trust
  • Kimal Plc
  • Kimberly-Clark Europe Ltd
  • MacRoberts LLP
  • Marlborough Pharmaceuticals Ltd
  • Martindale Pharma
  • Meda Pharmaceuticals Limited
  • Medical Device Consultants International Ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medtrade Products Ltd
  • Medtronic Limited
  • Mentholatum Co Ltd
  • Merck Sharp & Dohme Ltd
  • Mercury Pharmaceuticals Ltd
  • MHRA
  • MHRA - Medicines & Healthcare products Regulatory Agency
  • Molnlycke Healthcare
  • MSD Ltd
  • Mundipharma International Services Ltd
  • Mundipharma Research Ltd
  • National Artificial Eye Service
  • Norgine
  • Norgine Limited
  • Norgine Ltd
  • Novartis Pharmaceuticals Limited
  • Occuity
  • Olswang
  • Olympus KeyMed Ltd
  • Organon
  • Organon Pharma (UK) Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Owen Mumford Ltd
  • P3 Medical Ltd
  • Pennine Healthcare Ltd
  • Pharmalink Consulting Ltd
  • PPD
  • Priory Analysts Limited
  • Pritek Ltd
  • Quality by Design
  • Reckitt Benckiser
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Regulis Consulting Limited
  • Renishaw plc
  • Robinson Healthcare Limited
  • Robinson Healthcare Ltd
  • RSB Projects Ltd
  • S Black Ltd
  • Sabic Innovative Plastics
  • Shire
  • Shire Pharmaceutical Ltd
  • Sinclair
  • Sinclair IS Pharmaceuticals Ltd
  • Sinclair Pharma Ltd.
  • Sinclair Pharmaceuticals
  • Smith & Nephew Wound Management
  • Smiths Medical International Limited
  • SPD Development Company Limited
  • Stanmore Implants Worldwide Limited
  • Stiefel Labs (Maidenhead) Ltd
  • Stiefel Labs (UK) Limited
  • Sunquest Information Systems (Europe) Ltd
  • Symogen Limited
  • Systagenix Ltd
  • Systagenix Ltd (an Acelity company)
  • Systagenix Wound Management
  • System C Healthcare
  • Teva Pharmaceuticals Ltd
  • Teva UK Limited
  • Teva UK Ltd
  • Teva UK Ltd.
  • Torbay Pharmaceuticals
  • Tyco Healthcare
  • UKR Regulatory Affairs Limited
  • United Therapeutics
  • United Therapeutics Europe Ltd
  • University of Edinburgh
  • University of Southampton
  • Vincent Sykes & Higham LLP
  • Vygon UK Ltd
  • Walgreens Boots Alliance Services Limited
  • Walker Filtration Ltd
  • Winthrop Pharmaceuticals UK Ltd
  • Wyeth Europa Ltd
  • Xiros Ltd


  • Acrostak
  • Biosensors Europe SA
  • CSL Behring
  • Emergent BioSolutions Berna GmbH
  • F. Hoffmann-La Roche Ltd
  • Kyphon Sarl
  • Medtronic International Trading Sarl
  • Merck Serono SA
  • Novartis Consumer Health SA
  • Roche Diabetes Care AG
  • SFL Regulatory Affairs & Scientific Communication GmbH
  • Sonova Group
  • Staar Surgical
  • TRB Chemedica International SA
  • Verfora SA
  • Zimmer GmbH


  • Ambu
  • Ambu A/S
  • Coloplast A/S
  • Ferring Pharmaceutical A/S
  • Genmab
  • Larix
  • Larix A/S
  • LEO Pharma
  • Medart A/S
  • Neurodan A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Novo Nordisk AS
  • Pierre Fabre Dermo-Cosmetique
  • Takeda Pharma A/S
  • William Cook Europe ApS


  • Amgen Europe BV
  • Astellas Pharma Europe B.V.
  • Genzyme Europe BV
  • Interdos Pharma BV
  • Mallinckrodt Medical BV
  • Medtronic BRC
  • Merck Sharp & Dohme
  • Omron Healthcare Europe BV
  • Ophtec B.V.
  • Ophtec BV
  • PGI Nonwovens BV
  • Philips Consumer Lifestyle
  • RIVM


  • Abbott Products GmbH
  • Abbvie Deutschland GmbH & Co. KG
  • Artivion
  • Bayer Pharma AG
  • Cook Deutschland GmbH
  • Grunenthal GmbH
  • Leica Microsystems
  • medac GmbH
  • Novartis
  • Paul Hartmann Ag
  • Sanofi-Aventis Deutschland GmbH
  • Takeda GmbH


  • Baxter World Trade SPRL/BVBA
  • BD International
  • Celyad
  • Cook Belgium
  • Covidien
  • GC Europe NV
  • Johnson & Johnson
  • Laboratoria Qualiphar NV/SA
  • Oystershell NV
  • Perrigo
  • QbD


  • Advanced Bionics Sarl
  • Air Liquide Santé International
  • BD
  • Becton Dickinson
  • Blue Reg Europe
  • Guerbet
  • Ipsen Ltd
  • MEDEX groupe GUERBET- à l'attention de la comptabilité fournisseurs
  • Pierre Fabre Medicament


  • Abiogen Pharma S.p.A.
  • Chiesi Farmaceutici SPA
  • Cook Italia
  • JOTEC GmbH
  • Recordati S.p.A
  • Sigea Srl

Saudi Arabia

  • Becton Dickinson
  • Becton Dickinson BV
  • Gulf Health Council
  • Saudi Food & Drugs Authority
  • Saudi Food and Drug Authority
  • SFDA


  • Boston Scientific Ireland Ltd
  • Cook Ireland Ltd
  • Merit Medical
  • Shire Pharmaceuticals Ireland Ltd

United States of America

  • AbleNet Inc
  • Baxter
  • Charter Medical, LLC
  • Johnson & Johnson
  • Volpi USA


  • AstraZeneca
  • AstraZeneca AB
  • Mölnlycke Health Care AB

United Arab Emirates

  • BD
  • BD & Company
  • Becton Dickinson BV


  • Ego Pharmaceuticals Pty Ltd
  • Nanosonics


  • Baxter AG
  • Baxter Innovations GmbH


  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Czech Republic

  • Contipro a.s.
  • Teva Czech Industries S R O


  • Det Norske Veritas
  • Weifa AS


  • Ascendis Wellness
  • Ewopharma AG


  • Rep. office Becton Dickinson BV (Netherlands)


  • Medica Ad


  • FibroTx OU




  • Primex


  • Blau Pharmaceutical Services


  • Becton Dickinson East Africa Limited

Korea, Republic Of

  • AJOU University


  • Medical Devices Administration of Montenegro


  • Becton Dickinson Polska Sp z o.o.


  • Infarmed


  • Medicines and Medical Devices Agency of Serbia


  • Becton Dickinson İth. İhr. Ltd. Şti.

Enrol or reserve

Run An Introduction to the Medical Device Regulation Live online for your team

3 days

Typical duration

Pricing from:

  • GBP 1,200
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749