Presented by
Management Forum
An Introduction to the Medical Device Regulation In-house Training
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)"
- Format: Live online
- CPD: 18 hours for your records
- Certificate of completion
- An Introduction to the Medical Device Regulation
- The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
- An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
- Managing Competence within the Medical Device Industry
- An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
- Practical Implementation of a Human Factors Study
- An introduction to Risk Management ISO 14971:2019
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.
Benefits of attending
- Learn an overview of EU regulations and the MDR
- Understand the classification and labelling system of medical devices
- Explore medical device vigilance
- Gain information on CE Marking
- Clarify drug/device combinations and devices incorporating material of animal origin
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.
This 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: vigilance
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)
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
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.
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.
Theresa Jeary
BSI
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.
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 
Senior Quality Assurance and Regulatory Affairs 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 
pharmaceutic,
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
ROCKETMEDICAL PLC
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
ROCKETMEDICAL PLC
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 
TEOXANE SA
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 
Baxter
May 8 2017
Content was very informative and the speakers were brilliant, knowledgable
Christina Obafemi
Walgreens Boots Alliance Services Limited
May 8 2017
Excellent
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 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
- Cencora
- 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
- MAGSTIM CO LTD
- 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
- 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
- ROCKETMEDICAL PLC
- 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
- XIROS PLC
Switzerland
- Acrostak
- APPLETREE AG
- 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
- TEOXANE SA
- TRB Chemedica International SA
- Verfora SA
- Zimmer GmbH
Denmark
- 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
Netherlands
- Amgen Europe BV
- Astellas Pharma Europe B.V.
- Genzyme Europe BV
- Interdos Pharma BV
- Mallinckrodt Medical BV
- Medtronic BRC
- Merck Sharp & Dohme
- MSD ORGANON
- Omron Healthcare Europe BV
- Ophtec B.V.
- Ophtec BV
- PGI Nonwovens BV
- Philips Consumer Lifestyle
- RIVM
Germany
- 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
Belgium
- Baxter World Trade SPRL/BVBA
- BD International
- Celyad
- Cook Belgium
- Covidien
- GC Europe NV
- Johnson & Johnson
- Laboratoria Qualiphar NV/SA
- Oystershell NV
- Perrigo
- QbD
France
- 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
Italy
- 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
Ireland
- Boston Scientific Ireland Ltd
- Cook Ireland Ltd
- Merit Medical
- PFIZER CONSUMER HEALTHCARE LTD
- Shire Pharmaceuticals Ireland Ltd
United States of America
- AbleNet Inc
- Baxter
- Charter Medical, LLC
- Johnson & Johnson
- Volpi USA
Sweden
- AstraZeneca
- AstraZeneca AB
- Mölnlycke Health Care AB
United Arab Emirates
- BD
- BD & Company
- Becton Dickinson BV
Australia
- Ego Pharmaceuticals Pty Ltd
- Nanosonics
Austria
- Baxter AG
- Baxter Innovations GmbH
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
- HALMED
Czech Republic
- Contipro a.s.
- Teva Czech Industries S R O
Norway
- Det Norske Veritas
- Weifa AS
Romania
- Ascendis Wellness
- Ewopharma AG
Russia
- JLT MOSCOW
- Rep. office Becton Dickinson BV (Netherlands)
Bulgaria
- Medica Ad
Estonia
- FibroTx OU
Greece
- ELPEN PHARMACEUTICAL CO.INC.
Iceland
- Primex
Israel
- Blau Pharmaceutical Services
Kenya
- Becton Dickinson East Africa Limited
Korea, Republic Of
- AJOU University
Montenegro
- Medical Devices Administration of Montenegro
Poland
- Becton Dickinson Polska Sp z o.o.
Portugal
- Infarmed
Serbia
- Medicines and Medical Devices Agency of Serbia
Turkey
- Becton Dickinson İth. İhr. Ltd. Şti.
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:
