Presented by
Management Forum

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.

10-12 Nov 2021 + 4 more dates

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  • Format: Live online, Classroom
  • CPD: 18 hours for your records
  • Certificate of completion

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.

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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?

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

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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.

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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.

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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.

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Book An Introduction to the Medical Device Regulation Live online/Classroom training

10-12 Nov 2021

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 10983

  • GBP 1,549
  • EUR 2,229
  • USD 2,524

Limited places remaining

In your basket 

8-10 Feb 2022

Classroom
London venue TBC

09:00-17:15 UK (London)
Course code 11433

  • GBP 1,549 1,849
  • EUR 2,169 2,589
  • USD 2,416 2,884

Until 04 Jan

  • 3 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

18-20 May 2022

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 11624

  • GBP 1,249 1,549
  • EUR 1,809 2,229
  • USD 2,056 2,524

Until 13 Apr

In your basket 

1-3 Aug 2022

Classroom
London venue TBC

09:00-17:15 UK (London)
Course code 11845

  • GBP 1,549 1,849
  • EUR 2,169 2,589
  • USD 2,416 2,884

Until 27 Jun

  • 3 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

8-10 Nov 2022

Live online

09:00-17:15 UK (London) (UTC+00)
10:00-18:15 Paris (UTC+01)
04:00-12:15 New York (UTC-05)
Course code 11759

  • GBP 1,249 1,549
  • EUR 1,809 2,229
  • USD 2,056 2,524

Until 04 Oct

In your basket 

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


Excellent!! Speakers were very knowledgeable and approachable.

May 12 2021

Morag Appleton
Pharmacovigilance Manager, Dermal Laboratories Ltd

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 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 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

UK

  • 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
  • Animalcare Ltd
  • B Braun Medical Ltd
  • Bayer Healthcare
  • Bayer plc
  • BD
  • Becton Dickinson
  • Besins Healthcare
  • Bespak
  • Biogen Idec Ltd
  • BMJ Publishing Group Limited
  • Boots Pharmaceuticals
  • Bristows LLP
  • BTG
  • Cambridge Technology Centre
  • Circassia Pharmaceuticals
  • Cochlear Europe Ltd
  • ConvaTec UK Ltd
  • Cooley (UK) LLP
  • Cooley, LLP
  • Coopervision Manufacturing Ltd
  • 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
  • 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
  • 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
  • Olswang
  • Olympus KeyMed Ltd
  • Organon Pharma (UK) Limited
  • Otsuka Pharmaceutical Europe Ltd
  • P3 Medical 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 IS Pharmaceuticals Ltd
  • 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
  • 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
  • TRB Chemedica International SA
  • Verfora SA
  • Zimmer GmbH

Denmark

  • 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

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

Germany

  • Abbott Products GmbH
  • Abbvie Deutschland GmbH & Co. KG
  • Bayer Pharma AG
  • Cook Deutschland GmbH
  • Grunenthal GmbH
  • medac GmbH
  • Novartis
  • Sanofi-Aventis Deutschland GmbH
  • Takeda GmbH

France

  • Advanced Bionics Sarl
  • Air Liquide Santé International
  • Blue Reg Europe
  • Guerbet
  • Ipsen Ltd
  • Pierre Fabre Medicament

Ireland

  • Boston Scientific Ireland Ltd
  • Cook Ireland Ltd
  • Merit Medical
  • PFIZER CONSUMER HEALTHCARE LTD
  • Shire Pharmaceuticals Ireland Ltd

Italy

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

Saudi Arabia

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

United States of America

  • AbleNet Inc
  • Baxter
  • Johnson & Johnson
  • Volpi USA

Sweden

  • AstraZeneca
  • AstraZeneca AB
  • Mölnlycke Health Care AB

United Arab Emirates

  • BD
  • BD & Company
  • Becton Dickinson BV

Austria

  • Baxter AG
  • Baxter Innovations GmbH

Czech Republic

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

Norway

  • Det Norske Veritas
  • Weifa AS

Russia

  • JLT MOSCOW
  • Rep. office Becton Dickinson BV (Netherlands)

Australia

  • Ego Pharmaceuticals Pty Ltd

Bulgaria

  • Medica Ad

Croatia

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

Estonia

  • FibroTx OU

Greece

  • ELPEN PHARMACEUTICAL CO.INC.

Israel

  • Blau Pharmaceutical Services

Kenya

  • Becton Dickinson East Africa Limited

Montenegro

  • Medical Devices Administration of Montenegro

Poland

  • Becton Dickinson Polska Sp z o.o.

Portugal

  • Infarmed

Romania

  • Ewopharma AG

Serbia

  • Medicines and Medical Devices Agency of Serbia

Turkey

  • Becton Dickinson İth. İhr. Ltd. Şti.

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Multiple colleagues?
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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy