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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.

8-10 Nov 2022

& 7-9 Feb 2023 , 17-19 May 2023 , 2-4 Aug 2023 , 6-8 Nov 2023

Book or reserve now

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: 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

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.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
8-10 Nov 2022
Live webinar
09:00-16:45
UK (London)
8-10 Nov 2022
Live webinar
09:00-16:45
UK (London)
GBP 1,549 1,249
EUR 2,229 1,809
USD 2,524 2,056
Until 4 Oct*
Enrol now
to attend Live webinar
7-9 Feb 2023
Live webinar
09:30-17:15
UK (London)
7-9 Feb 2023
Live webinar
09:30-17:15
UK (London)
GBP 1,649 1,349
EUR 2,359 1,939
USD 2,669 2,201
Until 3 Jan 23*
Enrol now
to attend Live webinar
17-19 May 2023
Live webinar
09:30-17:15
UK (London)
17-19 May 2023
Live webinar
09:30-17:15
UK (London)
GBP 1,649 1,349
EUR 2,359 1,939
USD 2,669 2,201
Until 12 Apr 23*
Enrol now
to attend Live webinar
2-4 Aug 2023
Face-to-face, Rembrandt Hotel London
09:00-17:15
UK (London)
2-4 Aug 2023
Face-to-face
Rembrandt Hotel London
09:00-17:15
UK (London)
GBP 1,999 1,699
EUR 2,869 2,449
USD 3,269 2,801
Until 28 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 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
6-8 Nov 2023
Live webinar
09:00-17:15
UK (London)
6-8 Nov 2023
Live webinar
09:00-17:15
UK (London)
GBP 1,649 1,349
EUR 2,359 1,939
USD 2,669 2,201
Until 2 Oct 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

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

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • Abbott Products GmbH
  • Abbvie Deutschland GmbH & Co. KG
  • Allergan UK Limited
  • Alliance Healthcare
  • Ascendis Wellness
  • Baxter AG
  • Baxter World Trade SPRL/BVBA
  • Blue Reg Pharma Consult
  • ConvaTec UK Ltd
  • Cook Deutschland GmbH
  • Cooley (UK) LLP
  • Ewopharma AG
  • Guerbet
  • Infarmed
  • Medicines and Medical Devices Agency of Serbia
  • Merck Serono SA
  • Mölnlycke Health Care AB
  • National Artificial Eye Service
  • P3 Medical Ltd
  • PGI Nonwovens BV
  • PPD
  • Rep. office Becton Dickinson BV (Netherlands)
  • Shire
  • Sonova Group
  • Symogen Limited
  • Takeda Pharma A/S
  • Teva UK Ltd
  • Teva UK Ltd.
  • Vygon UK Ltd
  • Zimmer GmbH

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, Aug 22

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 22

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 22

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, May 22

Great presentations, workshops

Marie-Antoinette Serraille, Regulatory Affairs Specialist, BD, May 22

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 22

I thought the presentations were good, Janette in particular, some courses will just read what's on the slides, but this training had a lot of discussion and supplementary info which wasn't necessarily written word for word on the slides, so great presentation style. Very useful.

Scott Waterson, Senior Quality Engineer, Teva Pharmaceuticals, Nov 21

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, Nov 21

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