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 part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Agenda
Day 1
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
Day 2
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
Day 3
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
Speakers
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
NAMSAJanette 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 ahs 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.
Mr Will Burton,
Director ,
Russell Square Quality Representatives (RSQR) LtdWill 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.
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)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 a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
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.
