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MDF5 Understanding Instructions for Use of Medical Devices and Providing Support in Their Drafting
Who it is for
This workshop is designed for medical writers who are new to medical device regulatory writing or who would like to strengthen their understanding of Instructions for Use (IFUs) under the EU Medical Devices Regulation (MDR 2017/745), including relevant MDCG guidance and current regulatory expectations. It is also suitable for writers transitioning from pharmaceutical to medical device documentation.
What it covers
By the end of this workshop, participants will be able to:
• Understand the regulatory requirements governing IFUs under EU MDR 2017/745
• Identify the key sections and mandatory content of an IFU
• Recognize how information is sourced from clinical, technical, usability, and risk management documentation
• Apply principles of clear, user-centered writing to improve readability and usability
• Contribute effectively to the planning, drafting, review, and maintenance of IFUs
• Recognize common pitfalls and implement best practices to improve document quality
Currently working as a Senior Medical Writing Manager at Trilogy Writing & Consulting, she has over 25 years of experience in writing, editing, and managing medical and scientific documentation for diverse clients and audiences. Laura is EMWA-certified and holds multiple certificates in linguistics, pharmacology, medical devices, and clinical research. She has served EMWA in different roles: Professional Education Committee member and chair, as well as a member of the Executive Committee.
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Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.