Introduzione
Instructions for use (IFUs) are part of the labeling documentation for medical devices and, as such, are subject to MDR regulatory requirements.
Instructions for use are not required for Class I and Class IIa devices if such devices can be used safely without any such instructions and unless otherwise specified in the MDR. Still, all other devices do need to have their own IFUs.
Understanding where each piece of information in the IFUs comes from is not an easy task and newbies to the world of medical devices would benefit from learning the intricacies of this document before working on any other related documentation.
Also, as a medical device professional, you may even need to provide some of the content in the IFUs for their final version: such as ‘possible adverse events’ or ‘cleaning instructions’. Thus, you may also benefit from the writing recommendations targeting IFUs.
Finally, IFUs are subject to predefined review cycles and depend on several other input documents.
This workshop will give you profound insights into the regulatory requirements for IFUs, best practice recommendations on how to draft IFUs, and insights into common pitfalls and tips on how to avoid them.
- Regulatory framework: EU MDR 2017/745 requirements and definitions
- Content and structure of the Instructions for Use
- Where do all those contents come from? Legacy devices vs new devices
- Recommendations for the writing process: Tips to improve writing of the IFUs
- Usability and readability
- Images, photos and symbols
- Where else is the content of the IFUs used and how it needs to be used
This course is intended for medical device professionals with little or no experience in medical devices Instructions for Use, under the Medical Devices Directive 93/42/EEC (MDD) or under the Medical Devices Regulation 2017/745 (MDR).
Participant experience
We will assume that participants have basic knowledge of the directives and regulations governing medical devices, such as the MDD and MDR.
Lecturers will deliver short presentations on the programme topics. Questions and subsequent discussions are welcome at any time during the workshop.
A series of polling questions will be used to illustrate participants’ ideas and perceptions on the topics presented. In breakout rooms, small groups of participants will be given a common workshop-related ‘problem’ to discuss and suggest ideas to solve the proposed problem.
Docente/i
Katharina Friedrich
Katharina Friedrich is a medical writer with experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant with focus on orthopedic and cardiovascular devices. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic and trauma surgery.
Laura C Collada Ali
Laura is an accomplished Medical Writing Manager with a proven track record of efficiently overseeing the complete process and timely delivery of critical study documents. Her expertise encompasses a wide range of materials, including protocols, informed consent documents, clinical study reports (CSRs), and other essential study materials, particularly within the realm of pharmaceuticals. She also lends her support to medical device manufacturers in drafting crucial documents such as clinical evaluation reports, post-market clinical follow-up reports, and summaries of safety and clinical performance. Laura’s passion for clear and inclusive language extends beyond her professional duties, as she has a keen interest in public-facing writing. With over 24 years of experience, she has successfully collaborated with pharmaceutical companies and medical device manufacturers across various specialties, including oncology, orthopaedics, cardiology, dermatology, infectious diseases, and more. She regularly runs workshops on her expertise domains. Her active involvement in the European Medical Writers Organization (EMWA), where she serves as an Educational Officer and member of the Executive Committee, underscores her commitment to the field of medical writing and continuous professional development.
This online training consists of 1 module:
15 September 2022 – from 9:00 am to 1:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 495,00* (until 18 August 2022)
Ordinary: € 625,00*
Freelance – Academy – Public Administration**: € 370,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.