Interested participants from other time zones are invited to contact us about the course at [email protected].
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The shift from traditional paper-based Instructions for Use (IFU) to Electronic Instructions for Use (eIFU) is transforming how manufacturers provide critical product information to users, regulators, and healthcare professionals. eIFUs enable faster access to updated content, reduce environmental impact, and align with digital expectations in today’s medical and technical fields.
This training will introduce participants to the concept, regulatory framework, and practical implementation of eIFUs, with a focus on compliance under the EU Medical Device Regulation (MDR) as well as applicable Commission Implementing Regulations (EU No 207/2012 and updates).
Key Topics Covered
- Definition and Purpose of eIFU: What qualifies as an eIFU and why it matters.
- Regulatory Requirements conditions under which eIFUs can replace paper versions, including risk assessment, device types, and user needs.
- Implementation Considerations to design, accessibility, version control, and multilingual requirements.
- Benefits of eIFU incl. real-time updates, cost efficiency, sustainability, and improvement of user accessibility.
- Challenges and Best Practices addressing digital access issues, user acceptance, and audit readiness.
Benefits of this Training
- Gain clarity on regulatory expectations for eIFU
- Learn how to assess eligibility of devices for eIFU use
- Understand practical steps for implementation and compliance
- Explore case studies and best practices for smooth adoption
- Strengthen readiness for audits and inspections relating to eIFU
By the end of this session, participants will understand not only the “what” and “why” of eIFU but also the “how” ensuring compliant, user-friendly, and effective deployment of electronic instructions.
Target Audience
This training is intended for:
- Regulatory Affairs and Quality Assurance Mangers
- Product Development and Labeling teams
- Clinical, Safety, and Post-Market Surveillance professionals
- Project Managers overseeing digital transformation initiatives
- Management responsible for regulatory strategy and compliance
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR and Regulations (EU No 207/2012).
Auditors
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Klaus Lindenberg
Auditor
Klaus Linderberg graduated from Fachhochschule Lübeck as Diplom Ingenieur (FH) in Biomedical Technology. With extensive experience across various companies in Germany’s medical device sector, he has built a strong foundation in quality and regulatory compliance. He has been working as a Lead Auditor and Technical Expert for medical device Quality Management, specializing in regulatory standards and audits. His professional background is supported by certifications relevant to medical device quality assurance and auditing.