dokspot summary eIFU - International regulations and quality standards
In general, regulations and for eIFU Systems for medical devices and/or IVD devices require:
A that the device is intended to be used by healthcare professionals exclusively
B a risk assessment
C a process allowing that a printed IFU can be requested from the device manufacturer free of charge
International eIFU regulations
Country / Region
Regulations on digital instructions (Link)
Electronic Instructions for Use - eIFU
Medical device patient information leaflets and implant cards
Normative Instruction-IN N°4, OF June 15th, 2012
Commission Regulation 207/2012 (has been repealed, transition period until May 2024)
Commission Regulation 2021/2226 (in force as of Jan 3, 2022)
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices (MDR) - Whereas (98), Annex VI, Part B, 22., Chapter III, Article 23.1
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices (IVDR) - Annex VI, Part B, 19.
Chapter III, Article 20.1
TIBBİ CİHAZLARIN ELEKTRONİK KULLANIM TALİMATLARI HAKKINDA TEBLİĞ BİRİNCİ BÖLÜM
GUIDANCE O LABELLING REQUIREMENTS FOR MEDICAL DEVICES
FDA Blue Book Memorandum on electronic instructions for use
Medical Device User Fee and Modernization Act of 2002 - see Section 206
MTAL - Acceptance of eIFU for Medical Device a Welcome Move: MTa
Guidance Document: Guidance for the Labelling of Medical Devices
International quality standards
Details / sections
ISO13485 Third Edition 2016-03-01
Sections 4.1.6 and 7.5.6
21 CFR Part 11
Requirements of the US legal system for compliance of computer systems with electronic records and signatures.
Requirements for computer systems used for the manufacturing, supply, and operation of medical devices.
This document lists regulations and quality standards to be considered for the implementation of a medical device eIFU system. Additional manufacturer and device specific requirements apply.
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