eIFU resources

Learn more about the requirements that guide the development of your eIFU

Regulations & Guidelines

European Union
United States
Canada
Brazil
Saudi Arabia
Australia
International Standards

Regulations and Guidelines

  • eIFU guidance for IVDs

MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices.

  • eIFU regulation for MDs (under MDR)

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

  • eIFU regulation for MDs (under MDD)

Commission Regulation (EU) No 207/2012 of 9 March 2013 on electronic instructions for use of medical devices.

  • EU regulation for IVDs

Regulation (EU) 2017/746 of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

  • EU regulation for MDs

Regulation (EU) 2017/745 of 5 April 2017 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

  • GDPR

Regulation (EU) 2016/679 of 25 May 2018 on Regulation on the protection of natural persons regarding the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive).

Regulations and Guidelines

  • eIFU guidance for IVDs

MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices.

  • eIFU regulation for MDs (under MDR)

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

  • eIFU regulation for MDs (under MDD)

Commission Regulation (EU) No 207/2012 of 9 March 2013 on electronic instructions for use of medical devices.

  • EU regulation for IVDs

Regulation (EU) 2017/746 of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

  • EU regulation for MDs

Regulation (EU) 2017/745 of 5 April 2017 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

  • GDPR

Regulation (EU) 2016/679 of 25 May 2018 on Regulation on the protection of natural persons regarding the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive).

US regulations (FDA)

  • FDA regulation for MDs & IVDs

Federal Food, Drug, and Cosmetic Act (FD&C Act) – Chapter V: Drugs and Devices – Part A Drugs and Devices and Part D Dissemination of Treatment Information.

  • FDA regulation for MDs & IVDs on labeling and advertisements

U.S. Code, Title 21, Chapter 9, subchapter V, Part A, §352 Misbranded drugs and devices.

  • FDA regulation on use of electronic records & signatures

U.S. Code, Title 21, Chapter 11, Electronic records; electronic signatures.

  • FDA regulation to authorize eIFU

Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities.

US regulations (FDA)

  • FDA regulation for MDs & IVDs

Federal Food, Drug, and Cosmetic Act (FD&C Act) – Chapter V: Drugs and Devices – Part A Drugs and Devices and Part D Dissemination of Treatment Information.

  • FDA regulation for MDs & IVDs on labeling and advertisements

U.S. Code, Title 21, Chapter 9, subchapter V, Part A, §352 Misbranded drugs and devices.

  • FDA regulation on use of electronic records & signatures

U.S. Code, Title 21, Chapter 11, Electronic records; electronic signatures.

  • FDA regulation to authorize eIFU

Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities.

US guidance documents (FDA)

  • Using Electronic Means to Distribute Certain Product Information.

 Guidance for Industry; March 2006.

  • Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals

March 2010.

US guidance documents (FDA)

  • Using Electronic Means to Distribute Certain Product Information.

 Guidance for Industry; March 2006.

  • Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals

March 2010.

  • Notice 10-123767-875: Guidance for the labelling of Medical Devices, not including in vitro diagnostic devices.
  • Normative Instruction – IN No. 4, of June 15th 2012.
  • SFDA/MDS Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices (MDS – G41, of September 29, 2019)
  • Electronic Instructions for Use – eIFU: For professional users of medical devices (including IVDs) – v1.0 August 2018 (Therapeutic Goods Administration).

SDLC standard used for the development of the IFUcare website

  • IEC 62304:2006: Medical device software – Software life cycle processes

ISO 13485

  • Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

ISO 14971

  • Medical Devices – Application of Risk Management to Medical Devices

Frequently Asked Questions

eIFU stands for “electronic instructions for use“, but the term encompasses more than just these documents. It also includes the online distribution of other regulatory documents, such as certificates of analysis, safety data sheets, and quality control documents.

eIFU can be made available via a manufacturer’s website but due to the strict regulations, these websites must be validated for compliance. IFUcare removes this burden and offers a pre-validated website, that still matches your corporate identity. Moreover, maintenance and continued compliance are ensured.

Using eIFU has many benefits over paper instructions: in addition to reducing packaging which makes your products more environmentally friendly, it allows you to make faster changes to your documents as needed, reduces the risk associated with product recalls, saves the cost of paper and the service costs around updating your documents, and keeps you stay up-to-date with the technological demands of the modern world.

Discover all benefits here.

Medical devices and in vitro diagnostics are required to be provided with an IFU. Depending on the country and product type, they can be on paper or electronic. Products which fall into these categories can have eIFU. Contact us for more details.

Not at all! We have a team of support care staff who are available to provide you with training, access to manuals (for using the website as well as for implementing eIFU), access to a test site to play around in before using the ‘real’ account, and to answer any questions you may have.

That depends on the countries in which your products will be sold. See the top of this page for a list of common regulations, directives and guidelines for different countries. The IFUcare team is well versed on the regulations around MDs and IVDs, and will make sure that the eIFU site that we create for your company will be compliant for all market countries that accept eIFU. If you need expert advice, do not hesitate to contact us.

The location of your company does not determine eIFU acceptance. Instead, you should review the local regulations in the countries where you sell your products to evaluate whether they accept electronic instructions as replacement for paper.

To find out where eIFU are accepted, please contact us here.

It could be possible, but you will have to ensure that your website complies to the strict requirements as described in various regulations and guidances, and becomes integral part of your quality management system (QMS).

The combined impact on the website and your organisation cannot be underestimated:

  • The website must be kept in a validated state (change control)
  • The website must be protected against intrusion in an ever-changing threat spectrum  
  • Website usability must be verified to ensure smooth and correct access to information
  • Supporting services and systems must be in place to supply users with paper copies upon request, free of charge
  • Regulatory intelligence must be aligned with IT services to ensure that the website remains in compliance with latest regulations

Understanding the tremendous resources needed to meet all of these requirements, it is easy to see that it is more straightforward and cost-effective to outsource your eIFU to the off-the-shelf solution of IFUcare. Partnering with us provides you with the peace of mind that these challenges are under control, allowing you to focus on your core business.

IFUcare is a service of Qarad. Qarad has an ISO 13485 certified quality management system (QMS), ISO 27001 certification for information security, and we follow the software development life cycle (SDLC) procedure based on the EN/IEC 62304 standard.

IFUcare controls software developments and validation by working according to a very strict software development life cycle (SDLC) procedure, which is based on the EN/IEC 62304 standard. 

Download our practical steps to ensure a successful eIFU implementation here.

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