This will result in huge savings and burden reduction for your company.

Key Features:

• Web App
• Dedicated back end
• Revision management
• QR scan and download
• Language management
• Local language recognition
• Blockchain Audit Trail

Our tools are fully compliant and ready to use.

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What Are the Main requirements for and e-IFU solutions?

Requirements on the labeling on the device or the enclosed printed IFU:
-Information on the device or in the accompanying information that a printed IFU is available and how
this can be obtained
-Information on foreseeable emergency situations
(alternative: risk assessment that no medical emergency situations are expected that would
necessitate additional safety information.)

Requirements on the content of the IFU (IFU or eIFU):
 Evidence that the device is intended for a professional user (e.g. information in IFU)
 Where a part of the instructions for use is intended to be provided to the patient, that part must be
provided in paper (e.g. special information for implant owner or an implant pass)
 The content of the eIFU shall be at least identical with the printed version (multimedia content (e.g.
video tutorial) may be provided additionally but not instead of a printed version.)

Requirement on the risk analysis and risk evaluation:
Content shall cover at least the requirement of regulation 207/2012, art. 4
The aspects mentioned in art. 4 of regulation 207/2012 should be covered thoroughly in the risk
management file. The information can either be included in a separate risk evaluation or included in
the existing risk management file.

Requirements on the website:
-Manufacturer’s contact information name, address, telephone / email
-Information how to identify the correct eIFU
e.g. how/where the unique identification of the product can be found
-Information on software- or hardware-requirements to view the eIFU
e.g. what software is required to view the eIFU and where to obtain itInformation how and within which timelines a printed version of the IFU can be obtained free of
charge – the timelines shall be maximum of 7 calendar days.
-Information in which European Union languages the information is available.
-Description that the eIFU is available in a commonly used format that can be accessed with freely
available software.
-Description how all previous versions of the eIFU are available on the website, including the date of
publication. Previous versions shall be kept available for at least 2 years after the expiry date or 15
years after placing on the market (for devices without an expiry date or implantable devices). Evidence
could be provided e.g. by screenshots of the draft website

Contractual regulations with the internet service provider (ISP) or owner of the website
Description of the measures to prevent hardware or software intrusion or tampering
e.g. description of cybersecurity measures or respective certification of the ISP
Description of availability of the website (server downtime, display errors)
e.g. contractual regulation with internet service provider on availability of the website and reaction
(times) in case of an outage.

Our tools are fully compliant and ready to use.