eIFU Smart Solutions
eIFU Solution for Medical Device & Pharma
We provide an innovative eifu tool to manage your IFU digitally and in full compliance with MDR/IVDR regulation for your medical device and in vitro diagnostic devices.
This will result in huge savings and burden reduction for your company. Try for free our eIFU complete solution and test our service.
What our tool offers
Smart eIFU Platform
What does your company spend on packaging, paper, printing, logistics and the management of all that?
Huge savings and Burden reduction
Save Paper
and Costs
Fully Compliant and Ready to Use
eIFU Platform Key features:
- Web App
- Dedicated back end
- Revision management
- QR scan and download
- Personalized front end
- Language management
- Local language recognition
- Blockchain Audit Trail
Compliant Solution
Our software solution is compliant to FDA part 11, ISO 27000, IEC 62304 and MDR
DATA INTEGRITY ISSUE
Counterfeit Document Threat
We have developed an effective and easy-to-use document management tool. The tool allows storing documents of any kind into a safe database backed by blockchain allowing to make the certificate tamper-proof and immutable.
Counterfeit documentation is a common issue in daily business, especially in time of urgent need.
A big wave of fake documents
The market has seen a big wave of fake certificates being issued during the peak of the pandemic in April and May 2020.
Our Solution
Using blockchain makes altering documentation impossible for hackers or criminals. Audit trail is maintained in compliance with 21 CFR Part 11.
What Are the Main requirements for and eIFU 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)
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 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.
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.
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).
Requirement on the risk analysis and risk evaluation:
Content shall cover at least the requirement of Implementing Regulation (EU) 2021/2226. Aspects of Implementing Regulation 2021/2226 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
- 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.
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.