eIFU & Implant Card Compliance Platforms
eIFU is governed by EU Implementing Regulation 2021/2226 (amended by 2025/1234). Implant cards: MDR 2017/745 Article 18.
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500+
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Compare eIFU & Implant Card Platform Providers
For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.
Rimsys
Rimsys offers a unified Regulatory Information Management (RIM) platform purpose-built for MedTech, digitizing and automating regulatory activities to accelerate market entry and reduce compliance risks.
Rimsys provides a holistic RIM software solution designed specifically for the MedTech industry, aiming to digitize and automate all regulatory activities within a single, cloud-based platform. Their solution helps regulatory affairs teams enhance efficiency, reduce compliance risks, and expedite product launches by centralizing regulatory information, managing workflows, and automating processes. The platform supports the creation and management of a single source of truth for registrations, certificates, submission documents, technical files, UDI, and correspondence with health authorities, ensuring consistent and up-to-date information across the organization. Rimsys is particularly focused on addressing the complexities of global regulatory landscapes, including EUDAMED compliance, by offering tools for UDI data management, automated verification, and pre-configured submission processes, backed by expert guidance.
Website:
rimsys.io
HQ:
New York, US
Languages:
English
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Reed Tech
Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services for global health authorities.
LexisNexis Reed Tech is a leading provider of information-based solutions and services for the Life Sciences industry. They specialize in managing medical device Unique Device Identification (UDI) product data for global health authorities, offering expertise in UDI data submission and product lifecycle management. Their services include outsourced Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Reed Tech serves a wide range of clients, from small to mid-size producers and distributors to the largest global leaders in the pharmaceutical and medical device sectors. With a focus on regulatory compliance and data accuracy, Reed Tech's SingleSource™ platform for Medical Devices ensures UDI data is managed in a compliant SaaS environment, with scalability for increased volume and global health authorities. They actively support UDI channels for US FDA, China NMPA, South Korea MFDS, and are staging for EU EUDAMED and Australia UDID, demonstrating their commitment to global regulatory support.
Website:
go.reedtech.com
HQ:
Horsham, US
Languages:
English
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IFUcare (Qarad / QbD Group)
IFUcare, part of QbD Group, offers a full-service eIFU SaaS platform for IVD and MD manufacturers. They provide regulatory expertise, implementation support, and a multilingual call center to ensure compliance and efficiency.
IFUcare, a service of QbD IVD | Qarad, specializes in providing a comprehensive eIFU (electronic Instructions for Use) solution for medical device (MD) and in vitro diagnostic (IVD) manufacturers. As pioneers in this field, they help companies transition from paper IFUs to online accessibility, reducing risk and saving time and money in a compliant manner. Their validated SaaS platform is backed by regulatory experts and a full-service compliance team, ensuring adherence to EU/FDA regulations. IFUcare offers implementation support, handles regulatory changes, and perfects the validation process to meet Notified Body expectations. They are ISO 13485 and ISO 27001 certified. To address regulatory requirements for providing paper copies upon request, IFUcare includes a worldwide call center available 24/7. They are part of the QbD Group, a multinational organization with over 650 employees offering a wide range of services across the entire product lifecycle for life science companies.
Website:
ifucare.io
HQ:
Antwerpen, Belgium
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting:
SaaS
Features:
Multilingual, Validation Pack
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Meddevo eIFU
Meddevo eIFU offers an automated Electronic Instruction for Use (eIFU) platform for medical device manufacturers. Streamline your regulatory documentation and publishing processes with their zero-maintenance solution.
Meddevo eIFU provides a next-generation platform for managing and publishing Electronic Instructions for Use (eIFU), Declarations of Conformity (DoCs), Certificates, and MSDS. Designed for the medtech industry, it automates technical documentation and digitalizes regulatory affairs processes, reducing the regulatory burden by over 50%. Their solution integrates seamlessly with the Meddevo eTD (Technical Documentation) system, enabling automatic publishing of approved documents without manual updates. This zero-maintenance approach ensures compliance and efficiency. The platform offers a user-first experience with a beautifully designed, multi-language public website for end-users, featuring easy navigation, QR code generation, and search capabilities for REF Codes, Name, and UDI-DI. Meddevo eIFU supports full product and multi-language document management with role-based publishing. Launching a compliant eIFU site takes under 5 minutes, requiring no IT intervention. The platform is built on secure, certified servers (ISO 27001/27017/27018/9001) and is pre-validated according to ISO/TR 80002-2, with options for customization and delta validation. They cater to all medical device risk classes and offer a REST API for system integration.
Website:
meddevo.com
Languages:
English, German, French
Pricing model:
Custom pricing
Starting from:
USD 0
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack
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DDi (Visu eIFU)
DDi (Visu eIFU) provides electronic Instructions for Use (eIFU) solutions for the eIFU platform. They specialize in delivering digital documentation to enhance user access and compliance.
DDi (Visu eIFU) is a specialized provider within the eIFU platform, focusing on the delivery of electronic Instructions for Use (eIFU). Their core offering revolves around making critical product information accessible digitally, streamlining processes for manufacturers and end-users alike. By leveraging the eIFU platform, DDi (Visu eIFU) ensures that users can easily access up-to-date and compliant documentation. This digital approach not only improves user experience by providing readily available information but also supports regulatory compliance and reduces the environmental impact associated with traditional paper-based manuals. Their expertise in eIFU solutions positions them as a key partner for companies seeking to modernize their product support and information dissemination strategies. DDi (Visu eIFU) is committed to facilitating efficient and effective communication of essential product guidance through advanced digital means.
Website:
ddismart.com
Languages:
English
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack, Implant Card
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eIFU.com (enLabel Global Services)
enLabel Global Services provides integrated packaging management (IPM) solutions and e-labeling/eIFU software for highly-regulated global industries. Their platform simplifies compliance and global marketability for product labeling and documentation.
enLabel Global Services, Inc. is a technology and consulting services company headquartered in Boston, MA, specializing in Integrated Packaging Management (IPM) solutions for highly-regulated global industries such as Medical Device, Biotech, Pharmaceutical, Aerospace, and Petro/Chemical. Their flagship IPM platform is designed to integrate the design, content management, and execution of product branding, labeling, packaging, and documentation. This comprehensive software system aims to ensure regulatory compliance and facilitate global marketability for clients' products. The platform supports a uniform architecture for unsurpassed global packaging solutions, helping clients achieve zero-defect packaging. Key features include a robust Design module for consistent label creation, an innovative Workflow module for global review and approval processes, and an Execution module enabling web-based printing and relabeling worldwide. enLabel also offers e-labeling/eIFU software, providing a dedicated site for customers to access product information and media like Instructions for Use, Labels, Manuals, Brochures, Videos, and 3D CAD Files in a compliant and convenient manner. As a single-source provider, enLabel designs, develops, deploys, maintains, and supports all its products in-house. They are committed to understanding client requirements and exceeding expectations with innovative, reliable, and highly configurable off-the-shelf software solutions built for compliance.
Website:
enlabel.com
HQ:
Boston, US
Languages:
Multilingual
Response SLA:
24 hours
Pricing model:
Custom pricing
Hosting:
SaaS
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Innovatum (eLabeling / eIFU + ePIC)
Cruxi offers an AI-powered platform simplifying medical device regulatory submissions to the FDA and global markets. They provide 14 services from device classification to final submission packages.
Cruxi provides an AI-powered platform designed to streamline medical device regulatory submissions. Their services cover the entire process, from initial device classification to final submission packages for FDA and global markets. They offer 14 distinct regulatory services, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), and IDE Submissions. The platform leverages intelligent automation, automated compliance checks, and expert guidance to simplify complex regulatory pathways. Cruxi aims to be a comprehensive solution for all regulatory needs, utilizing AI workflows to enhance efficiency and compliance for medical device manufacturers.
Website:
innovatum.com
HQ:
US
Languages:
English
Pricing model:
Custom pricing
Hosting:
SaaS
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MEDELIA (RealBit) eIFU module
RealBit is a technology partner specializing in custom software development, offering solutions for digital transformation, particularly in the medical device sector with their eIFU module.
RealBit is a software house that acts as a technology partner for businesses undergoing digital transformation. They offer a range of IT services, including consulting, design, and custom software development tailored to specific client needs. Their expertise extends to providing "turnkey" solutions for the industrial and medical sectors. A key offering is the MEDELIA medical suite, which includes the eIFU module designed to manage electronic Instructions for Use (IFU) for Medical Devices (MD) and In Vitro Diagnostics (IVD). This solution simplifies IFU management, ensuring regulatory compliance and offering benefits like cost reduction, time efficiency, and sustainability. RealBit emphasizes a strategic approach to digitalization, understanding the complexities and potential hidden costs involved. They aim to provide comprehensive software solutions that not only address immediate needs but also prevent future complications, ensuring a strong return on investment and maintaining a competitive advantage for their clients.
Website:
realbit.it
HQ:
Vercelli, IT
Languages:
English, German, French, Italian
Pricing model:
Custom pricing
Hosting:
Hybrid
Features:
Multilingual, QR/UDI Linking, Implant Card
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Alysidia e-IFU Solutions
Alysidia e-IFU Solutions provides a digital platform for electronic Instructions for Use (e-IFU), enhancing accessibility and compliance for medical device manufacturers.
Alysidia e-IFU Solutions offers a specialized digital solution for managing and distributing electronic Instructions for Use (e-IFU). Their platform is designed to help medical device manufacturers meet regulatory requirements and improve user access to critical product information. By digitizing IFUs, Alysidia facilitates easier updates, broader distribution, and a more sustainable approach compared to traditional paper-based manuals. The company focuses on ensuring compliance and enhancing the user experience for both manufacturers and end-users of medical devices. Their services are crucial for companies navigating the complex landscape of medical device regulations and digital transformation.
Website:
alysidia.com
HQ:
Berlin, Germany
Languages:
English
Pricing model:
Custom pricing
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack, Implant Card
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MakroCare eIFU Services
MakroCare eIFU Services offers AI-powered regulatory platform for medical device submissions. Streamline FDA 510(k), De Novo, and PMA with expert guidance and automated compliance.
MakroCare eIFU Services provides an AI-powered regulatory platform designed to streamline medical device submissions. Their services cover a comprehensive range of FDA and global market needs, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, Humanitarian Device Exemptions (HDE), and IDE Submissions. The platform utilizes AI-powered workflows, automated compliance checks, and expert guidance to simplify the regulatory process. They offer solutions for traditional 510(k) submissions with a 90-day FDA review, and support for novel, low/moderate risk devices, including the mandatory eSTAR use from October 1, 2025. MakroCare eIFU Services aims to be an intelligent, all-in-one platform for all your regulatory needs, ensuring efficiency and accuracy at every step.
Website:
makrocare.com
HQ:
US
Languages:
English
Pricing model:
Custom pricing
Hosting:
SaaS
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GlobalCompliance Solutions Pro
Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.
Website:
globalcompliance-solutions.com
HQ:
Boston, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack, Implant Card
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MedReg International Pro
Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.
Website:
medreg-international.com
HQ:
London, UK
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack, Implant Card
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Regulatory Excellence Partners Pro
Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.
Website:
regulatoryexcellence.com
HQ:
San Francisco, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting:
SaaS
Features:
Multilingual, QR/UDI Linking, Validation Pack, Implant Card
View Profile & Get Quote
Comprehensive Buyer's Guide
1. Who Needs an eIFU Platform?
Medical device manufacturers placing devices on the EU market may choose to provide Instructions for Use (IFU) electronically instead of printing paper copies with each device[1].
This requirement applies to:
- Medical device manufacturers wanting to reduce printing costs while maintaining compliance
- Manufacturers needing to provide IFU in multiple languages
- Companies with implantable devices requiring implant card support (MDR Article 18)
- Organizations needing to manage IFU versions and obsolescence
Note: eIFU is optional—you can still provide paper IFUs. However, eIFU can reduce costs, enable faster updates, and support multilingual distribution more efficiently.
References
- EU Implementing Regulation 2021/2226 (European Union) — 2021-12-14
2. How eIFU Compliance Works
eIFU (electronic Instructions for Use) allows manufacturers to provide IFU electronically instead of printing paper copies. Key requirements under EU Regulation 2021/2226[1]:
- Secure portal: IFU must be accessible via a secure, protected website
- Paper-on-request: If any user requests a paper copy, you must provide it free of charge within 7 calendar days
- Multilingual support: IFU must be available in all required EU languages
- Version management: Obsolete versions must be available on request (after 2025/1234 amendment)
- Retention: IFU must be retained for 10-15 years depending on device type
Implant cards: MDR Article 18 requires implant cards for implantable devices to include the manufacturer website and UDI identifiers. Many teams link the implant card QR code or URL to a controlled eIFU portal.
References
- EU Implementing Regulation 2021/2226 (European Union) — 2021-12-14
- MDR 2017/745 Article 18 (European Union) — 2017-04-05 — Article 18
3. What Services Are Typically Included?
eIFU platforms typically offer:
- Hosting: Secure, accessible eIFU portal (SaaS, self-hosted, or hybrid)
- Document management: Upload, version control, multilingual support
- Paper-on-request fulfillment: Some platforms include fulfillment services, others provide software-only
- QR/UDI linking: Generate QR codes, link to UDI identifiers for implant cards
- Validation packs: IQ/OQ/PQ documentation for Notified Body audits
- Implant card support: Full support or indirect (QR/URL) linking
- Compliance features: Security, accessibility, retention management
4. What Affects Pricing?
eIFU platform pricing varies based on:
- Hosting model: SaaS (monthly subscription) vs. self-hosted (one-time license)
- Number of devices: Per device or per SKU pricing
- Paper fulfillment: Included service vs. software-only (you handle logistics)
- Features: Basic hosting vs. advanced features (validation packs, implant card support, etc.)
- Languages: Number of languages supported
- Volume: Number of IFU documents, updates, page views
Pricing models: Most providers use per-device, per-SKU, or monthly subscription models. Enterprise solutions are typically quote-based.
5. How to Choose a Provider
Key factors to consider:
- Paper fulfillment: Do you need included service or software-only?
- Implant card support: Do you need full support or indirect (QR/URL) linking?
- Validation packs: Do you need IQ/OQ/PQ documentation for Notified Body audits?
- Hosting: SaaS, self-hosted, or hybrid?
- Multilingual: How many languages do you need?
- Uptime SLA: What is the uptime guarantee and security posture?
- Version management: How do they handle obsolete versions?
Frequently Asked Questions
Q1: What is the eIFU regulation in the EU?
EU Implementing Regulation 2021/2226 (amended by 2025/1234) governs electronic Instructions for Use (eIFU) in the EU. It requires secure, accessible portals protected against unauthorized access; paper-on-request fulfillment within 7 calendar days at no cost; multilingual support for required EU languages; version/obsolescence management (obsolete versions on request after 2025/1234); and retention for 10-15 years depending on device type.
References
- EU Implementing Regulation 2021/2226 (European Union) — 2021-12-14
Q2: Do I still need paper IFUs?
Yes, but only on request. If any user requests a paper copy, you must provide it free of charge within 7 calendar days. eIFU allows you to reduce printing costs while maintaining compliance.
Q3: What does "paper on request within 7 days" mean?
Under EU Regulation 2021/2226, if any user requests a paper copy of the IFU, you must deliver it free of charge within 7 calendar days. Some platforms include fulfillment services, while others provide software-only solutions where you handle logistics yourself.
References
- EU Implementing Regulation 2021/2226 (European Union) — 2021-12-14
Q4: How do implant cards relate to eIFU?
MDR Article 18 requires implant cards for implantable devices to include the manufacturer website and UDI identifiers. Many teams link the implant card QR code or URL to a controlled eIFU portal, creating a seamless connection between the physical implant card and electronic instructions.
References
- MDR 2017/745 Article 18 (European Union) — 2017-04-05 — Article 18
Q5: Do I need EUDAMED to publish eIFU?
No, eIFU and EUDAMED are separate requirements. eIFU is for providing Instructions for Use electronically, while EUDAMED is for device registration and UDI data. However, some teams link UDI identifiers from EUDAMED to their eIFU portal for implant cards.
Q6: What is a validation pack (IQ/OQ/PQ) and why does a Notified Body care?
Validation typically includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Some vendors provide validation documentation packs, while others offer validation support services. Notified Bodies may request validation evidence during audits to ensure the eIFU system is properly qualified and maintained.
Provider Comparison Table
| Provider | Coverage | Key Features | Languages | Response SLA |
|---|---|---|---|---|
| Rimsys | Request quote | English | Request quote | |
| Reed Tech | Request quote | English | Request quote | |
| IFUcare (Qarad / QbD Group) | Request quote | English | 24h | |
| Meddevo eIFU | Request quote | English, German | Request quote | |
| DDi (Visu eIFU) | Request quote | English | Request quote | |
| eIFU.com (enLabel Global Services) | Request quote | Multilingual | 24h | |
| Innovatum (eLabeling / eIFU + ePIC) | Request quote | English | Request quote | |
| MEDELIA (RealBit) eIFU module | Request quote | English, German | Request quote | |
| Alysidia e-IFU Solutions | Request quote | English | Request quote | |
| MakroCare eIFU Services | Request quote | English | Request quote |
Sources & Official Guidance
Official sources vary by directory. See the applicable regulation and competent authority guidance for this role.
Last Updated: 2026-02-03
Reviewed by: Cruxi Regulatory Affairs Team
