Educational MDR compliance training tool
This free educational tool helps you understand the two distinct compliance tracks required by Regulation (EU) 2017/745. Walk through guided questions to learn which company-level quality system documents and which product-level technical file documents apply to different roles, device types, and risk classes. Explore 87 template structures adapted from the open-source OpenRegulatory library, fill in practice drafts, and export them for study purposes.
This tool is for learning and orientation only. It does not provide regulatory, legal, or quality management advice. All outputs are practice drafts that require professional review before any regulated use. See the full disclaimer.
Learn track one
Understand the company-wide obligations: legal manufacturer role, quality management system, document control, training, supplier qualification, CAPA, internal audit, management review, complaint handling, vigilance, and post-market surveillance procedures.
Learn track two
Explore the per-device documentation: intended use, MDR classification, GSPR checklist, risk management, clinical evaluation, software lifecycle, usability engineering, and post-market clinical follow-up, each tailored to device type and risk class.
Practice and export
Each template opens as a structured form matching the upstream OpenRegulatory section layout. Fill in practice content to learn the document structure, then export drafts as DOCX or PDF for offline study.
87 templates
Answer intake questions about your company role, device type, risk class, and lifecycle stage. The tool recommends which of the 44 company and 43 product templates are relevant, so you learn which documents apply and why.
Learning path: company
Learning path: product
References
The template catalog is mapped from the local clone of the public OpenRegulatory templates repository.
This first pass is optimized for MDR manufacturers and product teams. It also gives guidance to representatives and importers, but the strongest template depth is on the manufacturer route.
Exported files are structured drafting outputs. They still require review, tailoring, approval, and controlled release before regulated use.
Legal notice
This website and all content, templates, forms, and generated outputs are provided solely for educational and informational purposes. Nothing on this website constitutes legal, regulatory, or professional compliance advice. You should not rely on this website as a substitute for consultation with qualified regulatory, legal, or quality management professionals.
All content is provided "as is" and "as available" without warranties of any kind, whether express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, completeness, or non-infringement. The authors make no guarantees that the information is current, correct, or complete, or that use of this website will satisfy any regulatory requirement.
In no event shall the authors, contributors, or licensors be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising out of or related to your use of or inability to use this website, including but not limited to regulatory non-compliance, failed audits, rejected submissions, product recalls, or any other commercial or legal consequences.
This website does not constitute a quality management system, does not meet the requirements of ISO 13485, EU MDR 2017/745, or any other regulatory standard, and must not be used as a controlled document system. All outputs require independent review, validation, approval, and controlled release within a compliant QMS before any regulated use.
Template content is adapted from OpenRegulatory Templates under CC BY-NC-SA 4.0. References to EU regulations, ISO standards, and IEC standards are for informational purposes only. This website is not affiliated with, endorsed by, or associated with any regulatory authority, notified body, or standards organization.
You are solely responsible for determining the suitability of any content, template, or output for your specific situation. Use of this website is entirely at your own risk. By using this website, you acknowledge and agree to this disclaimer in its entirety.