Technical Documentation Under MDR: What It Is and Why Startups Get It Wrong
Technical documentation is the evidence file that proves your device meets MDR. Here is what Annex II requires and why most startups build it wrong.
Category
Technical Documentation & Labeling
43 in-depth guides in this cluster
MDR Annex II: The Structure of Technical Documentation Explained
MDR Annex II lists exactly what the technical documentation must contain, section by section. Here is the structure, the order, and the traps startups fall into.
MDR Annex III: Technical Documentation on Post-Market Surveillance
MDR Annex III is the technical documentation dedicated to post-market surveillance. Here is what it contains, how it relates to Annex II, and how startups build it.
How to Build Technical Documentation from Day One as a Startup
Building technical documentation from day one does not mean Annex II-ready from day one. Here is the phased approach that avoids paralysis without losing traceability.
The Device Description in Technical Documentation: What to Include Under MDR
The device description is the first section of your MDR technical file. Here is what must appear in it and how to write it once so it survives design changes.
Documenting Your Device's Intended Purpose: The Foundation of Your Technical File
Your documented intended purpose drives classification, clinical evaluation, and labeling. Here is how to write it in the technical file so it holds up.
Design and Manufacturing Information in Technical Documentation
Annex II Section 3 requires design and manufacturing information in the technical file. Here is what belongs in it and how to avoid over-documenting or under-documenting.
How to Document General Safety and Performance Requirements (Annex I Checklist)
The GSPR checklist maps every MDR Annex I requirement to the evidence in your technical file. Here is how to build one auditors will accept.
Benefit-Risk Analysis in Technical Documentation: How to Present It Under MDR
The benefit-risk analysis is one section of Annex II Section 5 and one of the most scrutinised. Here is how to structure and present it.
Verification and Validation Evidence in Technical Documentation
V&V evidence is what proves your device meets its specifications and intended purpose. Here is how to organize it in the technical file so auditors can follow the chain.
Pre-Clinical Testing Documentation: What to Include for Bench and Animal Studies
Pre-clinical test evidence supports the benefit-risk analysis under MDR. Here is what to document for bench tests and animal studies in your technical file.
Biocompatibility Documentation Under MDR: ISO 10993 Evidence Requirements
Biocompatibility evidence under MDR relies on the ISO 10993 series. Here is the evidence structure, decision pathway, and what auditors look for in the technical file.
Chemical Characterization in Technical Documentation: Material Safety Evidence
Chemical characterization under ISO 10993-18 supports biocompatibility conclusions. Here is what to document for MDR and when full extractables/leachables studies are needed.
Sterilization Validation Documentation Under MDR
Sterile devices under MDR require validated sterilization processes documented in the technical file. Here is the evidence structure that satisfies Annex I Section 11.
Shelf Life and Stability Testing Documentation for Medical Devices
Shelf life claims under MDR must be supported by stability testing evidence. Here is what to document for accelerated and real-time studies.
Transport and Storage Validation in Technical Documentation
Transport and storage validation evidence under MDR: what to test, what to document, and where it sits in the technical file.
Software Documentation in the Technical File: What MDR and IEC 62304 Require
MDR Annex II and EN 62304 together define what software documentation must appear in the technical file. Here is the complete document set.
How to Keep Technical Documentation Up to Date: The Lifecycle Approach
Technical documentation under MDR is a living file, not a one-shot submission. Here is the lifecycle approach that keeps it audit-ready year after year.
Technical Documentation Review by Notified Bodies: What Gets Scrutinized
When a Notified Body reviews technical documentation, they sample specific sections and trace evidence chains. Here is what they actually check.
Technical Documentation Templates for Startups: Where to Start
Templates can speed up MDR technical documentation work or sink it. Here is the right way to use them and how to avoid the Berlin template trap.
How to Manage Technical Documentation with a Small Team
Managing the MDR technical file with a 3-person team is possible if you pick the right structure, tools, and discipline. Here is the practical approach.
Document Control Under MDR: Version Control, Approval, and Distribution
Document control under MDR ties version, approval, and distribution into one auditable chain. Here is how to run it without overhead.
Technical Documentation for Class I Devices: The Minimum Viable Technical File
Class I devices still need a technical file under MDR Annex II. Here is the minimum viable version that satisfies self-certification requirements.
Technical Documentation for Software as a Medical Device: Special Considerations
SaMD technical documentation has special considerations under MDR Annex II. Here is what differs from physical-device tech files.
How to Cross-Reference Documents in Your Technical File Efficiently
Cross-reference your MDR technical file so evidence is traceable in minutes, not days. GSPR-driven matrix, naming conventions, tooling.
Common Technical Documentation Gaps Found in Startup Audits
The ten most common technical documentation gaps that surface in startup MDR audits — and the Annex II section each one lives in.
MDR Labeling Requirements: What Must Appear on Your Device Label
MDR Annex I Chapter III Section 23 lists what must appear on a medical device label. Here is the complete list with how it applies to small labels.
MDR Annex I Chapter III: Information Supplied with the Device
MDR Annex I Chapter III defines the information that must be supplied with every device. Here is the structure of Section 23 and what it requires.
The Instructions for Use (IFU) Under MDR: How to Write Compliant IFUs
The IFU must meet MDR Annex I Chapter III and survive usability engineering. Here is how to write one that auditors accept and users understand.
When an IFU Is Not Required Under MDR: Class I Exceptions
Some Class I devices can be placed on the market without paper IFU under MDR Annex I Chapter III. Here is when the exception applies and what still must be communicated.
Electronic Instructions for Use (eIFU) Under MDR: Going Digital
When you can replace a paper IFU with an eIFU under MDR and Regulation (EU) 2021/2226: eligible devices, website rules, and paper-on-request.
MDR Symbol Requirements: Using ISO 15223-1 Symbols on Labels
MDR allows symbols on labels only from a recognised standard. Here is how EN ISO 15223-1:2021 maps to Annex I Chapter III Section 23.
The UDI on Your Label: How to Display the Unique Device Identifier
MDR Article 27 requires the UDI to appear on the device label. Here is how to display UDI-DI and UDI-PI correctly.
Implant Cards Under MDR: Requirements for Implantable Device Manufacturers
MDR Article 18 requires manufacturers of implantable devices to provide an implant card. Here is what it must contain and how to design one.
Labeling in Multiple EU Languages: Practical Approaches for Startups
MDR Article 10(11) sets language for labels, IFU, and patient information per Member State. Here is a practical multi-language approach for startups.
Patient Information Under MDR: Writing for Lay Users
MDR Annex I Section 23 and Article 32 force patient information into plain language. Here is how to write lay-user content auditors and patients accept.
Promotional Material Compliance Under MDR Article 7
MDR Article 7 prohibits misleading promotional claims. Here is what promotional material can and cannot say about your medical device.
Misleading Claims Under MDR: How to Stay Compliant in Marketing
MDR Article 7 prohibits misleading claims. Your marketing must stay within the technical documentation and the intended purpose. Here is the compliance line.
Labeling for Software as a Medical Device: Digital Label Requirements
MDR labeling requirements apply to SaMD as much as to physical devices. Here is how to deliver MDR-compliant labels and IFU through a digital interface.
Lot Numbering and Traceability Requirements Under MDR
Lot numbering is the production identifier that makes MDR Article 25 traceability and recalls actually work. Here is the startup playbook.
CE Mark Placement and Formatting Requirements Under MDR
How to place, size, and format the CE mark on medical devices under MDR Article 20 and Annex V — with Notified Body number rules.
The 10 Most Common Labeling Mistakes Startups Make Under MDR
The ten most common labeling mistakes in MedTech startup audits — each with the Annex I Chapter III requirement it violates and the fix.
Technical Documentation and Labeling Checklist: The Complete Startup Audit Prep
The complete pre-audit checklist for MDR technical documentation and labeling: every Annex II section, every Annex I Chapter III label item, every cross-reference.