EU MDR Technical Documentation: Purpose and Contents

EU MDR technical documentation is the backbone of compliance for medical devices in Europe. It must comprehensively demonstrate conformity with EU medical device regulations and its documentation requirements. The MDR technical documentation must be prepared before placing a medical device in the EU market.

What is EU MDR technical documentation?

EU MDR technical documentation is the comprehensive set of records that medical device manufacturers must compile and maintain to demonstrate conformity with EU MDR. It covers the device’s description, intended purpose, design and manufacturing processes, risk management. Additionally, it demonstrates compliance with General Safety and Performance Requirements (GSPR). Moreover, it should include clinical evaluation, product verification and validation, labeling and instructions for use, and post‑market surveillance plans. It is mandatorily required before a device can be placed in the EU market. This technical documentation must be readily available to notified bodies and authorities to prove safety, performance, and regulatory compliance throughout the product’s lifecycle.

Notably, EU MDR technical documentation is far more rigorous than that under MDD. It requires structured evidence across design, risk, clinical, and post-market domains.

Purpose of the MDR technical documentation

The purpose of EU MDR technical documentation is to provide clear, structured evidence that a medical device complies with the requirements of EU MDR. It serves as the manufacturer’s proof of conformity demonstrating that the device is safe, performs as intended, and meets all applicable General Safety and Performance Requirements (GSPR). This documentation enables notified bodies and competent authorities to verify compliance during conformity assessments, audits, and inspections. Beyond initial approval, it also supports lifecycle obligations, such as risk management, clinical evaluation, and post‑market surveillance, thereby ensuring ongoing patient safety and regulatory accountability. Furthermore, the technical documentation is a critical requirement for the CE marking process.

General obligations

• The technical documentation must be prepared before placing a device on the EU market.
• The technical documentation must be available to market surveillance authorities upon request.
• The documentation should preferably be in English or an official language of an EU Member State.
• The manufacturer or their appointed authorized representative must retain the documentation for at least 15 years from the product’s last date of manufacture. Moreover, non-EU manufacturers must place the file with their authorized representative in the EU.

What are the contents of the EU MDR technical documentation?

EU MDR technical documentation is divided into two components pre‑market requirements and post‑market surveillance. It ensures that every device’s design, safety, performance, and lifecycle monitoring are fully documented. Together, they provide the evidence regulators need to assess conformity and ongoing compliance.

Pre‑market technical documentation

This section is the foundation of the dossier, covering how the device is designed, manufactured, and validated before market entry.

• Device description and specifications: This section should include intended purpose, classification, variants, accessories, Unique Device Identification (UDI) information, raw materials, components, and technical drawings.
• Information supplied by manufacturer: Labels, packaging, Instructions for Use (IFU), marketing and promotional material have to be included.
• Design and manufacturing information: This section should include description of manufacturing processes, quality control procedures, and supplier details.
• General Safety and Performance Requirements (GSPR) checklist: Evidence of conformity with MDR Annex I requirements has to be provided. Additionally, cross‑references to standards (ISO 13485, ISO 14971, IEC 60601, etc.) have to be provided.
• Risk management documentation: This section should include ISO 14971‑compliant risk analysis, benefit‑risk determination, and mitigation strategies.
• Product verification and validation: This section should include biocompatibility, sterilization validation, shelf‑life studies, and software validation (if applicable). Electrical safety, mechanical testing, and usability studies also have to be included.
• Clinical evaluation: A Clinical Evaluation Report (CER) will be required. Literature review, clinical data, and equivalence justification have to be included.

Post‑market surveillance (PMS) documentation

This section ensures the device remains safe and effective once sold.

• Post‑market surveillance (PMS) plan: Strategy for collecting and analyzing post‑market data have to be included. Additionally, feedback loops have to be included in risk management and CAPA systems.
• Periodic safety update report (PSUR): A PSUR is required for Class IIa, IIb, and III medical devices. Summarize post‑market findings, corrective actions, and benefit‑risk reassessment in this report.
• Vigilance and trend reporting: Procedures for adverse event reporting have to be included in this section. Trend analysis of non‑serious incidents will be required.
• Post‑market clinical follow‑up (PMCF): Ongoing clinical data collection to confirm long‑term safety and performance is necessary.

Who reviews the EU MDR technical documentation?

The EU MDR technical documentation is primarily reviewed by Notified Bodies (NBs) and, in some cases, by Competent Authorities (CAs) in EU member states:

• Notified bodies (NBs): For medium‑ and high‑risk devices (Class IIa, IIb, III), NBs conduct conformity assessments. On the other hand, for lower‑risk devices (Class I), there is no notified body involvement and manufacturers must self‑declare conformity. NBs review the technical documentation to verify compliance with MDR Annex II and III requirements. Their role includes checking risk management, clinical evaluation, PMS plans, and ensuring the General Safety and Performance Requirements (GSPR) are met.
• Competent authorities (CAs): National regulatory agencies (e.g., BfArM in Germany, ANSM in France) may request and review documentation. They oversee market surveillance, investigate complaints, and ensure manufacturers maintain documentation for the required period. For lower‑risk devices (Class I), manufacturers self‑declare conformity but CAs can audit or inspect documentation at any time.

Why is technical documentation important?

Technical documentation under the EU MDR is important because it acts as the manufacturer’s formal proof that a medical device is safe, performs as intended, and complies with all regulatory requirements. It provides a structured record of the device’s design, risk management, clinical evaluation, and post‑market surveillance. The documentation ensures transparency and traceability across the entire product lifecycle. Regulators, notified bodies, and competent authorities rely on this documentation to verify conformity during audits, inspections, and market surveillance. Beyond regulatory approval, it also protects patients by enabling continuous monitoring of device performance, supports manufacturers in defending product safety, and ensures readiness for global submissions or investigations.

5 common challenges faced while preparing EU MDR technical documentation

1. Expanded scope under MDR: Devices previously outside regulation (e.g., certain software,) now require full documentation. Hence, manufacturers are struggling to meet the new requirements for technical documentation.
2. Clinical evidence burden: MDR demands stronger, more robust clinical data, especially for Class III and implantables.
3. Complex risk management integration: ISO 14971 risk files must be fully aligned with design, manufacturing, and PMS documentation. Many manufacturers find it difficult to maintain consistency across risk analysis, CAPA, and vigilance records.
4. Post‑market surveillance (PMS) & PSUR requirements: Annex III introduces the need for structured PMS plans and periodic safety update reports in the technical documentation file. Smaller manufacturers often lack systems to collect and analyze post‑market data effectively.
5. Audit readiness and documentation consistency: Notified bodies expect cross‑referenced, gap‑free dossiers. Inconsistent formatting, missing GSPR checklists, or poorly linked validation reports can trigger non‑conformities.

Contact us for hassle-free EU MDR technical document preparation.

Therefore, EU MDR technical documentation plays a pivotal role in demonstrating a medical device’s safety, performance, and compliance throughout its lifecycle. By providing information across design, risk management, clinical evaluation, and post‑market surveillance, it ensures transparency for regulators, accountability for manufacturers, and protection for patients. This documentation is necessary for securing the CE marking and EU market access. Furthermore, it strengthens audit readiness, supports global submissions, and builds long‑term trust in the device’s reliability and the manufacturer’s quality system. For any assistance with MDR technical documentation preparation, email at [email protected] or call/Whatsapp on 9996859227. Our team will prepare and compile the technical documentation as EU MDR requirements.