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Technische Dokumentation

Die technische Dokumentation liefert den Nachweis, dass Ihr Medizinprodukt den Vorschriften der Europäischen Union entspricht und die Anforderungen für die CE-Kennzeichnung erfüllt. Für die Zulassung von Medizinprodukten in der EU ist die technische Dokumentation unerlässlich.

Allgemeiner Aufbau der technischen Dokumentation (MDR/IVDR)

1. Device description

  • Name, General Description, Basic UDI-DI
  • Intended use, claims, patients, users, conditions, contraindications, warnings
  • Operating principles & mode of action
  • Classification including rule justification, rationale for classification as a device
  • Description, configuration, variants, accessories, other devices and combinations
  • Key functional elements (parts/formulation / composition / functionality)
  • Raw materials (of key functional elements & of parts with indirect/direct body contact)
  • Technical Specifications (Features/dimensions / performance attributes in specs made available to user)
  • Previous generations & similar devices on markets

2. Information supplied

  • Labels
  • Instructions for Use

3. Design & manufacturing

  • Design Stages applied (Design Control)
  • Design & Manufacturing specifications
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • Final product testing / Quality Control Plan
  • Site identification (All sites, suppliers, subcontractors with design/manufacturing actitivies)

4. General safety and performance requirements

  • List of applied standards including Common Specifications
  • GSPR Checklist / Matrix
  • Manufacturing processes, process validations, adjuvants & continuous monitoring
  • GSPR link to verification/validation including precise identity of evidence documents for each harmonised standard and Common Specification

5. Risk management

  • Risk Management Plan
  • Risk Management Methods, e.g. Preliminary Hazard Analysis, D-FMEA, P-FMEA, FTA, HAZOP, HACCP
  • Risk Management Report, including benefit-risk analysis

6. Design verification & validation

  • Clinical / Performance Evaluation Plan
  • Clinical / Performance Evaluation Report
  • Usability (where applicable)
  • Performance and Safety Test Results
  • Physical, Chemical & Microbiological Characterisation
  • Biocompatibility (where applicable)
  • Stability & Shelf Life
  • Reprocessing
  • Electrical Safety (where applicable)
  • Software Verification & Validation (where applicable)
  • Information on test design, test protocols, data analysis methods, data summaries and test conclusions

7. Post-market surveillance (Annex III)

  • Post Market Clinical Follow Up (PMCF) Plan & Report
  • PMS Plan & Report
  • Periodic safety update report (PSUR)

How we can help

We will develop technical documentation that complies with MDR or IVDR for your product. If you already possess technical documentation, we will conduct a gap analysis and fill the gaps to ensure its compliance with the relevant regulation.

Having expertly prepared technical documentation enables smooth regulatory approvals and straightforward maintenance of CE marking.

Send us an email:

Or use the contact form below