CE Technical File: Your Passport to the European Market
A complete, audit-ready CE technical file is the foundation of every successful MDR submission. MEGACERT's regulatory experts build yours from scratch — or close the gaps in your existing documentation.
What is the CE Technical File?
Under EU MDR 2017/745, every medical device placed on the European market must be supported by a comprehensive Technical Documentation (TD). This structured body of evidence demonstrates that your device meets all applicable General Safety and Performance Requirements (GSPR) defined in Annex I of the MDR.
Unlike its predecessor under MDD 93/42/EEC, the MDR demands significantly deeper clinical justification, Post-Market Surveillance (PMS) integration, and a living documentation approach — meaning your technical file is never truly "finished."
MEGACERT has prepared technical files for Class I, IIa, IIb, and Class III devices across implantables, in vitro diagnostics, active devices, and non-active devices.
What Your CE Technical File Includes
Per MDR Annex II, MEGACERT prepares and reviews all mandatory sections:
| # | Section | What We Do |
|---|---|---|
| 1 | Device description & specification | Full device description, intended purpose, labelling, UDI structure |
| 2 | Design & manufacturing information | Materials, manufacturing process, supplier controls |
| 3 | GSPR checklist (Annex I) | Compliance matrix mapped to all applicable GSPRs |
| 4 | Benefit-risk analysis | Structured benefit-risk assessment per ISO 14971 |
| 5 | Product verification & validation | Test reports, standards harmonized under MDR |
| 6 | Post-Market Surveillance Plan | PMS Plan, PMCF Plan, PSUR/SSCP templates |
| 7 | Clinical evaluation report (CER) | MEDDEV 2.7.1 Rev. 4 / MDCG 2020-1 compliant CER |
| 8 | Instructions for Use (IFU) | MDR Annex I Chapter III compliant IFU review |
| 9 | Declaration of Conformity | Article 19 DoC drafted for signature |
Our 4-Step Technical File Process
- 01
Step 1 — Gap Analysis (Week 1)
We review your existing documentation (or start from zero) against MDR Annex II and your device's risk classification. You receive a written gap report with prioritized action items.
- 02
Step 2 — Documentation (Weeks 2–6)
Our regulatory writers draft each section of the Technical File. We align with harmonized standards applicable to your device (e.g., IEC 60601, ISO 10993, ISO 14971) and build a complete GSPR compliance matrix.
- 03
Step 3 — Expert Review (Week 7)
An independent senior auditor reviews the complete file — the same critical lens a Notified Body assessor would apply. All findings are closed before submission.
- 04
Step 4 — Submission Support (Week 8+)
We support your Notified Body submission, respond to queries (RFIs), and coordinate any required design or testing changes.
Frequently Asked Questions
Ready to build a CE Technical File that passes Notified Body scrutiny? Contact MEGACERT for a free, no-obligation gap analysis.
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