Technical Documentation for CE Marking: What You Need & How to Build It

What Is Technical Documentation?

Technical documentation (also called a technical file) is the complete package of documents that demonstrates how your product meets the essential requirements — or general safety and performance requirements — of the applicable EU directive or regulation.

It is a legal requirement, not optional. The manufacturer must compile and maintain it before affixing the CE mark. For products requiring Notified Body assessment, the NB reviews the technical documentation as part of its conformity assessment. For self-declaration products, market surveillance authorities can request the technical file at any time.

The technical documentation must remain available for 10 years after the last product is placed on the market (15 years for implantable medical devices under MDR).

Technical Documentation Under MDR (Annexes II and III)

MDR 2017/745 defines the most detailed and prescriptive technical documentation requirements of any EU product regulation. Annex II covers the main technical documentation; Annex III covers post-market surveillance technical documentation.

Technical Documentation for Non-Medical CE Products

For products outside MDR/IVDR — such as machinery, electronics, PPE, or construction products — the technical documentation requirements follow the applicable directive. While less prescriptive than MDR, they cover the same core elements:

The GSPR Checklist for Medical Devices

One of the most important documents in an MDR technical file is the General Safety and Performance Requirements (GSPR) checklist. This document maps each requirement from MDR Annex I against your product and documents how compliance is demonstrated — typically through reference to harmonised standards, test reports, risk management outputs, or other evidence.

A well-structured GSPR checklist:

• Lists all applicable GSPR items (and justifies exclusion of non-applicable ones)
• References the specific harmonised standard(s) applied for each requirement
• Cross-references to the relevant section of the technical file where evidence is found
• Includes revision history as standards and requirements change

Risk Management — The Core of Any Technical File

Risk management documentation is central to technical files across all product categories. For medical devices, ISO 14971 is the internationally harmonised standard for medical device risk management. For machinery, EN ISO 12100 covers risk assessment and risk reduction.

A complete risk management file includes:

• Risk management plan — scope, responsibilities, criteria for acceptable risk
• Hazard identification — systematic identification of all foreseeable hazards
• Risk analysis — probability and severity estimation for each hazard
• Risk evaluation — comparison against acceptability criteria
• Risk control measures — design, protective measures, information for safety
• Residual risk evaluation — confirmation that residual risks are acceptable
• Overall residual risk assessment — benefit-risk conclusion
• Risk management review — ongoing updates based on post-market data

Clinical Evaluation for Medical Devices (MDR)

Under MDR, the Clinical Evaluation Report (CER) is one of the most demanding elements of the technical documentation. It must demonstrate that the device achieves its intended purpose and that the benefit-risk balance is acceptable based on clinical data — not just preclinical testing.

Clinical data sources for the CER include:

• Clinical investigations of the device
• Clinical investigations of equivalent devices (with strict equivalence criteria)
• Published scientific literature on the device or equivalent devices
• Post-market clinical follow-up data

Common Technical Documentation Mistakes

• Treating the technical file as a one-time exercise — it must be a living document, updated with post-market data, standard updates, and design changes
• Missing or incomplete GSPR mapping — simply listing standards without demonstrating how each GSPR is addressed
• Outdated harmonised standards referenced — withdrawn standards no longer provide presumption of conformity
• Insufficient clinical data — particularly for MDR, where clinical evaluation requirements are significantly higher than under MDD
• Risk management not connected to the rest of the file — risk controls must be traceable through design verification and testing
• No document control — technical files submitted to a Notified Body must have version control; uncontrolled documents are a common non-conformity finding
• IFU not translated — instructions for use must be available in the languages of all target markets

Maintaining Technical Documentation After CE Marking

CE marking is not a one-time event. Technical documentation must be maintained and updated throughout the product's lifecycle:

• Update risk management file with post-market data and field experience
• Monitor changes to harmonised standards and update compliance documentation
• Review and update the CER/clinical evaluation periodically (at least annually for Class III MDR devices)
• Document all design changes and assess their regulatory impact (significant change may require NB notification or re-assessment)
• Maintain PMS records and update PSUR as required

Frequently Asked Questions