CE Marking – EU Conformity Mark for Medical Devices

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • EU Market Access & Conformity • QA, RA, Supply Chain, Manufacturing, IT

CE marking is the visible proof that a product placed on the European Economic Area (EEA) market meets applicable EU safety, health, and performance requirements. For medical devices and IVDs, CE marking means the manufacturer has completed the conformity assessment under the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), compiled technical documentation, implemented a compliant Quality Management System (QMS), and issued an EU Declaration of Conformity (DoC). The CE mark is not a marketing badge—it is a legal claim of conformity that regulators, notified bodies, and customers can challenge.

“When you print the CE mark on a label, you’re publicly stating: ‘this device meets all EU requirements and we can prove it’—today, not five years ago.”

1) What CE Marking Actually Means

For medical devices and many other regulated products, CE marking means that:

• The product falls under one or more EU harmonized legislative acts (e.g. MDR/IVDR, machinery, EMC, RoHS) and the manufacturer has identified all applicable requirements.
• A conformity assessment has been performed according to the relevant legal route (self-certification, notified body assessment, type examination, or full QMS assessment).
• The manufacturer has compiled and maintains up-to-date technical documentation and risk management files.
• An authorized individual has signed a valid EU Declaration of Conformity.
• For devices requiring Notified Body involvement, a current certificate is in force and the CE mark is accompanied by the Notified Body identification number.

CE marking is therefore a system-level claim about design, manufacturing, and post-market control—not just a label design choice.

2) Legal Basis – MDR, IVDR & Other Directives

Within healthcare, CE marking is governed primarily by:

• MDR (EU) 2017/745: general medical devices, implantables, active devices, software as a medical device (SaMD), etc.
• IVDR (EU) 2017/746: in vitro diagnostic medical devices.

Devices may also need to meet other EU legislation (e.g. RoHS, EMC, Radio Equipment Directive, machinery) depending on technology and intended use. The manufacturer must identify and comply with all applicable acts and standards when affixing the CE mark.

Outside medical devices, CE marking is used across multiple product categories, but the basic idea is the same: one mark, backed by full technical and regulatory evidence for the relevant directives/regulations.

3) Which Products Require CE Marking?

CE marking is required when all three are true:

• The product is covered by EU legislation that mandates CE marking (e.g. MDR/IVDR).
• The product is placed on the EU/EEA market (or otherwise made available—sale, loan, lease, or free of charge).
• The product is not exempted by a specific provision (e.g. custom-made devices with special rules, investigational devices under clinical investigation frameworks).

In practice, most commercially distributed medical devices and IVDs in the EU/EEA must carry a CE mark to be legally sold, imported, or put into service, with narrow exceptions.

4) Core Elements of CE Marking for Medical Devices

From a manufacturer’s standpoint, CE marking requires a tightly linked set of elements:

• Intended purpose & classification: clear intended use and risk-based classification under MDR/IVDR.
• QMS: implementation of a compliant ISO 13485-based QMS covering design, production, and post-market control.
• Risk management: device-level risk files aligned with QRM/ISO 14971, linked to design and process controls.
• Clinical evaluation / performance evaluation: clinical data (MDR) or performance/clinical evidence (IVDR) supporting safety and performance claims.
• Technical documentation: design, manufacturing, verification/validation, labeling, usability, cybersecurity, and more.
• PMS / vigilance: post-market surveillance, vigilance, and trend reporting.

All of these are sampled and challenged during audits and inspections; weak links are where CE claims fall apart.

5) The CE Marking Process – High-Level Steps

Although details vary by device class and route, the CE marking process typically follows:

• 1) Determine intended use and classification. Define indications, users, environment, and risk class under MDR/IVDR.
• 2) Identify applicable requirements. List all relevant EU regulations/directives, harmonized standards, and guidance.
• 3) Implement and operate the QMS. Build an ISO 13485-aligned QMS covering design, production, and post-market activities.
• 4) Generate technical documentation. Create and maintain the technical file (design, risk, verification/validation, labeling, UDI, etc.).
• 5) Conformity assessment. For many devices, this includes notified body QMS and/or technical documentation assessment.
• 6) Issue the Declaration of Conformity. Once all conditions are met, sign and date the DoC.
• 7) Affix the CE mark. Place the CE symbol (and NB number where required) on the device, packaging, and IFU.
• 8) Maintain CE compliance. Run PMS, vigilance, and periodic reviews; update documentation and DoC as needed.

Rushing steps 3–7 is how companies end up in recall and suspension territory when regulators or notified bodies take a closer look.

6) Technical Documentation & Traceability

To genuinely support CE marking, technical documentation must be complete, structured, and maintained. Typical contents include:

• Device description, variants, and intended purpose.
• Design and manufacturing information, including drawings and specifications.
• Risk management files linked to control measures in design and manufacturing.
• Verification and validation data (bench, software, usability, packaging, sterilization, shelf-life, etc.).
• Clinical evaluation or performance evaluation reports.
• Labeling, IFU/eIFU, and translations.
• UDI strategy and traceability model, including eDHR / eBR linkages.

The CE mark relies on this documentation being current and aligned with real-world devices, not just with the “ideal” version from three revisions ago.

7) Notified Bodies & CE Marking

For many medium- and high-risk devices, a Notified Body must review your QMS and technical documentation before CE marking. Key expectations:

• Notified bodies review design, risk management, clinical/performance evidence, and QMS effectiveness.
• They issue certificates (QMS and/or product) that underpin CE marking for defined scope and device types.
• Their identification number appears next to the CE mark on the device and packaging.
• They conduct periodic surveillance and re-certification audits; serious issues can result in suspension or withdrawal.

Notified bodies are independent but regulated themselves; they are under pressure from authorities to challenge weak evidence, not simply renew certificates on autopilot.

8) Economic Operators & Responsibilities

Under MDR/IVDR, CE marking obligations are distributed across economic operators:

• Manufacturer: designs, manufactures, labels, maintains documentation, issues the DoC, and affixes the CE mark.
• Authorized Representative (AR): mandatory for non-EU manufacturers; holds technical documentation and acts as contact point for authorities.
• Importer: verifies CE marking, labeling, and DoC; ensures their name and address appear on the device.
• Distributor: checks that devices bear CE marking and are accompanied by required information before making them available.

CE marking is therefore a shared responsibility; when authorities investigate, they will look at how all economic operators fulfill their obligations, not only the manufacturer.

9) PMS, Vigilance & Maintaining CE Compliance

CE marking is not a one-time event. To maintain it over the device lifecycle, manufacturers must:

• Run a documented Post-Market Surveillance (PMS) system, including proactive data collection and reactive complaint handling.
• Meet vigilance reporting obligations (serious incidents, field safety corrective actions) within defined timelines.
• Analyze trends, update risk files, technical documentation, and labeling where needed.
• Feed PMS outcomes into CAPA and Management Review.

Ignoring PMS and vigilance turns the CE mark into a snapshot from product launch; regulators expect it to reflect current, evidence-based understanding of device performance and risk.

10) UDI, EUDAMED & Digital Traceability

Modern CE marking is increasingly tied to digital traceability:

• UDI: Unique Device Identification must be assigned and applied to labels, packaging, and in some cases the device itself.
• EUDAMED: Device registration, certificates, vigilance, and market surveillance data are being centralized at EU level.
• Internal traceability: Manufacturers must connect UDI and batch/serial data to eDHR / eBR systems to support recalls, vigilance, and field actions.

Without robust MES/WMS/QMS integration, maintaining accurate UDI and EUDAMED data becomes a manual, error-prone task that auditors and authorities can quickly expose.

11) Misuse of CE Marking & Common Pitfalls

• Affixing CE without full scope coverage: device meets some, but not all, applicable EU legislation.
• Expired or withdrawn NB certificates: CE mark remains on product while underlying certificate is no longer valid.
• Outdated technical documentation: design or process changes implemented without updating risk files and validation.
• “CE-like” marks: using misleading logos or graphics that resemble CE but are not legally valid.
• No linkage to PMS: CE marking not updated when post-market data reveals new risks or performance issues.

All of these place patients at risk and expose the manufacturer—and distributors/importers—to significant regulatory and commercial consequences.

12) How CE Marking Connects to V5 by SG Systems Global

Execution evidence for CE, not just documents. The V5 platform supports CE marking by generating and maintaining real-time production, quality, and traceability records that underpin your technical documentation and PMS obligations.

Device history and UDI traceability. V5 captures material lots, serials, UDI, operator IDs, parameters, and in-process checks into structured eDHR and eBR records. That supports CE marking requirements for traceability, recall readiness, and alignment with UDI/EUDAMED data.

Risk, CAPA, and PMS workflow. Deviations, complaints, and nonconforming product captured in V5 can escalate to CAPA, risk assessments, and label or IFU changes. This provides an auditable link between PMS outcomes and CE marking decisions.

QMS and document control. Procedures, work instructions, and forms that underpin CE marking live under Document Control in V5, with effective dating, e-signatures, and training verification so operators cannot execute obsolete methods on the shop floor.

Inspection-ready datasets for MDR/IVDR and Notified Bodies. During CE-related audits or inspections, V5 can provide read-only snapshots of eDHR, production logs, audit trails, and CAPA histories, so you demonstrate conformity with MDR/IVDR requirements using live operational data, not manual reconstructions.

Bottom line: CE marking is only as strong as the evidence behind it; V5 helps device manufacturers generate, connect, and defend that evidence day-to-day across production, quality, and supply chain.

13) FAQ

Q1. Is CE marking the same as FDA approval?
No. CE marking is an EU/EEA conformity mark based on MDR/IVDR and other EU legislation. FDA clearance or approval is a separate US regulatory process. Many global manufacturers need both, but they are not interchangeable.

Q2. Do all medical devices need CE marking to be sold in the EU?
In general, yes—commercial medical devices and IVDs placed on the EU/EEA market must carry a CE mark under MDR/IVDR, with narrow exceptions (e.g. certain custom-made or investigational devices under specific conditions).

Q3. Who is responsible for CE marking?
The manufacturer is primarily responsible for CE marking, including technical documentation, risk management, and the Declaration of Conformity. Authorized representatives, importers, and distributors also have defined obligations to verify and support CE claims.

Q4. Does CE marking automatically cover software and cybersecurity?
It must. For software and connected devices, CE marking implies that cybersecurity, software lifecycle, and data protection risks have been addressed in design, validation, and PMS in line with MDR/IVDR and applicable standards.

Q5. How often must CE marking be updated?
There is no fixed calendar date, but CE marking must remain valid. That means updating technical documentation, risk files, labeling, and the DoC when significant changes occur (e.g. design, software, materials, indications, standards, or PMS findings) and ensuring underlying certificates remain current.

Q6. Can we put the CE mark on a device before all tests and reviews are complete?
No. Affixing the CE mark before completing the conformity assessment, technical documentation, and Declaration of Conformity is a regulatory breach. The mark may only be applied once all applicable requirements are satisfied and documented.

Related Reading
• Core Regulatory: ISO 13485 Requirements | Quality Management System (QMS) | Notified Body | Declaration of Conformity (DoC)
• Device Records & UDI: eDHR Software | Device History Record (DHR) | Electronic Batch Record (eBR) | Unique Device Identification (UDI)
• Risk & PMS: Risk Management (QRM) | Post-Market Surveillance (PMS) | CAPA
• Digital Execution: MES | WMS