CE marking for medical devices — questions and answers

CE marking indicates that the manufacturer has declared the device compliant with all applicable EU legislation, including the MDR for medical devices or the IVDR for in vitro diagnostic devices. It is not a quality award or an approval issued by the European Commission.

Before affixing the mark, the manufacturer defines the intended purpose and device class, selects the conformity-assessment procedure, compiles the technical documentation and evidence, implements the required QMS processes and draws up the EU declaration of conformity. When a Notified Body has participated, its four-digit identification number appears next to the CE mark.

As a general rule, no. A device must complete the applicable conformity assessment and bear CE marking before it is placed on the market or put into service. Exceptions include custom-made and investigational devices, but those devices are subject to their own specific requirements.

Importers and distributors must verify the CE mark and declaration of conformity, together with other applicable information. A device lacking a required mark must not continue through the supply chain. A competent authority may require compliance to be restored, restrict or prohibit availability, or order withdrawal or recall. Penalties are determined by the national law of the relevant Member State.

No. The MDR distinguishes a non-compliant device from a falsified device. Absence of mandatory CE marking is a non-conformity, but it does not by itself establish falsification.

A falsified device falsely presents its identity, source, CE-marking certificates or documents relating to CE-marking procedures. The definition expressly excludes unintentional non-compliance. Deliberate use of a forged certificate or false CE documentation may, however, fall within the definition of a falsified device.

The consequences depend on the nature of the deficiency and the risk. A manufacturer may receive a deadline to correct a formal non-compliance. If a device presents an unacceptable risk, or corrective action is not completed, the competent authority may restrict or prohibit availability or require withdrawal or recall.

This can happen to a device of any class. A Notified Body certificate reduces the chance of missing a problem before market access, but it does not transfer the manufacturer’s responsibility or guarantee that later changes, production deviations, new safety information or inadequate post-market surveillance cannot create non-conformities.

No. The manufacturer affixes CE marking after completing the applicable conformity-assessment procedure and drawing up the EU declaration of conformity. There is no universal “CE certificate” issued for every medical device.

Class IIa, IIb and III devices, as well as Class Is, Im and Ir devices, require Notified Body involvement. The body issues a certificate within the scope of the selected procedure and its designation. A conventional Class I device is normally self-declared and receives no Notified Body certificate.

No. An FDA clearance, registration in another jurisdiction or UKCA marking does not replace MDR conformity and CE marking for the EU market. Tests and data prepared for another jurisdiction may sometimes support the evidence package when they are relevant to the MDR requirements and the particular device.

The manufacturer must still establish the European classification, demonstrate the GSPRs, prepare MDR technical documentation, perform a clinical evaluation, organise PMS, meet economic-operator, UDI and registration requirements and complete the applicable European conformity-assessment route.

Yes. Self-declaration means that no Notified Body performs a pre-market assessment; it does not remove MDR obligations. The manufacturer must demonstrate the applicable GSPRs, maintain Annex II and III technical documentation, perform risk management and clinical evaluation, operate a proportionate QMS, organise PMS and vigilance, appoint a PRRC and meet UDI, registration and declaration-of-conformity requirements.

Self-assessment is available for Class I devices that are not supplied sterile, have no measuring function and are not reusable surgical instruments. For Classes Is, Im and Ir, a Notified Body assesses the relevant special aspects.

A Notified Body is required for Classes IIa, IIb and III. For a Class I device it is required only for aspects connected with sterile condition, a measuring function or reuse of a surgical instrument. Classes Is, Im and Ir therefore undergo a limited third-party assessment.

The body must not be selected merely because it has a NANDO number. Its designation scope must cover the MDR, the relevant device codes and the applicable procedure. The manufacturer should confirm the designation scope and the body’s willingness to accept the project before applying.

There is no single European authority that approves a registration dossier for every device. For a conventional Class I device, the manufacturer does not submit technical documentation for pre-market approval. It keeps the file current and makes it available to competent authorities on request.

When a Notified Body is required, the manufacturer applies to that body under the selected conformity-assessment procedure. The depth of technical-documentation review depends on the class and route. Registration of the economic operator and device in EUDAMED is a separate obligation and does not replace conformity assessment.

No. ISO 13485 helps an organisation build a medical-device QMS, but certification to the standard does not by itself demonstrate that a particular device complies with the MDR. It does not replace classification, technical documentation, GSPRs, risk management, clinical evaluation, PMS, the declaration of conformity or Notified Body assessment.

Conversely, a separate ISO 13485 certificate is not always an independent legal prerequisite. What matters is that the QMS meets the applicable requirements of Article 10 MDR and the selected conformity-assessment procedure. A Notified Body assesses conformity with the MDR.

Yes. If a manufacturer is not established in an EU Member State, its device may be placed on the Union market only after it has designated a sole authorised representative in the EU under a written mandate. The representative must be appointed before the device is placed on the market.

The authorised representative verifies specified documents and registrations, keeps copies available, cooperates with authorities and performs the other tasks in the mandate. It does not design the device on behalf of the manufacturer or assume the manufacturer’s general responsibility for conformity.

The first four functional EUDAMED modules became mandatory on 28 May 2026. They cover actor registration, UDI and device registration, Notified Bodies and certificates, and market surveillance. For a manufacturer, the most immediate obligations are actor registration and obtaining an SRN, together with UDI and device registration before market placement when applicable.

EUDAMED registration is not a market authorisation. Before registration, the manufacturer needs a correct regulatory device structure, Basic UDI-DI, UDI-DI data, economic-operator details and a completed applicable conformity-assessment procedure.

There is no fixed period. A mature, non-sterile Class I device with completed tests and evidence may have a relatively short route. A device requiring new testing, a clinical investigation, a new QMS and Notified Body assessment can take substantially longer than a year.

The strongest time drivers are clarity of the intended purpose and classification, testing and clinical-evidence gaps, QMS readiness, supply-chain complexity, documentation quality and availability of a suitable Notified Body. A realistic schedule starts with a gap assessment rather than the device class alone.

Documentation may be proportionate to the device and its risks, but it cannot be fictitious or disconnected from actual processes. Annexes II and III define the technical-documentation structure, while the necessary testing and evidence depend on intended purpose, design, class, risks, manufacturer claims and applicable requirements.

A reviewer must be able to follow an uninterrupted chain from the intended purpose and claims to risks, requirements, verification and validation, clinical conclusions, labelling and PMS. If documents contradict one another or do not reflect actual development and production, adding templates does not restore conformity.

The scope of the QMS and certification can be limited to defined devices, processes and sites when its boundaries are clear. Functions that actually affect device conformity cannot be excluded. These include management, design, purchasing, suppliers, production, release, complaints, vigilance, PMS and change control.

Shared corporate processes and outsourced processes must be controlled to the extent that they affect the device. Creating a formal “regulatory division” does not solve the problem if relevant decisions are made or records are produced outside it.

Clinical evaluation is always required, but the manufacturer’s own clinical investigation is not mandatory for every device. The manufacturer must determine whether the available clinical data are sufficient to demonstrate safety, clinical performance and an acceptable benefit–risk ratio for the particular intended purpose.

Clinical investigations are the general rule for implantable and Class III devices, although Article 61 provides limited exceptions. An investigation may also be required for other classes when literature, equivalent-device data, experience data and other sources do not resolve material clinical questions. MDR equivalence requires technical, biological and clinical comparability together with sufficient access to the relevant data.

Information supplied with the device must be provided in the official Union language or languages required by the Member State where the device is made available to the user or patient. An English-only version therefore does not automatically support market access in every EU country.

The manufacturer should determine the language requirements of each target market and control translation, review, approval and updating of every version. An importer or distributor translating information under Article 16 assumes additional duties and, in specified circumstances, must notify the manufacturer and competent authority.

No. CE marking is not affixed to a custom-made device. This does not mean that the device is unregulated. The manufacturer must establish that the product genuinely meets the custom-made-device definition, comply with the applicable GSPRs, prepare the Annex XIII statement and keep documentation that makes the design, manufacture and performance understandable.

PMS, vigilance and other applicable MDR obligations continue to apply. A Class III implantable custom-made device requires Notified Body involvement under one of the procedures specified in Article 52(8).

No. CE marking demonstrates conformity at a point in time, but the manufacturer must maintain conformity throughout the lifecycle. Technical documentation, risk management, clinical evaluation, PMS, PMCF where applicable, labelling and registration data must be updated as new information and changes arise.

For devices certified by a Notified Body under Annex IX, planned surveillance takes place at least once every 12 months. Unannounced audits are also possible. For self-declared Class I devices, absence of routine Notified Body audits does not remove market surveillance by competent authorities.

Yes, but the change must pass through documented change control. The manufacturer assesses its effect on intended purpose, classification, risks, GSPRs, clinical data, verification and validation, labelling, UDI, PMS and existing certificates.

A change that substantially affects the approved QMS, covered device range, design or intended purpose must be submitted to the Notified Body in advance under the applicable procedure. Not every change requires a new certificate, but every change requires a traceable rationale and the necessary evidence before implementation.

The manufacturer must immediately assess the risk and nature of the non-conformity, identify affected batches and markets and take proportionate corrective action. Measures may include correcting documentation or labelling, updating software, carrying out a field safety corrective action, withdrawing the device or recalling it.

When the device presents a serious risk, vigilance and authority-notification requirements apply. The manufacturer works with the authorised representative, importers, distributors, Notified Body and competent authorities as applicable. The decision and follow-up belong in CAPA, risk-management and PMS records.

Yes. Before placing a device on the market, an importer verifies CE marking, the declaration of conformity, manufacturer identification, designation of an authorised representative for a non-EU manufacturer, labelling, instructions, UDI and registration where applicable. A distributor performs the checks required by Article 14 before making the device available.

If an importer or distributor has reason to believe that the device is non-compliant, it must not continue its circulation until the issue is resolved and must inform the relevant actors. A serious risk or suspected falsification must also be reported to the competent authority.

Sometimes, but only when both the device and manufacturer meet every transitional condition. For eligible Class III devices and certain Class IIb implantable devices, the transition ends on 31 December 2027. For other Class IIb devices, Class IIa devices and specified Class I devices that newly require a Notified Body under the MDR, it ends on 31 December 2028.

The extension is not automatic. Conditions included a timely Notified Body application by 26 May 2024 and written agreement by 26 September 2024, an implemented QMS, no significant design or intended-purpose change and no unacceptable risk. A new device cannot use the old route merely because a similar device once had an MDD certificate.

An economic operator assumes manufacturer obligations if it markets a device under its own name or trade mark, changes the intended purpose or modifies a device already placed on the market in a way that may affect conformity. An exception can apply where the original manufacturer is identified on the label under an agreed arrangement and continues to bear the manufacturer obligations.

Translation of supplied information and changes to outer packaging needed for a national market do not always make the operator the manufacturer, but Article 16 imposes separate conditions for those activities, including a QMS, notifications and, in specified cases, Notified Body certification of that QMS.