CE marking indicates that the manufacturer has assessed a product against the applicable EU requirements that require CE marking. For medical devices placed on the EU market, the route to CE marking depends on the device, its classification and the applicable conformity assessment procedure.
For medical device manufacturers, CE marking is not a certificate issued by a central EU authority. The manufacturer is responsible for identifying the applicable requirements, compiling the required technical documentation, completing the appropriate conformity assessment and drawing up the EU Declaration of Conformity before affixing the CE mark. Where legislation requires third-party assessment, an appropriately designated notified body must be involved.
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What does CE marking mean?
By affixing CE marking, a manufacturer declares that the product meets the applicable EU legal requirements for CE marking. CE marking applies only to products covered by EU rules that require it; it must not be used where those rules do not apply.
For medical devices, the relevant EU framework includes Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as applicable.
Who is responsible for CE marking?
The manufacturer is responsible for ensuring that the product meets the applicable EU requirements and for affixing the CE marking. A business is considered the manufacturer if it makes a product itself, or has it made and markets it under its own name or brand.
Importers, distributors and authorised representatives also have defined responsibilities under applicable legislation, but these do not remove the manufacturer’s responsibility for product conformity.
How to obtain CE marking for a medical device
There is no central EU body that issues permission to use the CE mark. The route depends on the applicable legislation and conformity assessment procedure.
Confirm that CE marking applies
Identify the EU legislation that applies to the product and confirm that CE marking is required.
Determine the device classification
For medical devices and IVDs, classification affects the applicable conformity assessment route and whether third-party involvement is required.
Identify the applicable requirements
Determine the relevant general safety and performance requirements and other obligations that apply to the device.
Establish technical documentation
Compile the technical documentation needed to demonstrate conformity.
Complete the conformity assessment
Follow the conformity assessment procedure required by the applicable legislation. Where self-assessment is permitted, a notified body is not required.
Draw up the EU Declaration of Conformity
The manufacturer must draw up and sign the EU Declaration of Conformity once the applicable requirements have been met.
Affix the CE marking
Once the required conformity assessment is complete, the CE marking can be affixed in accordance with the applicable rules.
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Manufacturing input can help align the design, tooling and production process with the evidence required for the device.
When is a notified body required?
Whether a notified body is required depends on the applicable legislation and conformity assessment procedure. Manufacturers need to check whether self-assessment is permitted or third-party assessment is required.
The European Commission’s NANDO database identifies notified bodies and the activities for which they are designated. Where a notified body is involved, its four-digit identification number must appear next to the CE marking, as required by the applicable rules.
Can medical devices be self-certified for CE marking?
Some devices can follow a self-declaration route, but this depends on classification and applicable EU legislation. Manufacturers should confirm the route for their individual device rather than assuming all Class I devices can be self-certified.
Technical documentation for CE marking
Technical documentation provides evidence used to demonstrate that a medical device meets applicable requirements. It can include information on intended purpose, classification, design and manufacture, risk management, verification and validation, clinical evidence, labelling and post-market activities.
Europlaz manufacturing services that may support technical documentation include design for manufacture, medical injection moulding, cleanroom assembly and medical device validation.
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Risk management and CE marking for medical devices
Risk management is an important part of demonstrating that a medical device meets applicable safety and performance requirements. Manufacturing considerations can affect the evidence supporting conformity, including validation, inspection, testing, controlled documentation, assembly, packaging and sterilisation.
What is the EU Declaration of Conformity?
The EU Declaration of Conformity is the manufacturer’s declaration that the product meets applicable EU requirements. It is drawn up and signed after the required conformity assessment has been completed.
The declaration and supporting technical documentation must be kept up to date and retained for the applicable period.
How should the CE mark be displayed?
CE marking must be visible, legible and indelible. Unless product-specific rules provide otherwise, the CE letters have a minimum vertical dimension of 5 mm and their proportions must be preserved when resized.
How should the CE mark be displayed?
CE marking must be visible, legible and indelible. Unless product-specific rules provide otherwise, the CE letters have a minimum vertical dimension of 5 mm and their proportions must be preserved when resized.
Is CE marking the same as product approval?
No. CE marking does not mean that a product has been approved as safe by the EU or another authority. It is the manufacturer’s declaration that the product meets applicable requirements following the required conformity assessment.
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Europlaz supports IQ, OQ and PQ activities where applicable to the agreed manufacturing process.
Is CE marking still valid in the UK?
The position differs between Great Britain and Northern Ireland.
Great Britain
Current transitional arrangements permit qualifying CE-marked medical devices to be placed on the Great Britain market. MDD/AIMDD devices are accepted until the sooner of certificate expiry or 30 June 2028; IVDD devices until the sooner of certificate expiry or 30 June 2030; and MDR/IVDR devices until 30 June 2030. Applicable MHRA registration requirements also apply.
Northern Ireland
The EU MDR and IVDR apply in Northern Ireland and CE marking is required. Where a UK-based notified body is used, a combined CE and UK(NI) marking is required. Devices with the combined marking can be placed across the UK but are not accepted on the EU market.
CE marking and UKCA marking: what is the difference?
CE marking is used under applicable EU product legislation. UKCA is available for certain goods, including medical devices, placed on the Great Britain market. UKCA is not recognised for the EU, EEA or Northern Ireland markets.
CE marking and medical device manufacturing
CE marking responsibilities sit with the legal manufacturer, but contract manufacturing decisions can influence the evidence and controls needed to support conformity.
Europlaz is a UK medical device contract manufacturer. Services include design for manufacture, precision injection moulding, cleanroom assembly, process validation, quality assurance and supply chain management.
Looking for a UK medical device manufacturing partner?
Europlaz can review the manufacturing stage, processes and production requirements for your device.
Frequently asked questions about CE marking
What does CE marking mean?
It indicates that the manufacturer declares that a product meets applicable EU requirements following the required conformity assessment.
Is CE marking mandatory?
Only for products covered by EU rules that require it.
Who is responsible for CE marking?
The manufacturer is responsible for conformity and affixing the marking.
Is there a CE certificate?
There is no central EU body issuing a general CE-marking certificate. A notified body may issue relevant conformity-assessment certificates where required.
Can a manufacturer self-certify?
Only where the applicable legislation and conformity assessment route permit self-assessment.
Is CE marking recognised in Great Britain?
Yes, for qualifying medical devices under current transitional arrangements.
Does Europlaz provide CE certification?
Europlaz is a medical device contract manufacturer, not an EU notified body. Europlaz’s has experience supporting medical CE marking and can apply to relevant notified bodies as part of its service.
Can Europlaz obtain a CE mark on someone’s behalf?
Europlaz can support customers through aspects of the CE marking process and can submit applications to relevant notified bodies.
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