Turnkey CE marking for medical devices
CE marking is your gateway to the EU market, but under MDR, obtaining it requires considerably more than before. We take your device through to CE marking - from classification to the declaration of conformity.
You receive a justified device classification, conformity assessment route, technical documentation, quality management system and support with notified body assessment as one managed project.
Fixed project price and clear timeline - you know the cost before work begins.
How to proceed
Classification and route selection
Documentation and system
Assessment and certification
CE marking and market access
- No guesswork about device classification
- No incomplete documentation for assessment
- No surprises in notified body timelines
What does CE marking mean for a medical device?
CE marking is the manufacturer's own declaration that the device meets the requirements of MDR Regulation (EU) 2017/745 and that conformity has been assessed in the manner required for its device class. The marking is not an authorisation granted by an authority, but a conclusion for which the manufacturer is responsible. It must be supported by technical documentation, a quality management system and, except for Class I devices, a certificate issued by a notified body. Affixing the marking is the final stage of the process, not the first.
Responsibility lies with the manufacturer
No one grants CE marking on your behalf. The manufacturer declares conformity and remains responsible for it throughout the device life cycle.
The device class determines the route
The rules in Annex VIII determine whether the device is Class I, IIa, IIb or III, and the class determines whether a notified body is required and which assessment procedure applies.
The marking is supported by evidence
Each general safety and performance requirement in Annex I must be demonstrated as fulfilled through documented evidence, not simply claimed.
CE marking is not a stamp but the outcome of a chain in which classification, evidence, documentation and the system support one another.
We take the project through, so you do not have to
Obtaining CE marking requires regulatory expertise, documentation work and experience of how notified bodies operate. Few manufacturers have all of this in-house. We handle the work and need from you the information about your device and its intended purpose.
We classify the device according to the rules in Annex VIII and justify the classification
We select the conformity assessment route and prepare a project plan
We build the technical documentation, GSPR matrix and quality management system
We support you in selecting the notified body, during the audit and in responding to requests for additional information
You do not need to memorise the regulation or guess what the assessor expects to see.
The path to CE marking, step by step
Below is the route every manufacturer follows. Its scope and duration vary by device class, but the order of the stages is the same - and work done in the wrong order often has to be redone.
Device definition and classification
First, it must be determined whether the product is a medical device, what its intended purpose is and which class it belongs to under the rules in Annex VIII. This decision guides everything else.
- Intended purpose, indications, target group and use environment documented
- Classification according to the rules in Annex VIII, with justification - for software, particularly Rule 11
- Distinction from other product categories, such as wellness products and accessories
Incorrect classification is the most costly mistake because it is often only discovered during assessment.
Selecting the assessment route
The class determines the procedure. For Class I devices, the manufacturer may declare conformity itself, while Class Is, Im, Ir, IIa, IIb and III devices require the involvement of a notified body under Annexes IX, X or XI.
- Applicable annex and procedure selected and justified
- Need for a notified body, its designation scope and a realistic timeline established
- Impact of transitional provisions and any existing certificate assessed
Notified body waiting lists are long, so the route should be confirmed early.
Quality management system
MDR requires manufacturers to have a quality management system, which in practice is implemented in accordance with ISO 13485. The system must be operational before the audit, not merely documented on paper.
- Design controls, purchasing, production and control of nonconformities described
- Person responsible for regulatory compliance (PRRC) appointed
- Evidence of system use: records, reviews and internal audit
The auditor does not assess your instructions, but whether you follow them.
Technical documentation
Technical documentation in accordance with Annexes II and III is at the core of CE marking. It demonstrates that the device meets the general safety and performance requirements and that risks are under control.
- Device description, design documentation, manufacturing information and GSPR matrix
- Risk management file, verification and validation, and clinical evaluation
- Labelling, instructions for use and post-market surveillance plan
Documentation must be consistent throughout - the assessor cross-references it.
Assessment, declaration and marking
The notified body audits the system and assesses the technical documentation. Once the certificate has been obtained, the manufacturer prepares the EU declaration of conformity and affixes the CE marking.
- Audit, documentation assessment and responses to requests for additional information
- EU declaration of conformity in accordance with Annex IV
- CE marking in accordance with Annex V, including the notified body's identification number
The marking may only be affixed once conformity has been fully demonstrated.
Registrations and placing on the market
Before sales begin, the device and manufacturer must be registered and traceability must be arranged. This stage also marks the start of ongoing obligations that do not end with CE marking.
- Actor registration and SRN, device Basic UDI-DI and UDI-DI, and EUDAMED data
- Authorised representative for non-EU manufacturers and allocation of responsibilities in distribution agreements
- PMS system, PMCF and, depending on class, PSUR and incident reports
CE marking is the start of an ongoing obligation, not the end point of the project.
We turn these stages into one project plan in which every document has an owner, deadline and place in the overall process.
What CE marking delivers for you
The marking opens up the market, but a well-executed project also creates a structure on which future products and versions can be built quickly.
Access to the EU market
Without CE marking, a device cannot be placed on the market in the EU. With the marking, sales, distribution and public procurement become accessible.
Credibility in the eyes of buyers
Hospitals, distributors and procurement organisations request the certificate and declaration before making a purchase decision - they are sales arguments, not merely obligations.
A structure for future products
Once established, the system and documentation framework also support product family extensions and version updates.
The same material supports certification, sales and the next round of product development.
Who is our CE marking service for?
Our service is intended for manufacturers of medical devices and software that need CE marking for the EU market or need to transition from a directive-era marking to MDR.
It is particularly suitable when:
We help both startups certifying their first device and established manufacturers transitioning their product families to MDR.
How we take your device to CE marking
You do not build the marking as a project on your own. We take it through clear stages, so you always know where things stand and what comes next.
Assessment and classification
We review the device, its intended purpose and your existing materials, classify the device and select the assessment route. You receive a clear view of what is missing and what it will cost.
“Route and scope confirmed before work begins.”
Documentation and system
We build the technical documentation, GSPR matrix, risk management and clinical evaluation, as well as a quality management system ready for audit.
“We write, you confirm.”
Assessment and marking
We support you through notified body assessment and requests for additional information, prepare the declaration of conformity and handle UDI and EUDAMED registrations.
“Marking affixed, markets open.”
We also agree how the documentation and surveillance will be kept up to date after marking.
The most common mistakes in CE marking projects
The same mistakes recur from one project to another, and almost all of them cost time precisely at the final stage. They can be avoided when the order is right.
Documentation starts too late
Technical documentation is only assembled once the product is complete, by which time evidence from the design phase no longer exists in a traceable form.
Classification is not justified
The class is selected based on preference rather than the rules in Annex VIII, and the entire assessment route proves to be incorrect midway through the project.
Marking without a system
CE marking is affixed without an operational quality management system and market surveillance, meaning obligations are neglected immediately after marking.
The assessor is not looking for a perfect product, but for a consistent chain from requirement to evidence.
Fixed price, predictable project
We price the CE marking project based on the device classification and starting point. You know the cost before work begins.
Fixed project price for the agreed scope
Clearly defined scope and delivery schedule
Scope scaled according to the device risk class
Post-marking maintenance and surveillance agreed separately
You receive a quotation showing what will be done, by when and what it will cost.
Why MDRpankki?
We have taken devices through to CE marking for both companies certifying their first product and established manufacturers, so we know where projects fail.
Regulatory expertise
We know the MDR annexes, classification rules and notified body expectations in practical terms, not merely as regulatory text.
Turnkey delivery
We are responsible for the outcome, not just the hours worked: documentation, the system and support until the marking is affixed.
Practical approach
We adapt the system to your size and way of working so that it can also be maintained after the project.
Your team focuses on the product; we ensure that conformity is demonstrated.
Talk to an MDR expert
Together, we will assess your device classification, assessment route and what CE marking specifically requires from you.
Frequently asked questions about CE marking
- CE marking is the manufacturer's own declaration that the device meets the requirements of MDR Regulation (EU) 2017/745. The marking is not granted by an authority or a notified body; the manufacturer affixes it after preparing the EU declaration of conformity. Except for Class I devices, a certificate from a notified body is required before the marking can be used, and the body's four-digit identification number must also appear alongside the marking.
- It depends on the device class. For Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments, the manufacturer may declare conformity itself. Classes Is, Im, Ir, IIa, IIb and III require a notified body. For Classes Is, Im and Ir, its assessment only covers sterility, measuring function or reusability. We determine the class and route during the assessment before work begins.
- For a Class I device, the full process can be completed in a few months because no notified body is needed. For Class IIa devices and above, a realistic duration is typically around one to two years, with a significant part spent in the notified body's queue and assessment process. The timeline is most affected by the starting state of the documentation, the sufficiency of clinical evidence and how quickly requests for additional information are answered.
- The cost consists of two parts: our project work and the notified body's own fees, which the body invoices directly to the manufacturer. We price our part as a fixed project price based on the device class and starting point, so you know it before work begins. Notified body fees depend on the class and the body, and we estimate them during the assessment together with the rest of the project.
- Software is a medical device if the manufacturer intends it, for example, for diagnosis, treatment monitoring, prognosis or supporting treatment decisions. Rule 11 in Annex VIII of MDR significantly raised software classifications compared with the directive era, and many software products previously in Class I now fall under Class IIa or higher. Classification is always based on intended purpose, so documenting it precisely is the first stage of the work.
- The marking does not end the work. The manufacturer must maintain the quality management system, update the technical documentation and clinical evaluation, collect information from the market through the PMS system and PMCF, and report incidents to the authority. For Class IIa devices and above, a periodic safety update report (PSUR) must also be prepared. The notified body also carries out annual surveillance audits throughout the validity of the certificate.
What does CE marking mean for a medical device in practice?+
Do we need a notified body?+
How long does it take to obtain CE marking?+
How much does CE marking cost?+
Is software a medical device and which class does it belong to?+
What obligations remain after CE marking?+
Explore also
MDR requirements, quality management, risk management and clinical evidence form one whole. Learn more about each element.
MDR regulation (2017/745)
What the regulation requires from manufacturers, how devices are classified and which route demonstrates conformity.
Read more →ISO 13485 quality management system
The quality management system required by MDR in practice: processes, documentation and audit readiness.
Read more →ISO 14971 risk management
The risk management file, risk assessment and control measures throughout the device's entire life cycle.
Read more →Clinical evaluation
Collection of clinical evidence, the CER report and PMCF as part of the technical documentation.
Read more →