Turnkey Medical Device CE Marking
CE marking is your gateway to the EU market, but under MDR it requires significantly more than before. We take your device all the way to marking – from classification to declaration of conformity.
You will receive device classification with justification, conformity assessment route, technical documentation, quality management system, and support with the notified body assessment as one managed project.
Fixed project price and clear schedule – no hourly fees or surprises.
How to proceed
Classification and route selection
Documentation and system
Assessment and certification
CE marking and market launch
- No guesswork about device class
- No incomplete documentation for assessment
- No surprises in notified body schedules
What does CE marking in a medical device mean?
CE marking is the manufacturer’s own assurance that the device meets the requirements of MDR Regulation (EU) 2017/745 and that conformity has been assessed as required by the device class. The marking is not a permit issued by authorities but a conclusion made by the manufacturer, 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 last step in the process, not the first.
Responsibility lies with the manufacturer
No one issues the CE marking on your behalf. The manufacturer guarantees conformity and is responsible for it throughout the device’s lifecycle.
Device class determines the route
Annex VIII rules define class I, IIa, IIb, or III, determining whether a notified body is required and which assessment procedure applies.
Marking is evidence-based
Every general safety and performance requirement in Annex I must be demonstrated with documented evidence, not just claims.
CE marking is not a stamp but the result of a chain where classification, evidence, documentation, and system support each other.
We carry out the project, so you don’t have to
Obtaining CE marking requires regulatory expertise, documentation work, and experience with notified bodies. Few manufacturers have all this in-house. We handle the work and need only information from you about the device and its intended use.
We classify the device according to Annex VIII and justify the class
We select the conformity assessment route and prepare a project plan
We create technical documentation, GSPR matrix, and quality management system
We support you in selecting the notified body, audits, and responses to supplement requests
You don’t have to memorize the regulation or guess what the assessor expects to see.
Step-by-step CE marking path
Below is the route every manufacturer goes through. Scope and duration vary by device class, but the order of steps is the same—and work done in the wrong order often must be redone.
Device definition and classification
First, it must be determined whether the product is a medical device, its intended purpose, and which class it falls under according to Annex VIII rules. This decision guides everything else.
- Intended purpose, indications for use, target group, and usage environment documented
- Classification according to Annex VIII rules with justifications – especially rule 11 for software
- Distinction from other product categories like wellness products and accessories
Incorrect classification is the most costly mistake, as it is revealed only during assessment.
Choice of assessment route
Class determines the procedure. Class I devices can be self-certified by the manufacturer, whereas classes Is, Im, Ir, IIa, IIb, and III require notified body involvement following Annexes IX, X, or XI.
- Applicable annex and procedure selected and justified
- Notified body necessity, scope, and realistic schedule clarified
- Impact of transition rules and any existing certificate evaluated
Notified body queues are long, so it is best to finalize the route early.
Quality management system
MDR requires the manufacturer to have a quality management system, generally implemented according to ISO 13485. The system must be operational before the audit, not just on paper.
- Description of design control, procurement, production, and deviation management
- Person responsible for conformity (PRRC) appointed
- Proof of system use: records, reviews, and internal audits
The auditor does not evaluate instructions but whether you follow them.
Technical documentation
Technical documentation per Annexes II and III is the core of CE marking. It demonstrates the device meets general safety and performance requirements and that risks are controlled.
- Device description, design data, manufacturing information, and GSPR matrix
- Risk management file, verification and validation, and clinical evaluation
- Labels, user manual, and post-market surveillance plan
Documentation must be internally consistent—the assessor cross-references it.
Assessment, declaration, and marking
The notified body audits the system and reviews the technical documentation. Once the certificate is obtained, the manufacturer drafts the EU declaration of conformity and affixes the CE marking.
- Audit, documentation review, and responses to supplement requests
- EU declaration of conformity compliant with Annex IV
- CE marking in accordance with Annex V, including notified body identification number
Marking may only be affixed once conformity is fully demonstrated.
Registrations and market launch
Before sale, the device and manufacturer must be registered, and traceability arranged. This stage also marks the start of ongoing obligations beyond marking.
- Operator registration and SRN code, device Basic UDI-DI and UDI-DI, and EUDAMED data
- Authorized representative for non-EU manufacturers and responsibility sharing in distribution agreements
- PMS system, PMCF, and depending on class, PSUR and vigilance reporting
CE marking is the start of continuous obligations, not the project endpoint.
We build these stages into one project plan where every document has an owner, deadline, and place in the whole.
What CE marking delivers to you
The marking opens the market, but a well-executed project also creates a structure on which subsequent products and versions can be quickly built.
Access to the EU market
Without CE marking, the device cannot be marketed in the EU. With marking, sales, distribution, and public procurement open up.
Credibility in the buyer’s eyes
Hospitals, distributors, and procurement units request certificates and assurances before purchase – they are sales arguments, not just obligations.
Framework for future products
Once established, the system and documentation base also support product family expansions and version updates.
The same materials serve certification, sales, and the next product development cycle.
Who is our CE marking service for?
Our service is intended for manufacturers of medical devices and software who need CE marking for the EU market or who must transition from directive-based marking to MDR.
It is especially suitable for situations where:
We help both startups certifying their first device and established manufacturers transitioning product families to MDR.
How we carry your device through CE marking
You don’t build the marking yourself as a project; we carry it out in clear phases. You always know where we are and what the next step is.
Mapping and classification
We review the device, intended purpose, and existing materials, classify the device, and select the assessment route. You get a clear picture of what is missing and what it costs.
“Route and scope defined before work begins.”
Documentation and system
We build the technical documentation, GSPR matrix, risk management and clinical evaluation, and prepare the quality management system for audit.
“We write, you confirm.”
Assessment and marking
We support you during notified body assessment and supplement requests, prepare the declaration of conformity, and handle UDI and EUDAMED registrations.
“Marking applied and market opened.”
We also agree on how the documentation and monitoring remain up to date after marking.
Most common mistakes in CE marking projects
The same mistakes repeat project to project, and almost all cost time especially at the final phase. They are avoidable when the order is correct.
Documentation started too late
Technical documentation is only assembled once the product is finished, leaving no traceable evidence from the design phase.
Unjustified classification
Class is chosen based on wish not Annex VIII rules, and the entire assessment route turns out to be wrong mid-project.
Marking without a system
CE marking is affixed without a functioning quality management system and market surveillance, leading to neglected obligations immediately after marking.
The assessor does not look for a perfect product but a consistent chain from requirement to evidence.
Fixed price, predictable project
We price the CE marking project based on device classification and starting point. You will know the cost before work begins.
Fixed project price with no hourly fees
Clearly defined scope and delivery schedule
Scope scaled according to device risk class
Post-marking maintenance and monitoring agreed separately
You receive a quote showing what is done, timeframe, and cost.
Why MDRpankki?
We have brought devices to marking for both companies certifying their first product and established manufacturers, so we know where projects typically fail.
Regulatory expertise
We know MDR annexes, classification rules, and notified body expectations on a practical level, not just as text in a regulation.
Turnkey solution
We don’t sell hours but results: documentation, system, and support until the marking is in place.
Pragmatism
We adapt the system to your size and way of working, so it is maintainable even after the project.
Your team focuses on the product; we ensure conformity is demonstrated.
Discuss with an MDR expert
Let's map your device classification, assessment route, and what CE marking requires from you together.
Frequently Asked Questions about CE marking
- CE marking is the manufacturer’s own assurance that the device meets MDR Regulation (EU) 2017/745 requirements. The marking is not granted by an authority or notified body but affixed by the manufacturer after drafting the EU declaration of conformity. Except for class I devices, marking requires a notified body certificate and displays the body’s four-digit ID number.
- It depends on the device class. Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments can be self-certified by the manufacturer. Classes Is, Im, Ir, IIa, IIb, and III require a notified body, though for Is, Im, and Ir the assessment focuses only on sterility, measuring function, or reusability. We determine the class and route in the initial mapping before starting work.
- Class I devices can be completed in a few months since no notified body is needed. For classes IIa and above, a realistic timeline is typically one to two years, with a significant portion spent waiting for and undergoing notified body assessment. Schedule depends mainly on documentation status, adequacy of clinical evidence, and speed of responses to supplement requests.
- The cost consists of two parts: our project work and the notified body fees, which the body bills directly to the manufacturer. We price our part as a fixed project fee based on device class and starting point, so you know it before work starts. The notified body fees depend on class and body and are estimated during mapping together with the whole scope.
- Software is a medical device if intended by the manufacturer, for example, for diagnosis, treatment monitoring, prediction, or decision support. MDR Annex VIII rule 11 raised software classification significantly compared to the directive era, so many software products formerly class I are now class IIa or higher. Classification is always based on intended use, so precise documentation of that is the first step.
- Marking does not end the work. The manufacturer must maintain the quality management system, update technical documentation and clinical evaluation, collect market data via PMS and PMCF, and report incidents to authorities. For classes IIa and above, periodic safety update reports (PSUR) must also be prepared. Notified bodies conduct annual surveillance audits during certificate validity.
What does CE marking mean in practice for a medical device?+
Do we need a notified body?+
How long does CE marking take?+
What does CE marking cost?+
Is software a medical device and what class does it belong to?+
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Also Explore
MDR requirements, quality management, risk management, and clinical evidence form a complete whole. Learn more about their components.
MDR Regulation (2017/745)
What the regulation requires from the manufacturer, how devices are classified, and the route to demonstrate compliance.
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
Risk management file, risk assessment, and control measures throughout the device's lifecycle.
Read more →Clinical Evaluation
Collecting clinical evidence, CER report, and PMCF as part of the technical documentation.
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