MDR documentation written for you
The MDR requires extensive, consistent documentation for every medical device. We prepare it for you from start to finish.
You receive technical documentation, a GSPR compliance matrix, clinical evaluation, risk management and post-market surveillance as one complete package that withstands notified body assessment.
Fixed project price and a clear schedule - you know the cost before work begins.
How it works
Assessment of the current state and gaps
Documentation plan
Documentation prepared for you
Ready for assessment
- No documentation burden for your team
- No blank templates
- No inconsistencies between documents
What does MDR documentation mean?
MDR documentation is the body of evidence through which a manufacturer demonstrates that its device meets the requirements of Regulation (EU) 2017/745. It is not a single document but a complete set: technical documentation in accordance with Annexes II and III, clinical evaluation, risk management, instructions for use and labelling, and post-market surveillance. The notified body assesses the complete set - the quality of an individual document is not enough if the parts are inconsistent.
More extensive than under the directives
MDR increased requirements especially for clinical evidence, traceability and information gathered from the market.
The parts must be consistent
The intended purpose must be stated consistently in the risk analysis, clinical evaluation and instructions for use.
Living documentation
Documentation is updated throughout the device life cycle as product changes, feedback and follow-up data emerge.
Assessments rarely fail because of one document - they almost always fail because the complete set lacks consistency.
We write the documentation, not you
Most manufacturers know their product but do not have the time or regulatory resources to write hundreds of pages in the language of the regulation. We do that work for you and only need device information from you.
We review your current material and identify missing elements
We prepare technical documentation in accordance with Annexes II and III
We connect risk management, clinical evaluation and GSPR
We support you with notified body questions and requests for additional information
You do not need to interpret the regulation yourself or guess whether the material is sufficient for assessment.
What the documentation includes
Below are the areas every manufacturer needs to address. The extent varies by device class, but the structure is the same.
Device description and classification
Documentation begins with what the device is, what it is intended for and which risk class it belongs to. Classification determines how extensive the required documentation will be.
- Intended purpose, indications and target population
- Classification under the rules in Annex VIII, with rationale
- Product versions, variants and accessories, and Basic UDI-DI
Incorrect classification puts the entire documentation at the wrong level.
Technical documentation and GSPR
Documentation in accordance with Annexes II and III covers design, manufacturing, verification and validation. The GSPR matrix demonstrates how each general safety and performance requirement is fulfilled.
- Design and manufacturing information, and standards applied
- Verification and validation evidence, including preclinical testing
- GSPR matrix with references to supporting evidence
The GSPR matrix is the assessor's first tool - it is worth preparing carefully.
Risk management
An ISO 14971-compliant risk management file covers hazard identification, risk assessment, risk control measures and justification of residual risks in relation to clinical benefit.
- Risk management plan and acceptability criteria
- Hazard analysis and verification of risk control measures
- Residual risks and benefit-risk ratio assessment
Risk management must also be reflected in the instructions for use and clinical evaluation.
Clinical evaluation
Clinical evaluation brings together evidence on the safety and performance of the device and assesses its sufficiency. It is the MDR area that most often leads to requests for additional information.
- Clinical evaluation plan and literature search
- Evaluation of evidence and, where applicable, equivalence rationale
- Clinical evaluation report and identified gaps
Evidence based on equivalence requires substantially stronger justification under MDR than before.
Labelling and instructions for use
Device labelling, packaging and instructions for use are part of conformity. They must correspond to the intended purpose, risk analysis and language requirements of target markets.
- Labelling, symbols and UDI carrier
- Contents of the instructions for use and communication of residual risks
- Language versions according to target markets
Instructions for use are often the only part of the documentation seen by the end user.
Post-market surveillance
The PMS plan, PMCF and reporting describe how accumulated information is collected and assessed. A PSUR is prepared for class IIa devices and above.
- PMS plan and data collection sources
- PMCF plan and evaluation report
- PMS report or PSUR, and incident reporting procedure
A plan is not enough - assessments ask what has been done with the information collected.
We build these elements into one coherent whole, where intended purpose, risks and evidence are traceable throughout the documentation.
What complete documentation delivers
Documentation is not just a requirement; it is a prerequisite for market access and often a sales argument as well.
Market access
Without compliant documentation, a device cannot be CE marked or placed on the EU market.
Your team's time for the product
Your experts only contribute where their product knowledge is needed - we handle the writing.
Smoother assessment
Consistent and traceable material reduces requests for additional information and shortens assessment lead times.
When documentation is right the first time, it also supports product development, sales and international growth.
Who is our documentation service for?
Our service is intended for manufacturers of medical devices and software that need to demonstrate MDR compliance to a notified body or authority.
It is particularly suitable when:
We support both startups certifying their first device and manufacturers with several product families.
How we build your documentation
You do not need to build documentation as a project yourself. We take it through clear stages. At all times, you know what has been completed, what is missing and what happens next.
Assessment
We review your device, risk class and existing material, and determine exactly what MDR requires for your product.
“A clear picture of requirements and gaps.”
Documentation preparation
We prepare the technical documentation, GSPR matrix, clinical evaluation and risk management using established structures and expert work.
“We write, you confirm.”
Review and assessment support
We review the complete set, finalise any gaps and support you during notified body assessment and requests for additional information.
“A complete set that withstands scrutiny.”
We also agree on how the documentation will be kept up to date as product changes and follow-up data emerge.
The most common mistakes in MDR documentation
The same shortcomings recur in assessments year after year. They can be avoided when documentation is planned as a complete set from the outset.
Uncompleted templates
A documentation package is purchased but left incomplete - the assessment immediately reveals what has not been written for the device.
Limited clinical evidence
The clinical evaluation relies on equivalence without sufficient justification or access to the comparator device documentation.
Inconsistent intended purpose
The intended purpose is stated differently in different documents, which almost certainly leads to a request for additional information.
Traceability from requirement to evidence is as important as the content of individual documents.
Fixed price, predictable project
We price documentation as a project based on the device classification and scope. You know the cost before work begins.
Fixed project price for the agreed scope
Clearly defined scope and delivery schedule
Scope tailored to the device risk class
Maintenance and updates agreed separately
You receive a proposal showing what will be done, by when and what it will cost.
Why MDRpankki?
We combine regulatory expertise with established structures, so documentation is completed faster than when starting from scratch.
Regulatory expertise
We understand the MDR, harmonised standards and notified body expectations in practical terms.
Turnkey service
We are accountable for the outcome, not just hours worked: documentation ready for assessment.
Practical approach
We prepare documentation that reflects your actual operations rather than something that remains on a shelf.
Your team focuses on the product, while we take care of regulatory documentation.
Talk to an MDR expert
Together, we will assess the current state of your documentation and what MDR specifically requires for your device.
Frequently asked questions about MDR documentation
- The complete set consists of technical documentation in accordance with Annexes II and III, a GSPR compliance matrix, a risk management file, clinical evaluation, labelling and instructions for use, as well as post-market surveillance plans and reports. An EU declaration of conformity is also required and, except for class I devices, notified body assessment. The parts must be consistent, as the assessor reads them as one complete set.
- Yes. That is the core of our service. We need information from you about the device, its intended purpose and manufacturing, as well as input from your experts, for example in hazard identification. We prepare everything else. You review and approve the outcome, and we also support you during the assessment. Responsibility for conformity always remains with the manufacturer, so approval is yours.
- Typically, from a few months to around a year. The schedule depends on the device risk class, the state of clinical evidence and how much material already exists. Notified body assessment takes additional time, so work should begin well before the planned market launch.
- Not as it stands. MDR increased requirements particularly for clinical evidence, risk management and post-market surveillance. Existing material can usually be used as a basis, but it must be supplemented and restructured into the format required by MDR. During the assessment, we review your current material and explain what can be used.
- It depends on the classification. Manufacturers of class I devices can usually carry out the conformity assessment themselves. Sterile devices, devices with a measuring function and reusable surgical instruments, as well as classes IIa, IIb and III, require notified body assessment. We determine the classification during the assessment based on the rules in Annex VIII.
- Documentation must be kept up to date throughout the device life cycle. Product changes, new clinical evidence, feedback and incidents affect the risk analysis, clinical evaluation and PMS reporting. Maintenance is agreed separately: we can handle updates for you or train your team to manage them independently.
What does MDR documentation include?+
Can you prepare the complete documentation for us?+
How long does it take to prepare the documentation?+
Is old documentation prepared under the directives sufficient?+
Do we need a notified body?+
How is documentation maintained after certification?+
Explore also
MDR requirements, quality management, risk management and clinical evidence form one whole. Learn more about each element.
Clinical evaluation
Collection of clinical evidence, the CER report and PMCF as part of the technical documentation.
Read more →ISO 14971 risk management
The risk management file, risk assessment and control measures throughout the device's entire life cycle.
Read more →ISO 13485 quality management system
The quality management system required by MDR in practice: processes, documentation and audit readiness.
Read more →CE marking
Classification, conformity assessment route, notified body and EU declaration of conformity.
Read more →