MDR Documentation Written for You
The MDR regulation requires extensive, consistent documentation from every medical device. We prepare it for you from start to finish.
You receive the technical documentation, GSPR compliance matrix, clinical evaluation, risk management, and post-market surveillance as an integrated package that withstands notified body assessment.
Fixed project price and clear schedule – no hourly fees or surprises.
How to Proceed
Current State and Gap Analysis
Documentation Plan
Documentation Writing
Ready for Assessment
- No own documentation workload
- No empty templates
- No contradictions between documents
What Does MDR Documentation Mean?
MDR documentation is the material with which a manufacturer demonstrates that their device meets the requirements of Regulation (EU) 2017/745. It is not a single document but a comprehensive set: technical documentation according to Annexes II and III, clinical evaluation, risk management, instructions for use and labeling, and post-market surveillance. The notified body assesses the entirety – the quality of a single document is not sufficient if parts contradict each other.
Broader Than Under the Directive
MDR increased requirements especially regarding clinical evidence, traceability, and information from the market.
Parts Must Align
The intended purpose must be consistent in the risk analysis, clinical evaluation, and instructions for use.
Living Material
The documentation is updated throughout the device’s lifecycle based on product changes, feedback, and follow-up data.
Assessment rarely fails due to a single document – it almost always fails due to lack of consistency across the whole.
We Write the Documentation, You Don’t
Most manufacturers have product knowledge but lack time and regulatory resources to write hundreds of pages in regulatory language. We do the writing for you and only need device information from you.
We review your existing material and identify missing parts
We write the technical documentation according to 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 don’t need to interpret the regulation yourself or guess if the material is sufficient for assessment.
What the Documentation Includes
Below are the sections every manufacturer must complete. Scope varies by device class, but the structure is the same.
Device Description and Classification
Documentation starts with what the device is, its intended purpose, and risk classification. The classification determines the rigour of required documentation.
- Intended use, indications for use, and target user group
- Classification according to Annex VIII rules with justification
- Product versions, variants, accessories, and Basic UDI-DI
Incorrect classification distorts the entire documentation scope.
Technical Documentation and GSPR
Annexes II and III cover design, manufacturing, verification, and validation. The GSPR matrix shows how each general safety and performance requirement is met.
- Design and manufacturing details, applied standards
- Verification and validation data, preclinical tests
- GSPR matrix with references to evidence
The GSPR matrix is the assessor’s primary tool – it should be done thoroughly.
Risk Management
ISO 14971 compliant risk management file covers hazard identification, risk evaluation, control measures, and residual risk justification relative to clinical benefit.
- Risk management plan and acceptability criteria
- Hazard analysis and verification of control measures
- Residual risks and benefit-risk assessment
Risk management must be reflected in instructions for use and clinical evaluation.
Clinical Evaluation
Clinical evaluation compiles evidence on device safety and performance and assesses its sufficiency. It is the MDR area most prone to requests for additional information.
- Clinical evaluation plan and literature search
- Evidence assessment and possible equivalence justification
- Clinical evaluation report and identified gaps
Equivalence-based evidence requires significantly stronger justification under MDR than before.
Labeling and Instructions for Use
Device labeling, packaging, and instructions for use are part of compliance. They must correspond with the intended use, risk analysis, and language requirements of target markets.
- Labels, symbols, and UDI carrier
- Contents of instructions for use and communicating residual risks
- Language versions according to target markets
Instructions for use are often the only documentation the end user sees.
Post-Market Surveillance
PMS plan, PMCF, and reporting describe how accumulated information is gathered and evaluated. Devices class IIa and higher require a PSUR.
- PMS plan and data collection sources
- PMCF plan and assessment report
- PMS report or PSUR and vigilance reporting procedure
A plan isn’t enough – assessment asks what has been done with gathered data.
We integrate these sections into a coherent whole where intended use, risks, and evidence are traceable throughout the entire documentation.
What Completed Documentation Delivers for You
Documentation is not just a requirement but a prerequisite for market access and often a sales argument.
Market Access
Without compliant documentation, the device cannot be CE marked or placed on the EU market.
More Time for Your Product Team
Your experts participate only where their product knowledge is needed – we do the writing.
Smoother Assessment
Consistent and traceable documentation reduces requests for additional information and shortens assessment lead times.
When documentation is right the first time, it also supports product development, sales, and internationalization.
Who Is Our Documentation Service For?
Our service is designed for medical device and software manufacturers who must demonstrate MDR compliance to a notified body or authority.
It is especially suitable when:
We assist startups certifying their first device as well as manufacturers of multiple product families.
How We Build Your Documentation
You don’t create the documentation yourself as a project. We complete it in clear stages. You always know what has been done, what’s missing, and what’s next.
Assessment
We review your device, risk class, and existing material, and define what MDR specifically requires from your product.
“Clear picture of requirements and gaps.”
Documentation Preparation
We write the technical documentation, GSPR matrix, clinical evaluation, and risk management using ready-made structures and expert work.
“We write, you approve.”
Review and Assessment Support
We review the complete package, finalize gaps, and support you during notified body assessment and information requests.
“A package ready for scrutiny.”
We also agree on how to keep the documentation up-to-date with product changes and follow-up data.
Common Mistakes in MDR Documentation
The same shortcomings recur in assessments year after year. They are avoidable when the material is planned as a whole from the start.
Incomplete Templates
Buying a document package that is left unfilled – assessment immediately reveals what hasn’t been written for the device.
Thin Clinical Evidence
Clinical evaluation relies on equivalence without sufficient justification or access to the comparator device’s data.
Inconsistent Intended Use
Intended use recorded differently across documents 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 device classification and scope. You know the cost before work begins.
Fixed project price with no hourly fees
Clearly defined content and delivery schedule
Scope scaled according to device risk classification
Maintenance and updates agreed separately
You receive a quote showing what is done, in what timeframe, and at what cost.
Why MDRpankki?
We combine regulatory expertise and ready-made structures, so documentation is created faster than starting from scratch.
Regulatory Expertise
We know the MDR regulation, harmonized standards, and notified body expectations at a practical level.
Turnkey
We don’t sell hours but a finished result: assessment-ready documentation.
Practical Approach
We make documentation that reflects your actual operations rather than gathering dust on a shelf.
Your team focuses on the product, we take care of regulatory documentation.
Talk to an MDR Expert
Let’s map out your current documentation status and what MDR specifically requires from your device together.
Frequently Asked Questions about MDR Documentation
- The complete package includes technical documentation according to Annexes II and III, a GSPR compliance matrix, risk management file, clinical evaluation, labeling and instructions for use, as well as post-market surveillance plans and reports. An EU declaration of conformity and, except for class I devices, a notified body assessment are also required. The parts must be aligned as the assessor reads them as a single entity.
- Yes. That is the core of our service. We need your device data, intended use, manufacturing details, and your experts’ participation in hazard identification, for example. We complete the rest of the writing. You review and approve the final product, and we also support you during assessment. Responsibility for compliance always remains with the manufacturer, so approval lies with you.
- Typically from a few months up to about a year. The timeline depends on the device’s risk class, clinical evidence status, and the amount of existing material. Notified body assessment also takes time, so starting well before intended market launch is advisable.
- Not as is. MDR raised requirements especially on clinical evidence, risk management, and post-market surveillance. Old material can often be used as a basis, but it must be supplemented and rebuilt into the MDR-required format. We review your existing material during the assessment and specify what can be reused.
- It depends on classification. Generally, manufacturers of class I devices can self-assess conformity. Sterile devices, those with measurement functions, reusable surgical instruments, and classes IIa, IIb, and III require notified body assessment. We determine classification during the assessment based on Annex VIII rules.
- Documentation must be kept up-to-date throughout the device’s lifecycle. Product changes, new clinical evidence, feedback, and incidents affect risk analysis, clinical evaluation, and PMS reporting. Maintenance is agreed separately: we can manage updates for you or train your team to do it themselves.