MDR regulation (2017/745) requirements delivered turnkey
The MDR regulation defines what is required of a medical device on the EU market. We determine what the regulation requires specifically for your device and prepare the required documentation for you.
You receive technical documentation, clinical evaluation, risk management and post-market surveillance as one complete package that withstands notified body assessment.
Fixed project price and clear schedule - you know the cost before work begins.
How it works
Classification and requirements analysis
Documentation plan
Documents prepared for you
Ready for CE marking
- No uncertainty over interpretation
- No months-long documentation effort
- No disconnected documents
What is the MDR regulation?
MDR, the EU regulation on medical devices (2017/745), replaced the previous Medical Devices Directive and significantly tightened requirements. The regulation is directly applicable legislation in all EU countries and applies to every device placed on the EU market. In practice, MDR expanded the scope, raised the required level of clinical evidence and extended the manufacturer's responsibility to cover the entire product life cycle.
Broader scope
The regulation also covers products that were previously outside the scope of regulation, and the risk class of many devices increased during the transition.
Stronger clinical evidence
Clinical evaluation must be based on sufficient data. Reliance on equivalence is considerably more limited than before.
Monitoring throughout the life cycle
Responsibility does not end with CE marking: post-market surveillance and reporting are ongoing obligations.
MDR is not a one-off documentation project, but a permanent requirement that must be evident in both documents and day-to-day operations.
We make MDR requirements understandable and documented
The text of the MDR regulation is extensive and open to interpretation. We turn it into a concrete list of what needs to be done specifically for your device and produce the documents through to completion.
We determine the device classification and applicable requirements
We prepare technical documentation in accordance with Annexes II and III
We align clinical evaluation and risk management
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 documentation is sufficient for assessment.
What MDR requires in practice
MDR requirements form a whole in which all elements must be aligned. Below are the areas every manufacturer must have in place before CE marking.
Classification and scope
The device risk class determines the extent of requirements and whether a notified body is needed for assessment. Classification is based on the rules in Annex VIII of the regulation and must be justified.
- Precise definition of the intended purpose
- Determination of the risk class under the rules in Annex VIII
- Selection of the applicable conformity assessment route
Classification determines the extent of documentation and assessment required from you.
Technical documentation
The technical file is at the core of MDR compliance. It describes the device, its design, manufacture and safety, and demonstrates fulfilment of the general safety and performance requirements.
- Device description, variants and manufacturing information
- General safety and performance requirements matrix
- Verification, validation and applied standards
The technical file is the material the notified body reviews line by line.
Clinical evaluation
Clinical evaluation demonstrates that the benefits of the device outweigh its risks and that its performance corresponds to its intended purpose. It is based on literature, proprietary data or a clinical investigation.
- Clinical evaluation plan and literature search
- Evidence assessment and benefit-risk ratio justification
- Clinical evaluation report and update cycle
Insufficient clinical evidence is the most common reason for requests for additional information during assessment.
Risk management and quality management system
MDR requires documented risk management throughout the entire life cycle and a quality management system. In practice, these are implemented in accordance with ISO 14971 and ISO 13485.
- Risk management plan and file in accordance with ISO 14971
- Quality management system structured in accordance with ISO 13485
- Links between risks, requirements and documentation
Risk management must also be reflected in technical documentation and instructions for use.
Post-market surveillance
CE marking does not end the obligations. MDR requires systematic collection of market data, regular reporting and reporting of incidents to the competent authority.
- PMS plan and PMCF plan
- Periodic safety update reports and PMS reports
- Procedures for incidents and corrective actions
Information generated through surveillance continually updates the clinical evaluation and risk management.
We build these areas into a coherent whole in which the documents refer to one another consistently.
What compliance delivers for you
Meeting MDR requirements is not merely an obligation, but a prerequisite for market access and trust.
Access to the EU market
CE marking in accordance with the MDR regulation opens the entire EU market for your device without country-specific barriers.
Credibility with buyers
Hospitals, distributors and procurement units require verifiable compliance as a condition for purchasing decisions.
Business continuity
Up-to-date documentation withstands audits and authority inspections without urgent projects.
When documentation is in order from the outset, it also supports product development, sales and international expansion.
Who is our MDR service for?
Our service is intended for manufacturers, importers and distributors of medical devices who need to demonstrate compliance with MDR requirements.
It is particularly suitable when:
We help both start-ups certifying their first device and manufacturers with several product families.
The path to CE marking
We take you through compliance in clear stages, so you always know where you stand and what is required from you.
Requirements analysis
We determine the device classification, applicable requirements and assessment route, and review your existing materials.
“A clear view of requirements and gaps.”
Preparing documentation
We prepare the technical file, clinical evaluation, risk management and surveillance plans within the agreed schedule.
“We write, you approve.”
Assessment and marking
We support you during notified body assessment, respond to requests for additional information and finalise the declaration of conformity.
“A complete package that withstands review.”
We also agree how the documentation will be kept up to date after marking.
The most common mistakes in MDR projects
The same issues recur in assessments year after year. They can be avoided when the whole is planned correctly from the start.
Starting too late
Documentation is only started once the product is complete, when missing data can no longer be gathered retrospectively.
Limited clinical evidence
Equivalence is relied on too lightly, or the literature search does not withstand critical review.
Inconsistent documents
The intended purpose, risk assessment and instructions for use tell different stories, which almost certainly leads to a request for additional information.
Consistency between documents is just as important as the content of individual documents.
Fixed price, predictable project
We price MDR 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 scaled according 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 ready-made structures, so documentation is completed faster than when starting from scratch.
Regulatory expertise
We understand the MDR regulation, harmonised standards and notified body expectations in practical terms.
Turnkey delivery
We take responsibility for the outcome, not just hours worked: documentation that is ready for assessment.
Practical approach
We create documentation that reflects your actual operations rather than being left on a shelf.
Your team focuses on the product, while we take care of compliance.
Talk to an MDR expert
Together, we will assess your device classification and what the MDR regulation requires specifically from your product.
Frequently asked questions about MDR
- MDR (Regulation 2017/745) is EU legislation that defines safety and performance requirements for medical devices. In practice, it means that before CE marking, the manufacturer must document the device's safety, clinical benefit and control of manufacturing, and monitor the device on the market throughout its entire life cycle.
- Yes. Devices certified under the previous directive must be brought within the scope of MDR requirements during the transition periods. The deadlines extended by Regulation (EU) 2023/607 are staggered by device class: for Class III devices and Class IIb implantable devices, the transition period ends on 31 December 2027 (excluding, for example, sutures, staples and dental fillings), while for other Class IIb and Class IIa devices, as well as Class I devices requiring notified body assessment, it ends on 31 December 2028. The transition period for custom-made Class III implants already ended on 26 May 2026. The extensions are conditional: they require, among other things, that no significant changes have been made to the device and that the manufacturer has applied for notified body assessment within the deadlines specified in the regulation. In practice, the transition means updating technical documentation, clinical evaluation and the quality management system to MDR level, which is often a more extensive task than manufacturers anticipate.
- Not always. For Class I devices that are not sterile, measuring or reusable surgical instruments, the manufacturer may draw up the declaration of conformity independently. A notified body is required for assessment in all other classes. Classification should be verified carefully, as it determines the scope of the entire project.
- Typically, from a few months to around a year. The schedule is affected by the device risk class, the state of clinical evidence and how much documentation already exists. Notified body assessment takes additional time, so it is worth starting well before the intended market launch.
- MDR is mandatory legislation that defines what must be achieved. ISO 13485 is a voluntary standard that describes how to build a quality management system. MDR requires a quality management system without naming the standard, and ISO 13485 is in practice the established way to demonstrate that this requirement has been met.
- Yes. That is the core of our service. We need information from you about the device, its intended purpose and manufacture, after which we prepare the documentation to completion. You review and approve the result, and we also support you during notified body assessment.
What does the MDR regulation mean in practice?+
Does MDR also apply to older devices already on the market?+
Is a notified body always required?+
How long does it take to prepare MDR documentation?+
What is the difference between MDR and ISO 13485?+
Can you prepare all the documentation for us?+
Explore also
MDR requirements, quality management, risk management and clinical evidence form one whole. Learn more about each element.
CE marking
Classification, conformity assessment route, notified body and EU declaration of conformity.
Read more →MDR documentation
Technical documentation, the GSPR matrix and the documentation required under Annexes II-III as one whole.
Read more →ISO 13485 quality management system
The quality management system required by MDR in practice: processes, documentation and audit readiness.
Read more →Clinical evaluation
Collection of clinical evidence, the CER report and PMCF as part of the technical documentation.
Read more →