Full MDR Regulation (2017/745) Compliance Delivered Turnkey
The MDR Regulation defines what a medical device must meet to enter the EU market. We clarify what the regulation requires for your specific device and handle 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 – no hourly fees or surprises.
How to proceed
Classification and Requirement Analysis
Documentation Plan
Documents Prepared for You
Ready for CE Marking
- No interpretation uncertainty
- No months-long documentation effort
- No disconnected documents
What is the MDR Regulation?
MDR, or the EU Medical Device Regulation (2017/745), replaced the previous Medical Device Directive, significantly tightening requirements. It is directly applicable law across all EU countries and covers every device placed on the EU market. In practice, MDR expanded the scope, raised the clinical evidence standards, and extended the manufacturer's responsibility to cover the entire product lifecycle.
Broader Scope
The regulation also includes products previously outside regulation, with many devices upgraded to higher risk classes during the transition.
Stronger Clinical Evidence
Clinical evaluation must be based on sufficient data. Relying on equivalence is now clearly more restricted.
Full Lifecycle Oversight
Responsibility does not end at CE marking: post-market surveillance and reporting are ongoing obligations.
MDR is not a one-off documentation project but a permanent requirement reflected in both documents and practical operations.
We Make MDR Requirements Understandable and Documented
The MDR text is extensive and open to interpretation. We translate it into a concrete checklist of what exactly needs to be done for your device and produce the necessary documents ready for submission.
We determine the device classification and applicable requirements
We prepare the technical documentation according to Annexes II and III
We develop clinical evaluation aligned with risk management
We support you with notified body questions and requests for additional information
You don’t need to interpret the regulation yourself or guess if your documentation suffices for evaluation.
What MDR Practically Requires
MDR requirements form a cohesive whole, with all parts aligned. Below are the areas every manufacturer must have in order before CE marking.
Classification and Scope
The device’s risk class determines the extent of requirements and whether notified body involvement is needed. Classification is based on the rules in Annex VIII and must be justified.
- Precise definition of intended purpose
- Risk class determination according to Annex VIII rules
- Selection of applicable conformity assessment route
Classification defines how extensive the documentation and assessment requirements will be for you.
Technical Documentation
The technical file is the core of MDR compliance. It describes the device, its design, manufacturing, safety, and demonstrates conformity with general safety and performance requirements.
- Device description, variants, and manufacturing details
- Matrix of general safety and performance requirements
- Verification, validation, and applied standards
The technical file is the material reviewed by the notified body line-by-line.
Clinical Evaluation
Clinical evaluation shows that the benefits of the device outweigh the risks and that performance matches the intended use. It is based on literature, own data, or clinical study.
- Clinical evaluation plan and data search
- Evidence assessment and benefit-risk 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 System
MDR requires documented risk management throughout the lifecycle and a quality management system. In practice, this is implemented following ISO 14971 and ISO 13485 standards.
- Risk management plan and file according to ISO 14971
- Quality management system built on ISO 13485 structure
- Links between risks, requirements, and documentation
Risk management must also be evident in technical documentation and instructions for use.
Post-Market Surveillance
CE marking does not end obligations. MDR requires planned collection of market data, regular reporting, and incident notification to authorities.
- PMS plan and PMCF plan
- Periodic safety reviews and PMS reports
- Incident and corrective action procedures
Information from surveillance continuously updates clinical evaluation and risk management.
We build these areas into a unified whole where documents consistently reference each other.
What Compliance Brings You
Meeting MDR requirements is not just an obligation but a prerequisite for market access and credibility.
Access to EU Markets
CE marking according to MDR 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 purchase.
Operational Continuity
Up-to-date documentation handles audits and regulatory inspections without last-minute rushes.
When documentation is done right the first time, it also supports product development, sales, and internationalization.
Who Is Our MDR Service For?
Our service is for medical device manufacturers, importers, and distributors who must demonstrate compliance with the MDR Regulation.
It is especially suitable when:
We assist equally startups certifying their first device and manufacturers with multiple product lines.
Path to CE Marking
We deliver compliance through clear steps, keeping you informed at every stage about progress and your responsibilities.
Requirement Analysis
We determine device classification, applicable requirements, assessment route, and review existing materials.
“Clear understanding of requirements and gaps.”
Documentation Preparation
We write the technical file, clinical evaluation, risk management, and surveillance plans according to agreed schedule.
“We write, you approve.”
Assessment and Marking
We support you during the notified body’s assessment, respond to additional information requests, and finalize the declaration of conformity.
“The package withstands scrutiny.”
We also agree on how to keep the documentation up to date after marking.
Common Mistakes in MDR Projects
The same issues recur in assessments year after year. They are avoidable if the whole process is properly planned from the start.
Starting Too Late
Documentation begins only after product completion, making it impossible to retrospectively gather missing data.
Weak Clinical Evidence
Over-reliance on equivalence or literature search that does not withstand critical review.
Inconsistent Documents
The intended use, risk assessment, and instructions for use tell different stories, almost certainly leading to requests for additional information.
Consistency between documents is as important as the content of individual documents.
Fixed Price, Predictable Project
We price MDR documentation as a project based on device classification and scope. You know the cost before work begins.
Fixed project price without hourly fees
Clearly defined scope and delivery schedule
Scope sized by device risk class
Maintenance and updates agreed separately
You receive an offer detailing what will be done, when, and at what cost.
Why Choose MDRpankki?
We combine regulatory expertise with ready-made structures, enabling faster documentation than starting from scratch.
Regulatory Expertise
We know the MDR Regulation, harmonized standards, and notified bodies’ practical expectations.
Turnkey Solution
We don’t sell hours but a finished result: documentation ready for assessment.
Practical Approach
We create documentation that reflects your real operations and doesn’t just sit on the shelf.
Your team focuses on the product; we take care of compliance.
Talk to an MDR Expert
Let’s map out your device classification and what the MDR Regulation specifically requires for your product together.
Frequently Asked Questions About the MDR Regulation
- MDR (Regulation 2017/745) is EU legislation defining safety and performance requirements for medical devices. In practice, manufacturers must document device safety, clinical benefit, and manufacturing control before CE marking and monitor the device throughout its lifecycle on the market.
- Yes. Devices certified under the previous directive must transition to MDR requirements within set timelines. Extended deadlines set by Regulation (EU) 2023/607 are staggered by device class: transition ends on 31.12.2027 for Class III and implantable Class IIb devices (excluding example products) and on 31.12.2028 for other Class IIb, Class IIa, and Class I devices requiring notified body assessment. Transition for individually manufactured Class III implants ended on 26.5.2026. Extensions require no significant device changes and timely notified body review requests as stipulated in the regulation. Practically, transition involves updating technical documentation, clinical evaluation, and quality system to MDR level, often more extensive than manufacturers anticipate.
- Not always. For Class I devices that are not sterile, measuring, or reusable surgical instruments, manufacturers can self-declare conformity. All other classes require notified body assessment. It is important to confirm classification carefully as it determines the entire project scope.
- Typically from a few months up to about a year. Schedule depends on device risk class, clinical evidence status, and existing documentation volume. Notified body assessment adds additional time, so starting well ahead of planned market entry is advisable.
- MDR is mandatory legislation defining what must be achieved. ISO 13485 is a voluntary standard describing how to build a quality management system. MDR requires a QMS but does not name the standard, and ISO 13485 has become the accepted way to demonstrate that requirement is met.
- Yes. This is the core of our service. We need information about your device, its intended use, and manufacturing, after which we write the documentation complete. You review and approve the final result, and we support you during notified body assessment as well.