EU MDR (Medical Device Regulation) & Classification Consulting Services
Plan Your MDR Compliance Based on Expert Classification
Although many teams understand the need for MDR compliance, they often don’t know where to start or how to classify their product correctly. Our EU MDR consulting service helps you assess your product, determine its classification and plan your compliance steps with clarity.
Clarify Your Medical Device Classification from the Start
Understand exactly how your software or device fits into EU MDR categories. This saves time, avoids missteps and gives you a clear regulatory pathway.
Avoid Unnecessary Medical Device Classification
Assess your product’s real-world application and intended use. You stay out of MDR scope when possible and prevents moving into higher risk classes.
Full Product, Documentation and Regulation Alignment
Work with our MDR consultants to define your classification early and accurately. This brings clarity, speeds up planning, and ensures full regulatory alignment.
Our EU MDR Consulting & Classification Helps You Forward in 3 Steps
1. Evaluate MDR Relevance for Your Product
We assess whether your product qualifies as a medical device under EU MDR and clarify what specific obligations apply to your case. This avoids delays, costs and ensures you're on the right regulatory path from the start.
2. Identify Gaps and Build a Compliance Plan
We review your current documentation and processes, uncover gaps and create an actionable plan to meet MDR requirements. This helps you reduce risk of rejections and work more efficiently toward compliance.
3. Classify and Strategize Your Certification
We define your correct MDR risk class based on intended use, software function and invasiveness. This enables you to plan your development, certification and go-to-market strategy with precision.
Your EU MDR Consulting & Classification Roadmap
This is the core of our EU MDR Consulting service. We apply a structured framework in our EU MDR consulting and classification services to guide your product from initial evaluation to full certification readiness. You gain clarity on your regulatory status, a clear plan of action and a robust pathway to compliance.
1. Determine Your MDR Applicability
We start by verifying whether your software or device qualifies as a medical device under EU MDR. This includes assessing intended use, user interaction and the decision logic involved.
2. Define Your Risk Class
Once qualification is confirmed, we determine your product’s correct risk classification (Class I, IIa, or IIb). This step shapes your entire regulatory path and helps avoid unnecessary classification burdens or scope creep.
3. Identify Documentation & Process Gaps
We review your current documentation, processes, and team setup. Like this, you are mapping missing elements, for example, TechDoc structure or QMS requirements. Focus your effort where it's needed most.
4. Document & Process Alignment
We ensure your classification decision, product documentation and operational processes are fully aligned with MDR requirements: from TechDoc and SOPs to QMS certification. This coherence mitigates risks of non‑conformity and supports smoother notified body interactions.
5. Notified Body Engagement & Updates
We guide you through the selection of an appropriate notified body, prepare submission documentation, support you in EUDAMED registration, and establish ongoing post‑market surveillance (PMS). This ensures your regulatory compliance evolves alongside your product lifecycle.
Want to Know in Detail How We Guide You Through EU MDR Classification and Certification?
If you're ready to dive deeper, we’ve outlined exactly how our EU MDR consulting services help take your product from initial assessment to full certification. From classification to technical documentation and notified body communication for your medical device.
See How Our MDR Process Works in DetailMDR Concerns You Can Put to Rest
Hesitation to act on EU MDR classification?
It’s often because the risks feel unclear.
Our MDR consulting solves this.
Being Placed in a higher Risk Class than Necessary
Misclassifying software or devices leads to complex obligations. Starting MDR classification correctly avoids too much regulatory effort and enables achievable certification.
Costs Escalating due to new MDR Requirements
Regulation requires upgrades across QMS, clinical evidence and supply chains. You stay in control by breaking this into phased, manageable steps and avoid budget surprises.
Missing Data and System compliance Duty
MDR demands attention to data protection, cyber-security and interoperability. Observing these risks secures approval and can lead to early compliance in the process.
Slow Approvals & Bottlenecks with Notified Bodies
Notified body reviews are often delayed due to missing details or unclear documentation. Well-prepared submission speeds up evaluation and keeps your go-to-market timeline real.
Regulatory Changes or Lack internal Expertise
Delays often come from uncertainty around the latest MDR changes or a lack of internal expertise. Up-to-date consulting lets your team move forward with confidence.
What Will You Leave With after our EU MDR Consulting?
After working through our EU MDR classification and compliance process, you leave with your flushed out plan.
EU MDR Classification Report
A summary that outlines your product's medical device status and risk class. You’ll know exactly how your software or device is regulated and which obligations apply.
MDR Gap Analysis Summary
A structured overview of gaps in tech doc, QMS or development process. You’ll see what’s already compliant as well needing to be updated before certification.
Full Technical Documentation Package
A ready-to-submit package prepared according to MDR Annex II and III. It includes all required materials, and you’ll be ready to engage your Notified Body directly.
Innovations we've helped to develop
Medical Devices & Medical Software we make EU MDR compliant
AI-Driven Diagnostics
- Medical Imaging Analysis Tools
- Wearable Health Monitors
- Cardiovascular Diagnostic Devices
- Respiratory Diagnostic Tools
- Dermatology Diagnostic Apps
- Neurological Diagnostic Tools
Digital Therapeutics
- Diabetes Management Apps
- Cognitive Behavioral Therapy (CBT) Apps
- Mood and Anxiety Trackers
- Alcohol and Drug Addiction Recovery Programs
- Post-Surgery Recovery Apps
- Chronic Pain Management Tools
- ADHD Management Apps
Remote Patient Care
- Telemedicine Platforms
- Remote Monitoring Devices
- Emergency Response Systems
- Medication Adherence Tools
- Home-Based Lab Testing Kits
- Remote Rehabilitation Tools
- Sleep Monitoring Devices
Telemedicine
- Virtual Consultation Platforms
- Digital Patient Engagement Solutions
- Online Booking Apps
- Telehealth Software with EHR Integration
- Remote Patient Monitoring Systems
- Portable Telemedicine Kits
- Connected Health Kiosks
What do our Clients Think About our EU MDR Consulting
DiaperID
Prof. Dr. Philip Bufler, MD
Imaginary
Lucia Pannese, CEO of Imaginary
Natal Mind
Aura Pyykönen, MD PhD
attuned
Ariana Chemtob, Founder of AttunedMeet our Medical Device Classification Consultants
Josua Ziegler
CEO of punktum
10 years of experience in startup and corporate strategy consulting.
Led digital transformation projects across health, finance and sports in Europe and Middle East.
Krzysztof Wolk, PhD.
10+ years of experience in NLP, AI research and Machine Learning.
Bridges academic research with real-world business applications, delivering AI solutions that improve operations and decision-making.
Clients We’ve Already Worked With
How Our Service: Medical Device Classification Process Works
From initial device qualification to full technical documentation and certification
We're with you every step of the way on your journey to full MDR compliance, including all the technical documents and certification milestones. Our ISO 13485- and ISO 27001-certified engineering team handles everything you need for EU MDR compliance under one roof.
A. Initial Assessment and Planning
Device Qualification and Classification:
We begin by verifying whether your product qualifies as a medical device under EU MDR. If it does, we classify it into the correct risk class (Class I, IIa, or IIb), based on intended use, invasiveness and duration of contact. This sets the foundation for your regulatory path and ensures you're not overclassified.
Gap Analysis:
Next, we analyse your current documentation, quality processes and development workflows. We look at your technical documentation (TechDoc) and Quality Management System (QMS) against MDR expectations to identify missing elements or weaknesses that could delay certification.
MDR Criteria Evaluation for Software:
For medical device software, we apply the MDCG 2019-11 rules. We assess intended use, operating principles and data interaction to define if and how the software contributes to diagnosis, monitoring or treatment.
A.1. Medical Device Qualification & Classification
Intended Use of the Device or Software:
This refers to the medical purpose your product serves, such as diagnosis, monitoring, or treatment. The intended use must be defined, as it is the primary factor influencing classification and regulatory requirements.
Operating Principle of the Device:
The operating principle describes how the product functions from a technical perspective, processing patient data, delivers therapy, or interfaces with other devices and their contribution to a medical outcome.
Role in the Clinical Workflow:
Here, the assessment identifies where the product fits within the broader healthcare delivery process, whether it's supporting clinicians, enabling remote monitoring, or providing automated decision support.
A.2. EU MDR Gap Analysis
Technical Documentation Review:
We assess your current documents (MDR Annex II & III) for completeness, accuracy and compliance. This includes your design files, risk analysis, clinical evidence and post-market surveillance plans.
Quality Management System (QMS) Check:
Your QMS is reviewed against ISO 13485 standards and MDR-specific obligations. We evaluate areas such as document control, traceability, corrective actions and validation processes.
Safety, Performance & Risk Criteria Alignment:
A Review of your development practices to align with the General Safety and Performance Requirements (GSPRs) in Annex I of the MDR. This includes risk-benefit analysis, usability, labelling and verification processes.
A.3. MDR Criteria Evaluation for Software
Evaluation Under MDCG 2019-11:
For software, MDCG 2019-11 guidance is applied to determine if it qualifies as a Medical Device Software (MDSW). The criteria assess whether the software performs actions on medical data, such as analysis, interpretation, or decision support, that directly impact clinical outcomes.
B. Remediation and Development of MDR aligned Medical Devices
Once the gaps have been identified, the next step is implementing the required changes to bring your medical device product into full EU MDR compliance. This stage ensures all technical documentation and quality systems are properly aligned with the regulation before certification.
B.1. Technical Documentation and QMS Setup
eQMS System Implementation:
An eQMS centralises and standardises all quality-related documents, tracking user actions to ensure only validated processes are followed, supporting audit readiness and MDR traceability requirements.
ISO 13485-Compliant Quality Management:
This quality management framework defines how medical devices are designed, developed and maintained. Document control and risk management ensures consistent product quality and regulatory alignment.
Creation of MDR-Compliant TechDocs:
Technical Documentation is compiled according to MDR Annex II and III, structured to prove the product safety, performance and clinical benefits.
Standard Operating Procedures (SOPs):
SOPs are step-by-step guides to critical tasks. These documents ensure repeatability, compliance and alignment with QMS and MDR expectations.
B.2. IEC 62304 Compliant Software & Hardware Development Lifecycle
IEC 62304-Aligned Development Process:
This standard governs the full software lifecycle: planning, requirements to design, implementation, testing, release, and maintenance. Every step must be documented and risks controlled.
Usability Engineering (IEC 62366-1):
Usability is addressed by identifying potential errors: interface design or workflow. This process includes research, prototyping, formative evaluations and final validation, then qualified as safe and effective.
Cybersecurity and Data Protection Measures:
Security requirements are embedded into process, in line with MDCG 2019-16, ISO 27001 and TIR57 guidelines. Including threat modeling, access control, data encryption, secure data storage, response planning.
Verification & Validation Activities (V&V):
V&V confirms the product was built correctly. Verification confirms that requirements are implemented and validation confirms the system meets user needs, confirmed through test protocols, matrices and reports.
C. Notified Body Engagement
Selection and Communication:
We help you select the most suitable Notified Body based on your product’s risk class and technology. Together, we define timelines, expectations and the right communication approach to prevent misunderstandings and delays.
Submission Preparation:
We take care of preparing and structuring your full MDR submission package, ensuring every file, form and piece of evidence is complete, correct and compliant before it’s sent to the Notified Body for review.
D. Implementation and Monitoring
QMS Implementation:
We support you in implementing necessary QMS improvements, including team onboarding, SOP development and tool integration. This ensures your system meets ISO 13485 and MDR-specific requirements while fitting seamlessly into your existing operations.
EUDAMED Registration:
We register your medical devices in the EUDAMED database, handling data preparation and system entry. This guarantees you meet mandatory MDR transparency and traceability obligations without hassle.
E. Ongoing Support and Training
CAPA and PMS/PMCF:
Corrective and Preventive Actions (CAPA) and Post-Market Surveillance (PMS) are essential to keeping your medical device compliant after launch. We support your team in managing non-conformities, conducting root cause analyses and implementing effective risk mitigation based on real-world product data.
Continuous Improvement:
Your team needs to stay current with evolving MDR regulations. We provide ongoing training on regulatory updates, documentation procedures and best practices, so you stay prepared for audits and maintain high compliance standards long after certification.
Punktum is a RAPS Member
Membership of the Regulatory Affairs Professionals Society (RAPS) connects us to the latest regulatory standards and industry practices. This membership ensures that our clients receive expert advice and the latest knowledge for seamless MDR compliance, improving the quality and safety of their medical devices and software.
