Is Your Software a Medical Device? Get Certainty with an MDR Assessment
Understand if your product falls under MDR and what to do next
Don't guess your MDR path. In just a few hours, we help you understand where your product stands and help to move forward without unnecessary costs. Our MDR Assessment provides clear product qualification and Rule 11 classification and a MDCG guidance aligned action plan.
Get a Clear Understanding of Your MDR Status
Know exactly whether your product qualifies as a medical device and what MDR classification it falls under. This removes uncertainty and let's you start.
Focus on What’s Required Now and in the Future
Receive a tailored, staged action plan designed for your maturity. This help's moving forward while ensuring long-term alignment with MDR compliance.
Turn Your MDR Assessment Into a Strategic Asset
Use your documented classification and roadmap to align with investors and partners. Use your credibility and clear regulatory doubts early in your journey.
How Our MDR Assessment Creates Clarity & Direction in 3 Steps
1. Get Clarity Qualification & Classification
We start by reviewing your product’s intended use, architecture and claims to determine whether it qualifies as a medical device and if so, the MDR risk class. This establishes the regulatory baseline.
2. Map Out Regulatory Implications
We clarify what your classification means in terms of the required documentation, clinical evidence and Notified Body involvement. This gives you a clear view of what is required now, what can wait and what can be avoided.
3. Define
a Strategic Action Plan
You will receive a written MDR roadmap detailing the next steps, key risks and decision points. This will be your compass, guiding your development and supporting funding, planning and partner conversations.
What We Work Through During Your MDR Assessment
This is the core of our MDR Assessment. We use a structured framework to guide your decision-making and regulatory strategy.
That way, you focus on the right questions and develop a clear, well-prioritised approach to navigating MDR.
1. Clarify Intended Use & Product Scope
We work with your team to define your product's medical function, how it interacts with users and the claims being made. This forms the basis for all subsequent MDR decisions.
2. Qualification & Classification (Rule 11)
We determine if your software qualifies as a medical device, applying MDR classification logic, particularly Rule 11, to establish the correct risk class and the Notified Body involvement implications, timelines and evidence.
3. Gap Mapping vs. MDR Requirements
We assess what documentation, processes and strategies already exist and what is missing, across Annex I, Annex II/III, clinical evaluation and PMS. You will know what is urgent, what can wait and what is not worth.
4. Regulatory Impact & Roadmap
We help you understand the practical implications of your classification, what is required now and in the future, and how this relates to your product, team, and funding goals.
MDR Concerns You Can Put to Rest
This is where many teams hesitate.
MDR seems confusing or risky.
Acting without clarity feels unsafe.
Heading Down the Wrong Classification Path
You're not sure if your software or device qualifies as a medical device. Once this has been clarified, your next steps will be clear. No speculation anymore.
Being Classified Too High and therefore Costly
You worry about landing in Class IIb or higher when it may not be necessary. A grounded Rule 11 analysis avoids overclassification and reduces unnecessary cost and risk.
No Visibility Into What’s Missing in Documentation
You don’t know what documentation or processes would be required for your product. An assessment shows you what is needed, what not and what to do next.
Wasting Time
on the Wrong Work and Priorities
Teams often either overbuild or underprepare and nobody wants to be next. Gaining early insight into MDR expectations allows you to prioritise what matters most right now.
Investors and Partners asking about MDR
Being asked about CE marking or MDR compliance, but not quite ready to answer. An assessment provides a defensible plan, giving more confidence and preparation.
What Will You Leave With After the MDR Assessment
MDR classification often feels like a black box. You will leave our MDR Assessment with clarity and structure.
Qualification & Risk Class Snapshot
You will Know whether your product qualifies as a medical device and its risk class (based on Rule 11 and MDCG 2019-11). This will be invaluable for product planning, internal alignment and funding.
MDR Gap Snapshot & Priority Map
You will know all critical gaps in your documentation, technical setup and risk management approach, ranked by urgency. You plan now what needs building now, what can wait and where effort is wasted.
Next-Step Roadmap & Support
You will receive a list of actions relating to your product and business priorities. These include engaging a Notified Body, starting documentation and approaching evidence and developing a QMS.
See MDR Pre-Assessment based Development Success Stories
What do our Clients Think About our Guiding MDR Assessment
Asterisk
Veronica Kirin, Founder & CEO
Imaginary
Lucia Pannese, CEO
Natal Mind
Aura Pyykönen, MD PhDWho Will Guide You Through the MDR Assessment
Josua Ziegler
CEO
10 years of experience in startup and corporate strategy consulting.
Led digital transformation projects across health, finance and sports in Europe and Middle East.
Christopher Taylor
Sr. Product Manager
Over 10 years experience in product and project management.
Led multiple startup and enterprise-level products in emerging technologies such as AI, automation and VR.
Krzysztof Radecki
CTO
18 years of R&D and technology project leadership experience.
Led tech implementations at Opel, GE Money Bank, CGI, JLL, and Infomotion GmbH.
Lukasz Fedorowicz
Workshop & Design Expert
More than 20 years of experience in digital design, user experience and workshop facilitation.
Designed and launched digital products across Scandinavian and international markets.
Clients We’ve Already Worked With
Your FAQs for our MDR Assessment
Q1: What’s the difference between an assessment and full MDR certification?
A1: An assessment helps you understand how the MDR applies to your product before you commit to the cost of full certification. It provides a clear plan of action and sets out your priorities, eliminating the need for full technical documentation or involvement of a Notified Body.
Q2: Can this help us decide whether we’re a medical device under MDR?
A2: Yes. We will assess whether your product qualifies as a medical device under the MDR, including software under Rule 11. Based on your intended use and system functionality, you’ll receive a defensible position.
Q3: How long does an MDR Assessment take?
A3: Most assessments can be completed in 1–2 weeks, depending on product complexity and availability of documentation. We keep the process lean and decision-focused.
Q4: Do we need to have a QMS or technical documentation already?
A4: No, an assessment is especially useful if you don’t yet have a QMS or full documentation. We’ll evaluate your current processes and provide recommendations tailored to your development level.
Q5: Will this give us a clear classification under Rule 11?
A5: Yes. We will map your features and claims against Rule 11 and MDCG 2019-11. You will leave with a classification rationale that you can use for planning purposes and in future discussions with the Notified Body.
Q6: What happens after the MDR Assessment? Do you help with the rest as well?
A6: If you decide to proceed, punktum can support you throughout the entire MDR process, including the creation of technical documentation, setting up a QMS and preparing for certification.
Q7: What if our product is borderline between wellness and medical?
A7: That’s exactly what the MDR Assessment resolves. We clarify how your intended use and features are interpreted under the MDR, helping you to determine whether certification is required and avoid over-regulation.
