Does Your Digital Health Product Fall Under MDR? Find Out in 60 Minutes.
Why Early MDR Clarity Is a Strategic Advantage
Most teams don't set out to build a medical device. But MDR exposure is driven by what a product does, not what you call it. A feature addition or an AI-generated output can shift your regulatory position immediately. Early clarity is important for product decisions, timelines and freedom to build.
Unintentional Classification
- A wellness app that tracks symptoms can qualify as a medical device
- Intended use and claims matter more than product category
- Many teams only discover this during due diligence or funding rounds
Changes Trigger Reclassification
- Adding a risk score or clinical recommendation shifts the MDR class
- A single UI change can move classification from Class I to Class IIa
- Reclassification mid-development is expensive and disruptive
AI Features Carry Regulatory Weight
- AI-generated outputs that influence clinical decisions are MDR-relevant
- Summarisation of patient data is not automatically outside MDR scope
- The regulatory impact depends on what the output is used for
Clarity Now and Fewer Problems
- Late regulatory discovery forces costly redesigns and delays
- Investors and partners increasingly ask about MDR status early
- Knowing the own position enables to build with confidence and speed
How Our MDR Triage Sprint for Healthcare Products Works in 3 Steps
1. You Share
Your Briefing Package
Before the session, you send us your intended use, a feature overview and your open questions. This allows us to prepare a focused, structured review and make the most of the 60 minutes together.
2. A 60-Minute Structured Session
We walk through your claims, functionality and workflow context together. We assess your intended use language, feature-level MDR exposure signals and user context to determine your regulatory position.
3. Written
Output
Delivered
Within 24–48 hours you receive a clear written MDR position statement, identified risk signals and a recommended next step with rationale. This will be useful for your team, investors and partners to rely on.
What Is Included in the MDR Triage Sprint for Healthcare Products?
A focused, fixed-price session designed to give you a clear MDR position fast.
Here is exactly what you get for 1,900 €.
What's Included:
- Review of intended use and claims language
- Analysis of feature-level MDR exposure signals
- User and workflow context assessment
- AI summarisation and automation risk check
- Written MDR position statement Identified risk signals
- Recommended next step with rationale
How It Works:
You share a briefing package ahead of the call: intended use, feature overview and open questions.
60-minute structured session: we walk through claims, functionality and workflow context together.
Written expert output delivered within 24–48 hours.
At a Glance:
60 Minutes + Remote + 1,900 €
Book Your MDR Triage Sprint
See Our MDR based Development
Success Stories
What do our Clients Think About our MDR Triage Sprint for Healthcare
Asterisk
Veronica Kirin, Founder & CEO
Imaginary
Lucia Pannese, CEO
Natal Mind
Aura Pyykönen, MD PhD
Our Guides for Your MDR Triage Sprint for Healthcare Products
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.
Clients We’ve Already Worked With
Your FAQs for our MDR Triage for Healthcare Products
Q1: What exactly is the MDR Triage Sprint for Digital Health Products?
A1: It is a focused 60-minute session with a punktum MDR expert, followed by a written output delivered within 24–48 hours. It is designed to tell you whether your product is MDR-relevant, where your exposure lies and what to do next.
Q2: Who is this MDR Triage Sprint for Digital Health designed for?
A2: It is designed for founders and product teams with a digital health product who are unsure whether MDR applies to them. If MDR is an open question for your team, this is the right starting point.
Q3: What do we need to prepare before the session?
A3: Ahead of the call, you will share a briefing package with us, including details of your intended use, a feature overview and your open questions. This enables us to conduct a targeted review and make the most of our 60-minute session.
Q4: What triggers MDR relevance for a digital health product?
A4: The relevance of your product to MDR is determined by what it does, not what you call it. Key triggers include software that performs calculations or risk scoring, AI-generated outputs that influence clinical decisions, patient-specific recommendations and features that support diagnosis or therapy. The intended use of the product and marketing claims also play a significant role.
Q5: Is this the same as a full MDR assessment?
A5: No. The Triage Sprint is scoped to answer one question: are you MDR-relevant and where are your boundaries? If a deeper assessment is needed, we will recommend the right next step at the end of the session.
Q6: What are the typical next steps after a Triage Sprint for Healthcare Products?
A6: Depending on the maturity and exposure of your product, the next most common step is an MDR Risk & Readiness Deep Dive. This is a structured assessment that provides a defensible classification position, a complete register of MDR exposure risks and a regulatory action plan. For products approaching launch, however, a full MDR risk assessment may be more appropriate.
Q7: Can we use the written output in investor or partner conversations?
A7: Yes, the written position statement provides documented, defensible MDR guidance that can be referenced during funding or partnership discussions. Many digital health investors and corporate partners now require MDR clarity before they will engage in serious conversations. Having a documented position demonstrates that you have assessed your exposure, understand your boundaries and have a plan, which is often enough to take the conversation forward.
