Most startups treat EU MDR like a compliance project that starts “later.” The teams that move faster treat it like a product roadmap: clear milestones, owners, and “unblockers” that reduce rework.
If you’re new to MDR, start with the overview here.
And if you’re still shaping claims, read intended purpose first (because roadmap decisions start with words).
Why a roadmap beats a checklist
A checklist mindset creates two classic problems:
– You build features first, then discover the evidence burden later.
– You “finish” documents twice because the strategy wasn’t stable.
A roadmap mindset forces early alignment on:
– Intended purpose and claims
– Likely classification and conformity route
– Evidence strategy (clinical + V&V)
– Notified Body timing (if applicable)
The 8-milestone MDR roadmap (startup-friendly)
Think of these as your “release plan” for compliance.
Milestone 1: Intended purpose + boundaries are stable
Deliverables:
– 1-page intended purpose draft
– Clear boundaries (“not intended for”)
Definition of done:
– Your team can explain the medical purpose in one sentence without changing it every week.
Milestone 2: Classification + conformity assessment route confirmed
Deliverables:
– Classification rationale (Annex VIII rule(s) + justification)
– Decision: self-certification vs Notified Body
Definition of done:
– You can map the class to a realistic timeline and budget.
Milestone 3: QMS scope and “minimum viable processes” in place
Deliverables:
– Document control
– Design controls (design inputs/outputs, reviews, changes)
– Supplier controls (especially cloud/outsourced dev)
Definition of done:
– You can show controlled requirements, changes, and records from day one.
Milestone 4: Technical documentation structure created (Annex II/III)
Deliverables:
– Tech Doc index (table of contents + where each document lives)
– GSPR checklist skeleton
Definition of done:
– You’re not “writing a Tech File”; you’re building a system of linked documents.
Milestone 5: Risk management is integrated into development
Deliverables:
– Risk management plan + file (ISO 14971 aligned)
– Traceability to requirements and tests
Definition of done:
– Risks are not a standalone spreadsheet; they drive design decisions and verification.
Milestone 6: Evidence plan locked (V&V + clinical)
Deliverables:
– V&V plan (what you must prove, how, and when)
– Clinical evaluation plan outline
Definition of done:
– Every claim has an evidence route (test, literature, clinical data, usability, cybersecurity, etc.).
Milestone 7: Notified Body engagement (if needed)
Deliverables:
– NB shortlist and outreach
– Submission readiness plan (what you’ll have by which date)
Definition of done:
– You’re not waiting until “we’re ready”; you’re planning around lead times.
Milestone 8: Submission package readiness + launch monitoring plan
Deliverables:
– Finalized Tech Doc set for review
– PMS plan (and PMCF if applicable)
– Vigilance + complaint handling processes
Definition of done:
– You can show not only “pre-market” readiness, but also how you’ll monitor safety/performance after launch.
Where startups lose time (and how to prevent it)
– Roadmap without owners: assign a single owner per milestone.
– No decision deadlines: set dates for intended purpose freeze, classification decision, and evidence plan lock.
– Design freeze never happens: define what “freeze” means for your product (and what can still change).
– Notified Body treated as a late step: if you need one, it’s a timeline driver, not a formality.
A simple way to run this like a product team
Use a monthly “regulatory sprint review”:
1. What milestone are we in?
2. What’s blocked?
3. What decision must be made this month?
4. What evidence are we generating next?
Want a roadmap tailored to your device in 60 minutes?
If you want to map your MDR pathway to a realistic startup timeline (and avoid building the wrong evidence plan), book a free 60-minute MDR Strategy Call.
Book here: https://calendly.com/niko-mangold-consultants/30min