MDR Compliance for Small Medical Device Manufacturers
Practical regulatory consulting to bring your Class I, IIa and IIb devices to the European market — without the overhead of a large consultancy.
MDR 2017/745 · ISO 13485 · ISO 14971
The challenge
Navigating MDR 2017/745 Shouldn’t Consume Your Resources
Regulation (EU) 2017/745 sets a high bar for every device on the EU market. Meeting it with a small team is a matter of method, not headcount.
A complex regulation
Step-by-step guidance: a clear view of which requirements apply to your device — and which don’t.
A limited budget
Tailored packages: fixed-price project quotes and monthly retainers sized for small teams. No hidden fees.
Tight timelines
A focused approach: work on what moves your device toward the market, nothing else.
Article 15
Article 15 Requires a PRRC. Hiring One Isn’t Your Only Option.
Article 15 of MDR 2017/745 requires every manufacturer to have a Person Responsible for Regulatory Compliance (PRRC). Micro and small enterprises are not required to hire one: they may appoint an external PRRC, provided that person is permanently and continuously at their disposal.
I serve as external PRRC for manufacturers and authorised representatives — qualified under Article 15 from day one.
The PRRC appointment does not transfer your legal responsibility as manufacturer. You remain solely responsible for the conformity of your devices.
Services
Compliance Projects
Defined scope, fixed-price quote, concrete deliverables. Six areas where your device moves forward.
MDR Compliance Consulting
Gap analysis, classification support and a regulatory roadmap: know exactly where your device stands, and what is left before CE marking.
Technical Documentation
Technical files structured to Annexes II and III of MDR 2017/745, ready for Notified Body review.
ISO 13485 Implementation
A quality management system (QMS) built for your size: documented, operational, audit-ready.
Risk Management (ISO 14971)
A complete risk management file: hazard identification, control measures, residual-risk evaluation and benefit-risk rationale.
EUDAMED Registration
Actor registration, device registration and UDI (Unique Device Identification) data in EUDAMED — completed, verified and maintained.
Post-Market Surveillance
Post-Market Surveillance (PMS) plans, vigilance procedures and Periodic Safety Update Report (PSUR) preparation that keep you compliant after launch.
The process
How It Works
1 · Free initial assessment
30 minutes on your device, your market and your current documentation.
2 · Gap analysis & roadmap
What is missing, what comes first, and realistic milestones.
3 · Implementation support
Documentation, QMS, risk management, registrations.
4 · Certification & market access
Support through conformity assessment to CE marking.
Typical timeline: 3–9 months, depending on device class, complexity and existing documentation.
The difference
Why Complimed
Built for small manufacturers
I work with teams under 50 people and design every deliverable around their constraints.
Pragmatic, not bureaucratic
Documentation that serves compliance, not paperwork for its own sake.
Transparent pricing
Fixed-price project quotes and monthly PRRC retainers. The model is public; the figure depends on your device portfolio. No hourly billing, no hidden fees.
From concept to market
One qualified contact through the whole journey, from classification to post-market.
Small manufacturers
Under 50 Employees? The Rules Are Written With You in Mind.
Micro and small enterprises — fewer than 50 employees and annual turnover or balance sheet total not exceeding €10 million (Recommendation 2003/361/EC) — may outsource the PRRC role instead of hiring. See what else changes for you.
Ready to Start?
Free 30-minute initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026