MDR & IVDR regulatory strategy

A regulatory strategy for Europe that also works for your product, your investors and the US.

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) raised the bar on evidence, classification and notified body scrutiny. We help medtech and diagnostics startups plan for them early, so regulation shapes the product rather than delaying it.

Why it matters

Under MDR and IVDR, early decisions carry late consequences.

Under MDR and IVDR, many products sit in a higher risk class than they would have under the old directives, and more of them need a notified body. Your intended-use statement, the claims in your marketing and the design of your software all affect that classification.

Notified body capacity is limited and reviews take time, so a weak technical file or an evidence plan that needs rework can cost months. For AI-based devices, the EU AI Act adds its own requirements on top.

The founders who move fastest decide their pathway before they lock the product, build their evidence plan around it, and can explain it clearly to investors.

What we help with

From classification to a submission-ready plan.

Classification and intended use

Assessing how your device or IVD is likely to be classified under MDR or IVDR, and how intended-use wording and product claims change the outcome.

Clinical and performance evidence

Planning the clinical evaluation (MDR) or performance evaluation (IVDR) evidence you need, and designing studies that also produce commercially useful data.

Technical documentation readiness

Mapping what your technical file and quality management system need to contain, and where the gaps are, before you engage a notified body.

Notified body preparation

Preparing for notified body engagement so the first review is as clean as possible and your timeline is realistic.

UK and US alignment

Planning UKCA and FDA routes alongside CE marking, so one evidence programme serves several markets where possible.

AI-based devices and the EU AI Act

For software and AI devices, aligning MDR or IVDR requirements with AI Act obligations and good machine learning practice.

Experience

Led by someone who has done it from the inside.

Marc Goldfinger, PhD, leads our regulatory work. He launched eight CE-marked AI-driven biomarkers for oncology and led an AI imaging platform through both FDA clearance and CE marking, managing a cross-functional team of twenty. He is a named inventor on a US patent for AI-driven biomarker detection and has published in Brain and Nature Communications.

GoldWhite provides strategic regulatory advisory. We are not a notified body, and our work does not replace formal conformity assessment. Where specialist regulatory, quality or legal services are needed, we will say so and help you engage them.

Who this is for

Medtech and diagnostics companies, before the expensive decisions.

  • Startups developing medical devices, software as a medical device or in vitro diagnostics
  • Teams that have not yet fixed their intended use, claims or evidence plan
  • Companies preparing to raise who need a credible regulatory story for investors
  • Founders planning EU, UK and US market entry and deciding what to do first

Want a fast, fixed-scope starting point? The three-week Regulatory Pathway Sprint covers classification, pathway options, evidence gaps and timeline.

See the Regulatory Pathway Sprint →

Map your MDR or IVDR pathway.

Book 30 minutes with a director. Tell us what you are building and where you want to sell it, and we will give you a straight view of the route ahead.

Book a Call →