Netherlands-based. Europe-focused. Medical device market access.

EU market access support for medical device manufacturers

We help medical device manufacturers move from regulatory preparation to commercial market entry in the EU. That includes MDR-aware Technical Documentation and Notified Body submission support, specialist translations, EU-ready commercial materials, and targeted outreach to distributors, importers and market-entry partners across Europe. Clients work with us for the full EU market-access and go-to-market package, or for selected workstreams only.

Notified Body Submission Support Technical Translations & EU Materials Distributor & Importer Outreach

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For manufacturers preparing to enter, expand or professionalize their presence in EU markets.

Documentation readiness and commercial EU access belong together.

Prepare Package Connect

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EU market access Practical preparation for selected markets MDR-aware workflows Structured documentation and review coordination Multilingual documentation IFUs, labels, packaging and product information Qualified EU conversations Distributors, importers and commercial partners

What we do

Practical support across documentation readiness and EU commercial access.

We help medical device manufacturers remove avoidable friction from EU market entry. Our work sits between MDR-aware documentation, technical translation, market-entry preparation and commercial outreach.

MDR-aware documentation

We help structure, translate and align IFUs, labels, packaging text, product information, manuals and supporting documentation for EU market entry.

Technical translation & terminology

Medical device translations with terminology control, reviewer feedback loops and consistency across languages, claims, warnings and product descriptions.

Distributor-ready materials

We prepare clear commercial materials that help EU distributors, importers and partners understand the product, its use case, documentation status and market potential.

EU partner mapping

We identify relevant distributors, importers, specialist resellers, buying groups and commercial partners in selected EU markets.

Outreach & follow-up support

We help open qualified conversations with the right EU contacts and support the follow-up process with clear materials, structured communication and practical next steps.

Why this matters in medical devices

Language, claims and commercial readiness need to move together.

In EU medical devices, language is not just marketing. Documentation, instructions, warnings, labels and product claims need to be clear, consistent and controlled across markets. Poor translation or fragmented documentation can create unnecessary questions, delays and rework.

But EU market access does not stop once the documents are translated. Manufacturers also need to present the product clearly to the right distributors, importers, buying groups and commercial partners. That requires materials that are both technically credible and commercially usable.

Fewer preventable documentation questions

Cleaner multilingual document sets

Better handover to distributors, importers and reviewers

From documentation to market conversations

EU market access is not only a documentation challenge.

Once the product, claims, instructions and materials are clear enough for the European context, manufacturers still need to find the right commercial route into each market.

9hows MedDev helps bridge that gap. We support the documentation side and the commercial side: preparing the materials EU partners need, mapping relevant distributors and importers, and helping manufacturers open qualified conversations in selected European markets.

Prepare

Documentation, translations, terminology and product information aligned for EU market entry.

Package

Distributor-ready materials and market-entry files that explain the product clearly and professionally.

Connect

Targeted outreach to EU distributors, importers and commercial partners in selected markets.

Who we help

For medical device manufacturers with serious EU ambitions.

9hows MedDev is built for manufacturers that already have a product, a regulatory route and serious EU ambitions — but need a stronger documentation, language and commercial access process around market entry.

Non-EU manufacturers preparing for EU market entry European manufacturers expanding into additional EU countries Specialist B2B medical device companies with lean internal teams Manufacturers preparing documentation for distributors, importers or regulatory partners Companies that need multilingual IFUs, labels, product pages or technical documentation Manufacturers looking for relevant EU distributors, importers or commercial partners Teams that want one controlled process instead of scattered freelance translations and ad-hoc outreach Companies that need to turn EU readiness into actual conversations with the right market-entry contacts

Marcel Nijenhuis Founder of 9hows

Founder

Founder-led, with real B2B export experience.

9hows MedDev is led by Marcel Nijenhuis, founder of 9hows. Marcel combines 20+ years in professional translation with earlier commercial experience in technical B2B markets, export, distribution and manufacturer-led growth.

For medical device manufacturers, that combination matters. EU market access is not just about translating documents. Documentation needs to be linguistically accurate, technically consistent and commercially usable — so the manufacturer can move from preparation to serious conversations with distributors, importers and partners.

Team

A specialist network for language, documentation and market entry.

9hows MedDev works with a focused team of translators, reviewers, researchers and project coordinators. For medical device projects, the workflow is built around controlled terminology, clear versioning, review coordination, market research and practical commercial follow-up.

Marcel

Founder / strategy / client lead

Vika

Operations and project coordination

Specialist translators

Medical and technical translation

Local reviewers

Language-market review support

Research support

EU market, distributor and importer mapping

Outreach support

Contact preparation and follow-up support

Offers

Focused ways to prepare and open EU market conversations.

Starting point

EU Market Access Readiness Scan

A focused review of your current documentation, translation status and commercial market-entry materials. We identify language, terminology, consistency and market-readiness issues that could create friction when preparing for EU markets.

Deliverables

Documentation inventory
Terminology and consistency notes
Translation/review risk overview
Market-facing materials review
EU commercial readiness notes
Practical action list

Documentation layer

MDR-aware Translation & Review Workflow

A controlled translation and review process for IFUs, labels, packaging text, product information, manuals and related technical documentation.

Deliverables

Translation workflow
Terminology management
Reviewer comments workflow
Version control support
Final clean files
Documentation handover for commercial use

Flagship

90-Day EU Market Access Sprint

A 90-day sprint to prepare both the documentation layer and the commercial access layer for EU expansion.

Deliverables

Documentation intake
Translation and terminology plan
Priority document translation/review
Distributor-facing product materials
EU distributor/importer mapping
Target contact list
Outreach messaging
Qualified conversation support
Final handover pack

Commercial access

EU Distributor & Importer Outreach

For manufacturers whose core documentation is already in place, we help identify and approach relevant EU distributors, importers, specialist resellers and commercial partners.

Deliverables

Target market selection
Distributor/importer research
Contact list building
Outreach copy
LinkedIn/email approach
Conversation tracking
Follow-up support

Scope depends on device type, document volume, available source materials, target markets, existing regulatory setup and the manufacturer's commercial readiness.

9hows MedDev does not act as a Notified Body, legal adviser, PRRC or regulatory authority. We support manufacturers with documentation, translation, terminology, review coordination, market-facing materials, distributor mapping and commercial outreach for EU market access. Regulatory and legal responsibility remains with the manufacturer and its appointed regulatory partners.

Discuss your EU market access sprint

Latest notes

Short notes on documentation, language and EU access.

Why medical device translation is part of market access, not just localization

In medical devices, translated documentation needs to support regulatory, technical and commercial use — not just sound natural in another language.

Why EU distributors need more than a product brochure

Serious distributors need clear product information, documentation status, market context and a credible reason to start the conversation.

How inconsistent terminology creates EU documentation friction

Small terminology differences across IFUs, labels, product pages and sales materials can create confusion, review comments and avoidable rework.

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Preparing a medical device for EU markets?

If your documentation, translations and market-facing materials need to become more controlled — and you want to open the right commercial conversations in Europe — let's talk.

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Based in the Netherlands. Working with medical device manufacturers preparing for EU market access.