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I will get your medical device ce marked under eu mdr compliance
Tom W
About this gig
Getting a medical device to market in the EU means navigating the MDR (Regulation 2017/745) and mistakes here don't just cost money, they can stall your launch for months or trigger a Notified Body rejection.
I help medical device manufacturers and startups prepare accurate, audit-ready documentation for CE marking so your device meets EU requirements the first time.
What I handle for you:
- Device classification (Class I, IIa, IIb, III)
- Gap analysis against MDR requirements
- Technical Documentation (Annex II/III)
- Clinical Evaluation Report support
- Risk Management File (ISO 14971 alignment)
- Notified Body liaison for higher-risk classes
- Labeling and IFU (Instructions for Use) compliance
Why this matters:
Medical device compliance is unforgiving incomplete technical files are the #1 reason for delays. I make sure your documentation is structured the way assessors expect, reducing back-and-forth and getting you to market faster.
Message me with your device type and intended use before ordering, so I can confirm classification and scope accurately.
Get to know Tom W
Tom W
CE Marking EU Compliance Technical Documentation Specialist
- FromSpain
- Member sinceJul 2026
- Avg. response time1 hour
Languages
English
I help manufacturers, importers, startups, and Amazon sellers navigate CE marking and EU product compliance requirements. I assist with identifying applicable EU directives and harmonized standards, preparing Technical Files, drafting EU Declarations of Conformity (DoC), conducting compliance reviews, and advising on documentation needed before placing products on the EU market. My goal is to provide clear, accurate, and practical guidance that helps clients move toward regulatory compliance with confidence.
FAQ
Does CE marking apply to pharmaceuticals too?
No pharmaceuticals and medicines are regulated separately in the EU (via national health authorities or the EMA), not through CE marking. This gig covers medical devices specifically. If you're unsure which category your product falls into, message me
What device classes do you cover?
Class I, IIa, IIb, and III under EU MDR. Higher classes (IIb, III) require Notified Body involvement — I'll confirm your class before we start so pricing and timeline are accurate.
Do you provide clinical evidence or run clinical trials?
No I structure and prepare the Clinical Evaluation Report using existing clinical data, literature, or your trial results. I don't conduct trials or generate clinical data myself.
Can you guarantee Notified Body approval?
No one can guarantee approval that's the Notified Body's independent assessment. What I guarantee is that your documentation is complete, accurate, and structured to meet MDR requirements, minimizing the risk of rejection or delay.
What do you need from me to start?
Device description, intended use, risk class (if known), any existing test/clinical data, and manufacturing details. I'll send an intake form after you order.
Is this suitable for Class III / implantable devices?
Yes, but these require the most extensive documentation and Notified Body scrutiny. Message me before ordering so I can scope it properly, Class III work is priced individually beyond the standard packages.
