EU CE Compliance Class I

I have a Class I mobility aid ready for market release and now need full regulatory coverage so it can carry the CE mark and be legally sold across the European Union. The product details are public at www.myevomobility.com.

What I need is someone who already lives and breathes the EU Medical Device Regulation (2017/745). You will guide the entire conformity process, prepare all required documentation, and see the device through to successful registration. You may work alongside my in-house engineering team, but ownership of the compliance pathway will be yours.

Key items you will handle
• General Safety & Performance Requirements (Annex I) checklist and gap analysis
• Risk management file in line with ISO 14971
• Clinical evaluation report suited to a low-risk, Class I device
• Technical file compilation, including design dossiers, labelling, IFU and traceability evidence
• Preparation for EUDAMED device registration and, if relevant, Authorised Representative coordination
• Final Declaration of Conformity and guidance on affixing the CE mark

Acceptance criteria
• Technical file passes an independent regulatory review without major findings
• All documents supplied in editable English formats
• Clear timeline showing each milestone from kickoff to CE mark readiness

When you respond, focus on your direct experience with EU MDR Class I (or higher) devices and any recent successful CE markings you have delivered. A concise overview of that experience is all I need to shortlist you—no lengthy proposals required.

I’m ready to start as soon as we agree on scope and timeline.