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Medical Device Registration in EU
TECOLAB guide you through every step of registering your medical device in EU
The European Medical Device Regulation (EU MDR 2017/745) governs the safety, performance, and compliance of medical devices in the EU, replacing the previous directive (93/42/EEC).
Our Regulatory Affairs team provides end-to-end support for EU MDR registration, ensuring your products meet classification, technical documentation, and conformity assessment requirements, and assisting you throughout audits until certification is achieved.
Below are the key steps for medical device registration in EU.
Step 1 : Plan & Prepare For Compliance
I. Understand Your Product & Needs
We begin by discussing your organization, product, intended use, and EU market objectives. This allows us to create a tailored regulatory strategy that fits your product and business goals.
II. Classification, Documentation & Regulatory Setup
We identify the correct device classification and regulatory route to ensure your product follows the appropriate EU MDR compliance pathway. Our team reviews your existing documentation, performs a detailed gap analysis, completes the General Safety and Performance Requirements (GSPR) checklist, and prepares any missing documents.
We also assist with UDI assignment, EUDAMED registration, and coordination with an EU Authorized Representative, where required.
Step 2 : Ensure Quality & Achieve Certification
I. Quality Management System & Technical Documentation
We support the establishment and alignment of your Quality Management System (QMS) to meet EU MDR and ISO 13485 requirements. Technical documentation is prepared, structured, and reviewed to meet EU MDR standards and Notified Body expectations.
Click here to learn more about the technical documentation.
II. Notified Body Application & Audit Support
We coordinate directly with the selected Notified Body, manage technical documentation submissions, and guide you through the audit process. Our team provides support in addressing any findings to ensure a smooth and successful conformity assessment.
Step 3 : Get Your Medical Device to Market
I. CE Marking & Market Placement
Following a successful conformity assessment and audit, we assist with preparing the EU Declaration of Conformity and affixing the CE mark. This enables legal placement of your medical device on the EU market with confidence.
Step 4 : Ongoing Regulatory Compliance & Support
I. Maintaining Regulatory Conformity
After market approval, we provide ongoing regulatory support to ensure your device remains compliant throughout its lifecycle. This includes post-market surveillance, clinical evaluation updates, technical documentation maintenance, and preparation for surveillance audits, helping you stay fully aligned with evolving regulatory requirements.