<ul><li>Medical device manufacturers must adhere to Regulation (EU) 2017/745 for MDR Medical device CE Marking to enter the EU market.</li><li>Notified Bodies conduct conformity assessments of Technical Documentation for CE Certification, ensuring compliance with Regulation requirements.</li><li>The Technical Documentation (TD) must be clear, organised, in PDF format, and include pre-clinical and clinical data as well as specific safety and performance aspects.</li><li>Consulting firms like I3CGLOBAL assist medium to small-scale enterprises in compiling Technical Documentation to meet requirements and secure a competitive edge in the market.</li></ul>

Technical Documentation is the essential Pathway to Medical Device CE Marking

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