Technical Documentation Review & EU Submissions
Technical documentation can be referred to as a number of names—technical file, EU documentation, EU dossier, Product Information File, Product Information Packet and more.
In order your products to legally enter the EU Market and continue to circulate, you must have valid documentation which demonstrates that they are safe for the end-user and are reflective of the essential safety and health requirements as laid out in the relevant legislation.
Each manufacturer is responsible for creating their own technical documentation and in most—if not all cases—must provide a declaration of conformity thereby declaring compliance with the law.
Finding the time or expertise to create a fully compliant EU technical file among other competing projects and priorities can be a challenge for many small to medium-sized manufacturers.
Obelis can support you in creating such technical files from scratch.
EU Submissions & Technical Documentation Services
Our technical file and EU submission consultancy include:
- EU Technical File Compilation
- Technical File Review & Gap Analysis
- MDR/IVDR Technical File Gap Analysis
- Clinical Evaluation Report
- Product Information File
- Notified Body Selection & Negotiation
- EU Trademark Submission
- Free Sales Certificates
- GMDN/ EMDN Code Verification
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