regulatory requirements for submission of technical file for medical device in europe

Research Article
Patel Pooja, Krupa Thula* and Dilip Maheshwari
Medical Device, Technical File, Notified Body, Submission and documentation

Medical Device market is of greater value and having bigger scope of expansion in terms of money & utilization in upcoming years. No fixed format is prescribed for the technical documentation officially. Many entities have published guidance document on the topic of technical file content but any of the multiple formats is not sufficient. Two format guidance which worth reviewing were issued by Team Notified body NBMED and Global Harmonization Task Force (GHTF). Technical file may be considered as one document which is divided into different sections. Mostly Technical file and Design Dossiers are viewed as controlled documents. This article describes in detail about contents of Technical File Submission in Europe which are required for the marketing approval of medical device in Europe.