Technical files

English > Health sector

In this frame we can distinguish between
a) Medicines sector where the activity of national bodies is co-ordinated at the European level by EMEA (European Medicines Agency).
b) Medical devices sector, where 2 different documents have been published:
- Directive 93/42/EC (with 2007/47/EC updates) Medical Devices
- Directive 98/79/EC In-vitro diagnostics
addressed in this web page.

These Directives identify conditions to place on the market a large and articulated range of medical devices, using the same approach developed for market harmonization in EU.

Wherever possible, also for medical devices EU delegates large responsibilities to the companies: however:
- The broad range of possible applications underlines the importance of product classification
- Application can often be critical, so it is more frequent the need to ask for Notified Body intervention
- Evaluating its specific situation, the company can choose different approaches (the so called modules) to show conformity to essential requirements.

Also in this case the company must prepare a Technical File which, besides product documentation, includes clinical studies aimed at confirming the effectiveness of the device and the absence of significant counter-indications.

This approach is reflected in a specific method for risk analysis according to EN 14971 standard, where risk management is based on the ALARP criterion (As Low As Reasonably Practicable).