Europe

Legislation

EU market (EC)

The marketing of medical devices in Europe is regulated by Directives 93/42/EEC and 2007/47/EC, while that of in-vitro diagnostic devices is regulated by 98/79/EEC.

These Directives require a process of "certification" from manufacturers more or even less complex in relation to the risk class of the medical device. Preparation of a technical file of the product is always required and, when necessary, also requires an audit in the company by a Notified Body to assess the design and manufacturing Quality System, before being issued a CE certificate.

Since the introduction of Directive 93/42/EEC ISEMED’s professionals, have always distinguished themselves as those who are first to have identified and adopted the simplest and most effective solutions to respond to the changes introduced by European Directives. We have lead the field on regulatory matters through countless consultation interventions, training courses for companies and certification bodies and participations as speakers to the major national conferences in the field of medical devices.

Directive 2007/47/EC, as from 21/3/2010, requires from medical devices manufacturers new duties to be performed prior to placing the product on the European market.

The main issues include:

• Clinical evaluation of medical devices (bibliographic or experimental)

• Software validation (when applicable)

We work with companies in:

• Creation of technical files for medical devices and in-vitro diagnostic

• Evaluation of preclinical medical devices

• Clinical evaluation of medical devices

• Validation of software for medical devices

• Validation of Special Processes and sterilization

• Implementation of company quality systems

• Registrations into Database of the Italian Ministry of Health

• Support for the Marketing of Medical Devices

• The EU Representative for Medical Devices