23 April 2009 : 2008 Medical Device Workshop in Sao Paulo, Brazil

Published 23 Apr 2009

In reference to the expected changes in the European Directives, Obelis and EG Mont Assessoria e Consultoria Ltda. initiated a workshop in Sao Paulo, Brazil which focused on these changes and their implications.

There are two main changes that are particularly important.

1. A decreasing of the importance of the Medical Device Directive 93/42/EEC in respect to other European Directives
2. The influence of the MSD 98/37/EC and its amendment the 2006/42/EC on the MDD 93/42/EEC (with moving parts) and its amendment the 2007/47/EC, which will result in the combination of essential requirements in regards to both Directives

The transposition period for these changes:
• Begins December 21st, 2008
• Will be in full force March 21st, 2010

The workshop in Sao Paulo was entitled MARCAO CE PARA DISPOSITIVOS MEDICOS. The workshop focused on the new amendments to the MDD 93/42/EEC and AIMDD 90/385/EEC in reference to the 2007/47/EC and 2006/42/EC and presented a first guideline for the implementation of these amendments.

Details of the workshop as follows:
• Name: MARCAO CE PARA DISPOSITIVOS MEDICOS
• Subject: AS ALTERAES NAS DIRETIVAS DE DISPOSITIVOS MEDICOS
• Presenter: Senor Eduardo Gouveia Monteiro from EG Mont Assessoria e Consultoria Ltda.
• Date: June 12th, 2008
• Time: 8:30a.m. - 12:00noon
• Location: Av. Liberdade, 825 - Sao Paulo - SP Sao Paulo, Brasil
• Fee: R$ 150 (real)

You can find out more by e-mailing EG Mont at , or by phone at +55 16 3969 5154.

Back to Obelis News and Events