13 March 2014 - 13:30 - De Montil, Affligem

Medical Devices session : new Belgian legislation and update on the revision of the medical devices directives

This conference aims to inform you on some recent developments at the European and Belgian levels regarding medical devices.

Lawyers from Simmons & Simmons LLP. will introduce this session by giving a short update on the Revision of the European Medical Devices Directives

One speaker from the FAMHP will then give an update on the Belgian Medical Devices Plan of the Minister of Health.

Speakers from the FAMHP and from UNAMEC will discuss (i) recent developments regarding traceability at the European and Belgian levels and (ii) recent developments regarding the vigilance system.

Lawyers from Simmons & Simmons LLP. will end the conference by discussing legal and practical challenges of classification.

Programme and Speakers:

13:30 Session introduction
Annabelle Bruyndonckx - BRAS Education Group

13:35 Update on the Revision of the Medical Devices Directives (English)
Annabelle Bruyndonckx/Olivier Mignolet – Simmons & Simmons LLP

13:55 Update on the Belgian Medical Devices Plan (English)
Augustin Coppée – AFMPS/FAGG

14:15 Traceability: developments at the European level (French)
Richard Van den Broeck - UNAMEC

14:35 Traceability: developments at the Belgian level (English)
Augustin Coppée – AFMPS/FAGG

14:55 Vigilance system: developments at the Belgian level (English)
Augustin Coppée – AFMPS/FAGG

15:15 Coffee break

15:45 Vigilance system: new proposals under discussions (Dutch)
Richard Van den Broeck - UNAMEC

16:05 The legal and practical challenges of classification: case studies (English)
Annabelle Bruyndonckx/Olivier Mignolet – Simmons & Simmons LLP

16:45 Questions & Answers

17:15 End of session
Marc Benijts - BRAS Education Group

Practical aspects: slides in English ; session in French (FR), Dutch (NL) and English (ENG)

Fees: BRAS member = 150€
           Non Member = 350€

Cancellation : In case of cancellation after 3 March 2014, the fees are due and will be invoiced.