The Medical Devices Directives and their implementation into national law (medical device law and decrees) have been revised several times. They are the basis for the marketing of medical devices in Europe.
Products that do not carry the CE marking may be restricted, prohibited from sale or forced to withdraw from the European market. Manufacturers and authorized representatives or anyone responsible for placing products on the European market can be held personally liable for damages or injury.
The existing guidelines with respect to the Medical Devices Directives are permanently being updated and extended. Medical device manufacturers, designers and suppliers have to adjust to these new and changed rules and carry out all associated procedures in order to comply with all mandatory EU requirements.
Who is responsible for what? What are the administrative procedures? Is a Notified Body required? Is there a relation between CE Marking and ISO? Those and more questions will be handled in this seminar.
Date: Wednesday March 7th, 2012 - afternoon session
Location: Park-Inn by Radisson Hotel, Martelarenlaan 36, 3010 Leuven
|As of 14h00:||Welcome and registration|
|14h30:||Introduction by Leuven.Inc|
|Medical Devices: current law and upcoming modifications
- Definitions Medical Devices
- Changes 2010 Directives
- Manufacturer obligations
|15h45:||The Certification Process
- Contact with Notified Bodies
- Conformity Assessment procedure
- Technical documentation
- Medical Quality system - ISO
|17h45:||End of the seminar|
Bart Mersseman, Systems & Services Certification Medical Devices SGS Belgium
110 euro (excl. VAT): members of Leuven.Inc
Participation in our activities at -50% discount via KMO-portefeuille
Registrations before Wednesday February 29th, 2012, preferably via the online registration form (use the 'Register' button) or by email to firstname.lastname@example.org (including all contact and invoice details).
After registration you will receive a confirmation and route description. The registration fee is payable after receipt of invoice. Cancellation after subscription is not possible. However, replacement by a colleague is allowed.*
* As an (Associate) Company Member you can be replaced by a colleague. As an individual Member you can only be replaced by another Individual Member. When this is not possible, Leuven.Inc will charge an extra fee for the replacement by a non-member.