Leuven.Inc seminar 'CE Marking for Medical Devices' - PM

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.

Practical aspects

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
- Classifications
- Manufacturer obligations
15h30: Short break 
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

Participation fee

110 euro (excl. VAT): members of Leuven.Inc
150 euro (excl. VAT): all others


Participation in our activities at -50% discount via KMO-portefeuille
Pijler OPLEIDING: Leuven.Inc Approval number DV.O106761
More info:


Registrations before Wednesday February 29th, 2012, preferably via the online registration form (use the 'Register' button) or by email to admin@leuveninc.com (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.

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