In order to market a medical device within the European Economic Area (EEA), the product needs to bear the CE Marking.
This marking is a mandatory proof that:
- The device is safe; in accordance to the applicable legal norms & standards, as part of the MDD – MDR.
- The manufacturer is able to develop & produce products of high quality; in accordance to the required Quality Management standard.
Well begun is half done!
Getting the CE Marking is certainly not something you would do on a Friday afternoon but is often underestimated, especially now the regulations have been updated to the MDR.
You need a.o. to test the product; by official test houses on legal standards, build up a technical construction dossier, have a quality management system, with approved suppliers and implemented of risk assessments by proven competent team members. Most of these requirements however, could be prepared very early on during the development of a medical device, and makes the CE marking process later on much easier.
What: This training provides you with a starting point of what is changed due to the introduction of the Medical Device Regulation per 2017, what required for CE marking and Quality Management.
Subsequently an overview will be provided of other related topics covered in the TechMed Workshop Series: Remove the barriers to market readiness.
For whom: This knowledge is essential for everybody involved in or responsible for medical device development, both from a technology perspective as from a management perspective.
The TechMed Proeftuin is funded by the ERDF-program (European Regional Development Fund) and the workshop can therefore be offered free of charge.
Date: Thursday June 22nd
Location: Carre 3.022, Experimental Centre for Technical Medicine (ECTM), University of Twente, Enschede
Click here for more information
We are looking forward to meet you on June 22nd at the University of Twente!