Getting started with the CE stamp on your medical device
TechMed workshop Series 1/6
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.
WHEN Thursday June 22nd, 16:00-20:00
WHERE Carre 3.022, Experimental Centre for Technical Medicine (ECTM), University of Twente, Enschede
Registration & Coffee
16:15 - 16:30
Welcome - Introduction
16:15 - 17:00
MDD – MDR: introduction & some main changes
17:00 - 17:30
CE marking: Role of Notified Body, Classes, Annex routes
17:30 - 18:00
Fill in your own Technical file & discussion
18:00 - 18:45
Food & discuss technical files
18:45 - 19:15
Quality Management: introduction, and overview
19:15 - 19:30
Draw your own process overview
19:30 - 19:45
TechMed Workshop Series
19:45 - 20:00
Questions & drinks
Register before June 15th, 12:00. We will welcome a maximum number of 50 participants, participation is free of charge.
This workshop is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. This one-year-course of workshops covers the most important, but also most challenging, topics required for the development and production of a safe, reliable and useful medical device. The workshops are organized for (future) entrepreneurs in the medical device industry, take place every 2 months on an afternoon and focus on one specific topic every session. It is possible to attend the complete course, but also separate workshops.
By sharing their knowledge and expertise in the workshops series the TechMed Proeftuin partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction. The TechMed Proeftuin receives funding from ERDF (European Regional Development Fund) of the European Union and the course can therefore be offered free of charge.
This workshop is powered by Holland Innovative and Panton and supported by the TechMed Proeftuin