SEHTA, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU MDR Medical Device CE Marking Workshop.
THIS EVENT IS NOW FULL.
Why attend
To sell a medical device in the UK and Europe it must have the CE mark. This process is currently in transition. The new EU Medical Device Regulation (MDR) is in its implementation phase and will be fully effective from May 2020. All medical devices will need to comply with this new legislation. Companies are starting to make the transition and new technologies are going to need to comply with the new regulations.
This one-day interactive event will provide an overview of:
MDR CE Marking Process and the role of a Notified Body and Competent Authority
MDR Device Classification
MDR Conformity Assessment routes for class I, IIa, IIb and III products
Compiling Technical Files, Clinical Evaluation Reports & the Declaration of Conformity
Eudamed, Labelling and Language translation
MDR Post Market Surveillance & Vigilance
Outcomes
Gain an overview of the new EU Medical Device CE Marking Process
Understand the key areas of compliance required
Understand the technical documentation that should be in place for each device
An opportunity to discuss next steps, action plans and areas requiring clarification
Target Companies:
Medical Device companies and Pharma companies with combination products.
Target Market:
C-suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful, but particularly helpful for smaller, resource constrained organisations
To view the programme or to register please click here.