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EU MDR Medical Device CE Marking Workshop

This one day workshop was run by SEHTA and Psephos Biomedica on 20th March 2019


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 workshop provided 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 a Technical Files, Clinical Evaluation Reports & the Declaration of Conformity

  • Eudamed, Labelling and Language translation

  • MDR Post Market Surveillance & Vigilance

The outcomes:

  • Gain an overview of the new EU MDR 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

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