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Technical Files for the new EU Medical Device Regulations

This one day workshop was run by SEHTA and Psephos Biomedica on 12th June 2019


Summary:


The new EU Medical Device Regulation (MDR) is in its implementation phase and will be effective from May 2020. All medical devices will need to comply with this new legislation. Similarly, the IVD Regulation (IVDR) will be in force from May 2022. Many companies are not yet ready for the journey let alone have a roadmap of how to get to compliance.


This one-day event covered:

  • Provide you with an overview of the key requirements for technical documentation in order to comply with the MDR and your conformity assessment

  • Assist you in assessing your company’s current preparedness for the transition

  • Provide a clear, practical guide to the next steps that you and your company need to take to meet Technical documentation requirements to gain CE Marking under the MDR


Outcomes:

  • Gain an overview of the EU MDR Technical Documentation Requirements

  • Understand the technical documentation that should be in place for each device

  • Understand the key areas of compliance required

  • Gain a plan of action for implementation and CE Marking under the new legislation

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