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EU MDR Medical Device CE Marking Workshop

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Hempsons

100 Wood Street

London

EC2V 7AN

United Kingdom

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SEHTA, Psephos Biomedica and Mosaic Surgical would like to invite you to attend our EU MDR Medical Device CE Marking Workshop on 20th March in London.

Costs to attend - You will be invoiced via SEHTA after registration

SEHTA Members - £240 + VAT per delegate

SEHTA non-members - £280 + VAT per delegate (it's free to join SEHTA)

The organisers reserve the right to decline registrations based on review. All applicants will be notified by email if they have been accepted for a place no later than Friday 15th March.

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 full agenda please click here

Venue kindly supported by

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Location

Hempsons

100 Wood Street

London

EC2V 7AN

United Kingdom

View Map

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