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EU MDR Medical Device CE Marking Workshop

March 20 @ 10:30 pm

Venue

Hempsons, 100 Wood Street, London, EC2V 7AN
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Website:
https://www.sehta.co.uk/Post/mhealth-app-national-workshop

Organiser

SEHTA
Email:
Website:
https://sehta.co.uk
20
March

SEHTA, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU MDR Medical Device CE Marking Workshop.

Date: Wednesday 20 March 2019

Venue: Hempsons, 100 Wood Street, London EC2V 7AN

Times: 10:30 – 16:00

Costs to attend: – You will be invoiced separately after registration

SEHTA Members – £240+ VAT per delegate

SEHTA non-members – £280+ VAT per delegate (it’s free to join SEHTA – Please click here)

Venue kindly supported by 

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

Please note that places are limited & the organisers have the right to review all applications.  Confirmation will be sent by 15th March and invoices will be sent separately by SEHTA.

Please note that in compliance with our GPDR policy, by registering for this event, you are automatically added to our mailing list.  If you wish to unsubscribe email info@sehta.co.uk with your details.

Agenda

Times Programme
Speaker
10:30 – 10:45 Registration & Refreshments
10:45 – 10:55 Welcome Jacques Du Preez, MD, Mosaic Surgical & Neil Roberts, COO, SEHTA
10:55 – 11:35 CE Marking Overview Robin Stephens, CEO, Psephos Biomedica
11:35 – 12:15 Device Classification Jacques Du Preez
12:15 – 13:00 Networking Lunch
13:00 – 13:40 Conformity Assessment Route Robin Stephens
13:40 – 14:10 Tech Files, Clinical Evaluation Reports, Declaration of Conformity Jacques Du Preez
14:10 – 14:40 Labelling & Language Jacques Du Preez
14:40 – 15:00 Refreshment Break
15:00 – 15:30 Post Market Survelliance & Vigilence Robin Stephens
15:30 – 16:00 Roundtable discussion inc Q&A
16:00 Close

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