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)
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
- 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
Medical Device companies and Pharma companies with combination products.
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 firstname.lastname@example.org with your details.
|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|