The Life Science Network for Wales

Events

Loading Events

In Vitro Diagnostic (IVD) New IVDR CE Marking Workshop

November 21 @ 10:30 am - 3:30 pm

Venue

Hempsons
40 Villers Street, London, WC2N 6NJ United Kingdom
+ Google Map

Organiser

SEHTA
Email:
Website:
https://sehta.co.uk
21
November

SEHTA and Psephos Biomedica are running their next workshop on IVD New IVDR CE Marking.

This seminar will provide you insights into the key regulatory changes of the IVDR, to help you to prepare your organisation and your devices for IVDR compliance.

Date:  Thursday 21st November 2019

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

Time:  10:30 – 15.30

Cost:  SEHTA members fee: £240 + VAT / Non-Members: £280 + VAT per delegate

Not a member of SEHTA?  It’s free to join – just click here

The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes.  Attendees will gain an understanding of:

  • The new IVD regulations (EU 2017/746), Device Classification and Key Time Lines
  • Significant differences between the current directive (98/79/EC) and the new IVD Regulations
  • The role and status of Notified Bodies
  • Outline of the Technical Documentation including Labelling and EUDAMED
  • Outline of the Quality System requirements
  • Outline of the Performance requirements/Clinical evidence
  • Outline of Post Market Surveillance requirements
  • Interact with fellow practitioners and presenter during the Q&A

The European Union’s Regulation on IVD medical devices 2017/746 (IVDR) came into force on 25 May 2017 and is currently in implementation. It will replace Directive 98/79/EC on IVD medical devices (IVDD) and there are only 2 ½ years left until the end of the transition.

Manufacturers of new IVD devices and devices currently approved under the current Directive will have to comply to IVDR from May 2022 onwards. This means they must comply with the new conformity assessment procedure for their device and quality system in order to CE-mark their devices and place them on the EU market. For products currently certified by a notified body – provided certain MDR requirements are met – the transition period may be extended until 26 May 2024.

New or stricter requirements of the IVDR will be challenging and have a significant impact on manufacturers and all other stakeholders. Changes affect areas such as classification of IVD devices, conformity assessment procedures, performance/clinical evidence, post market surveillance, labelling and registration.

The majority of devices will be reclassified and require Notified Body conformity assessment. For existing IVD manufacturers to meet the May 2022 deadline they will need to understand what is required and have a plan to address their current gap. For new manufacturers and devices understanding the new timelines, resourcing and expertise requirements will be crucial to success.

Not for: Pharma this is IVD Only.

 

Target Market:  Executives, product owners, medical officers, regulatory and quality specialists within a company that need to understand the overall requirements for their Invitro Diagnostic Devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful.

Agenda

Time Programme Speaker
10:30 -10:45 Registration & Refreshments  
10:45 – 10:55 Welcome & Introduction

 

Neil Roberts, COO, SEHTA
10:55 – 12:15 IVDR/ Classification/Notified Bodies/ IVD-IVDR differences Jacques Du Preez, Director

Psephos Biomedica

12:15 – 13:00 Networking Lunch Break  
13:00 – 14:15 Technical documents and Performance reporting/clinical evidence Jacques Du Preez, Director

Psephos Biomedica

14:15 – 14:35 Refreshment Break
14:35 –  15:20 Quality System Requirements / Post Market Surveillance/ FDA Jacques Du Preez, Director

Psephos Biomedica

15:20 – 15:30 Q&A All
15:30 Close Neil Roberts, COO, SEHTA

Places are limited so register today 

Please note – 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 8th November.

Partners:

Privacy Policy

Tel +44 (0) 2920 47 34 56 | The Maltings, E Tyndall St, Cardiff CF24 5EA. Copyright © MediWales 2019.
Web design & development by Teamworks