In Vitro Diagnostic (IVD) New IVDR CE Marking Workshop
The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes. The workshop aimed to 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.
This seminar provided insights into the key regulatory changes of the IVDR, to help prepare organisations and their devices for IVDR compliance.