Are you ready for the new EU IVDR regulations to go into effect on May 26th?
From 26th May 2022, IVDR will become applicable for all Economic Operator (EO) and non-EU-manufacturer placing their IVD in European market. Therefore, all stakeholders and economic operators (Manufacturers, Suppliers, Notified Bodies, Competent Authorities, Authorized Representatives, Importers, etc.) in the process shall be equally responsible to get the requirements implemented. Currently under the IVDD, most of the IVDs are self-certified (93%), and do not require the involvement of a Notified Body, but this will not be the scenario anymore. Performing a correct classification and supporting the intended claims with clinical evidence will be essential since IVDR is a risk-based approach. Establishing a robust quality management system (QMS) is a general obligation of a manufacturer under Article 10 of IVDR. Be alert to these vital changes.
We will focus on the quality and regulatory requirements and implementation tips for IVD Economic Operators (EO) and non-EU-manufacturers to continue to place their device in the
- New product classification
- Quality Management System being essential
- Obligations for importers and distributors
- Person Responsible for Regulatory Compliance (PPRC)
- Performance evaluation
- Expecting unannounced audits
- Requirements for ‘In-House Devices’