GLOSSARY

EU IVDR

The European In Vitro Diagnostic Regular (EU IVDR) replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. This initiative aims to improve the clinical safety of in vitro diagnostic medical device regulations in the EU Market.

The European Commission is in the process of updating the decades-old MDD and IVDD upon deciding these directives did not adequately reflect the needs of today's medical device marketplace. Up until the release of the new legislative documents, medical device manufacturers have been expected to comply with the medical device directive that was most relevant to their device. The options were:

Medical Devices Directive (MDD) 93/42/EE
In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC
Active Implantable Medical Devices Directive (AIMD) 90/385/EEC

Under the new regulatory framework, two new regulations were published on the 5th of April 2017. The European MDR will go into effect on May 26th of 2020, while the EU IVDR will have a slightly longer transition, going into effect on May 26th, 2022.

The European Medical Device Regulation (EU MDR), known as Regulation (EU) 2017/745 repeals and replaces the MDD 93/42/EEC directive and the AIMD 90/385/EEC directive.

The European In Vitro Diagnostic Regulation (EU IVDR), known as Regulation (EU) 2017/746 repeals and replaces the IVDD 98/97/EC directive.

EU IVDR vs IVDD

EU IVDR was created as a replacement for EC's previous legislation, IVDD. EU IVDR provides stricter oversight by implementing a risk-based classification system that requires the oversight and supervision of a notified body. Only about 10-20% of IVD manufacturers needed a notified body's statement of conformity under IVDD; however, the percentage jumps to 80-90% under EU IVDR. IVDR has also expanded labeling requirements for increased traceability of devices and transparency and the integration of the unique device identifier (UDI). UDI information must be uploaded the European database for medical devices (EUDAMED).

Greenlight Guru Supports Quality and Compliance with EU IVDR

Whether your medical device company is entering the European marketplace for the first time or transitioning from compliance with IVDD to EU IVDR, you will be required to establish a quality management system that conforms to the ISO 13485 medical device quality standard.

Greenlight Guru's medical device QMS software simplifies the quality and regulatory burden for device companies to implement an ISO 13485-compliant quality system that streamlines the conformity assessment process with Notified Bodies. With purpose-built workflows for mutli-level design controls, risk management, and advanced document control management functionality, Greenlight Guru helps medical device manufacturers drive down compliance costs, speed through audits and get true quality products to market faster.