The European Commission is revamping its medical device regulations to include the replacement of the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC with the new EU IVDR.
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 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.
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.
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