MDR
IVDR
Medical Device Regulation (MDR) - In Vitro Diagnostic Regulation (IVDR)
Medical Device Regulation (MDR)
In Vitro Diagnostic Regulation (IVDR)
 

MDR

Support for Your Medical Device Regulation (MDR) Compliance Transition 

In May 2017, the European Commission voted to approve new Medical Device Regulations (2017/745). This is one of the most significant updates to the regulations that govern medical devices in Europe’s recent history. MDR impacts all companies marketing devices in the EU that wish to continue doing so.

The transition to the new MDR can be overwhelming if you do not have the resources required to support it.
Get prepared.

  • Access a Key Dates to Remember for MDR timeline to help keep your organization on track
  • Read a case study detailing how a medical device manufacturer became compliant with company and industry requirements
  • Explore Oxford’s MDR process and find out how our experts can support your organization’s MDR compliance needs
 

IVDR

Support for Your In Vitro Diagnostic Regulation (IVDR) Compliance Transition

In May 2017, EU officials announced regulations impacting organizations that manufacture in vitro diagnostic devices in both Europe and the United States. In order to sell their products in the European market, organizations must complete compliance with these new regulations by May 2022.

While the deadline of May 2022 for complying with the In Vitro Diagnostic Regulations (IVDR) might seem far away, when you consider the challenges ahead it’s important to start taking steps now to prepare.

  • Access an infographic to guide you through the steps, the key dates to remember, and other insights on how to achieve IVDR compliance on schedule
  • Learn how a large pharmaceutical organization was able to achieve compliance and deliver 50 new combination products to market
  • Explore how Oxford’s IVDR staffing and consulting services are tailored to fit your organization’s needs