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It’s Official: European Parliament Approves Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • The European Parliament has approved final versions of the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR).
  • Following official publication, the Regulations will enter into force by early June 2017.
  • Implementation timeframes for the MDR (2020) and IVDR (2022) are on track.

European Parliament approves MDR, IVDRThe European Parliament has officially voted to approve the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed.

According to MedTech Europe, the Parliament approved the Regulations on April 5, 2017. Formal publication of the MDR and IVDR in the Official Journal of the European Union is anticipated for early May 2017; 20 days from that publication, entry into force of the Regulations will occur, likely in early June 2017.

Following entry into force, the MDR will become applicable in Europe in 2020, while the IVDR will become applicable in 2022. Emergo consultants in the US and Europe continue to analyze the latest iteration of the Regulations, which were released in February 2017, to identify any major changes between the final and draft MDR and IVDR versions.

Additional European MDR and IVDR resources:

  • Texts of the Medical Device Regulations and In Vitro Diagnostic Regulations (links to downloadable PDFs)
  • Whitepaper: European MDR timelines and strategies
  • Whitepaper: Understanding Europe’s IVDR
  • Webinar: Europe’s MDR

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