Europe: Final Versions of Medical Device, IVD Regulations Published
EMERGO SUMMARY OF KEY POINTS
- Final versions of Europe’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published.
- The Regulations will enter into power following formal publication in April or May 2017.
- The text of the Regulations’ final versions appears little changed from their draft versions, but Emergo consultants have begun in-depth analysis of the documents to determine the extent and effects of any changes.
Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) (links open new web page where you can download PDFs of both regulations) have been published, and will come to a formal vote by the European Council on March 7, 2017 and by the European Parliament on March 20, 2017.
Following these votes, the MDR and IVDR are expected to be formally published in late April or early May. This means that the Regulations will enter into power in late May or early June of this year, as previously anticipated by Emergo consultants in The Hague.
Accordingly, the MDR will become applicable in three years (2020), while the IVDR will become applicable in five years (2022).
The MDR contains 123 articles over 566 pages, and the IVDR has 113 articles over 477 pages. Based on Emergo’s initial analysis, there are few changes between the final versions of the Regulations and their draft versions published in 2016. However, some of these changes may significantly impact certain medical devices or economic operators in Europe. Over the next few months, we will analyze the MDR and IVR in depth, and publish pertinent information for industry participants affected by these new Regulations.