Is the IVD Industry Truly Ready for the IVDR DoA?
April 25, 2022
Any IVD medical device not complying with In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 by the date of application on May 26, 2022, or following the transitional provisions in Article 110 of the IVDR can no longer be placed on the EU market.
Among the huge regulatory changes from the IVD Directive 98/79/EC (IVDD) to the IVD Regulation 2017/746 (IVDR), manufacturers that could previously self-declare conformity (as many as 80%) now require a conformity assessment by a notified body. The IVDR has also placed a greater responsibility on manufacturers as well as an increased demand on designated notified bodies.
If you haven’t fully prepared for the IVDR, you must act now!
As the date of application of the IVDR draws closer, many manufacturers are struggling with the minefield of preparing technical files. To help assess your stage of the journey, consider these questions:
We can support you with training, consulting, preparation of technical files, technical file remediation, performance evaluation reports and more.
Check out our handy resources to get started.
Listen to Sarah Moore, Director of Medical Device and IVD Consulting, for practical advice on what the DoA means for manufacturers new to the IVDR.
Listen to Dr. Peter Wirthschaft, Senior Manager for IVD Consulting, EMEA, for practical advice that goes beyond the basics.
MedTech Summit and NSF conducted a huge survey of medical device and IVD professionals to discover the industry’s readiness for the IVDR.
Take our “health check” to assess your EU regulation readiness, the first step for putting things in order.
This white paper compares the essential requirements (ERs) described in the EU IVD Directive with the general safety and performance requirements described in the new EU IVD regulation.
Read our article by NSF experts Magdalena Brendel Rizzo, Senior Manager, Global Medical Devices, LATAM, and Kivia Pontes de Oliveira, Senior Consultant, Global Medical Devices, EMEA, published in the Journal of Medical Device Regulation.
Learn more about NSF’s IVD services, including consulting, auditing and training throughout the product lifecycle.
Find out about performance evaluation and post-market requirements.
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