Are You Ready for the In Vitro Diagnostic Medical Device Regulation (IVDR)?

Make sure your IVD complies with the IVDR requirements so it can remain on the market.
Hourglass and calendar - In Vitro Diagnostic Medical Device Regulation (IVDR) | NSF

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:

  • Have you completed performance evaluations of all your devices?
  • Does your quality management system (QMS) comply with the additional IVDR requirements or only with ISO 13485?
  • Is your UDI system going to be in place before your first audit?
  • Does your risk management follow the requirements of the IVDR.
  • Is it too late for you to engage with a notified body?

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.



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European Commission Extends IVDR Transition Period

October 19, 2021

Huge news (and relief) for the IVD industry as the European Commission proposes an extension to transition timelines for the IVDR. With up to 80% of IVD manufacturers engaging with a notified body for the first time and only six designated so far, this extra grace period is a step in the right direction as we recover from the COVID-19 pandemic.

To ensure impartiality, use of NSF management systems consulting services or attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.