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 after the transition period ends on May 26, 2022.
Hourglass and calendar - In Vitro Diagnostic Medical Device Regulation (IVDR) | NSF International

Any IVD medical device not complying with In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 by the May 26, 2022 date of application or following the transitional provisions in Article 110 of the IVDR will need to be removed from the EU market.

Amongst huge regulatory changes from the IVD Directive 98/79/EC (IVDD) to the IVD Regulation 2017/746 (IVDR) manufacturers that could previously self-declare that a product was in conformity (as many as 80%) now must have assessment of conformity by a notified body. The IVDR has also placed a greater responsibility on manufacturers as well as an increased demand on designated notified bodies that have limited capacity.

If you haven’t fully prepared for the IVDR, you must act now!

New Report: EU IVDR State of the Industry 2021

As the IVDR date of application 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 amended your legal contracts with your economic operators to be compliant?
  • Have you completed your performance evaluations of all your devices? Have you considered scientific validity, analytical performance and clinical evidence?
  • Does your quality management system (QMS) comply with the many new requirements or only with ISO 13485?
  • Is your UDI-DI going to be in place before your first audit?
  • Does your risk management plan follow the requirements of ISO 14971?
  • Have you left it too late 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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