Are You Ready for the In Vitro Diagnostic Medical Device Regulation (IVDR)?
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 cannot further be placed on 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.
Exploring the Relationship Between the IVDR and the IVDD
Use this tool to clarify the corresponding relationships between the general safety and performance requirements defined in the IVDR and the IVDD.
Your Free EU IVD Regulation Readiness Health Check
Take our “health check” to assess your EU regulation readiness, the first step for putting things in order.
The GSPRs (General Safety and Performance Requirements) The Heart of the EU IVDR
This whitepaper 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.
Articles and Brochures
Clinical Evidence for Medical Devices and IVDs: A Comparison of Requirements in Brazil and the EU
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.
In Vitro Diagnostic Services
Learn more about NSF’s IVD services including consulting, auditing and training throughout the product lifecycle.