In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR)

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.

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In Vitro Diagnostic Regulation (IVDR)
In Vitro Diagnostic Regulation (IVDR)
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IVDR In Vitro Diagnostic Regulation

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. The expertise of our IVD team means we are able to review devices covering over 80 NBOG codes. Our IVD specialists are product experts in their respective fields and have undergone rigorous regulatory training.








Dedicated training courses

Dedicated training courses

At BSI we offer training courses tailored to the In Vitro Diagnostic Regulation to help support and grow your business.



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