EU MDR/IVDR Update: Revised MDCG 2019-13 Sampling Guidance

The European Union has released an update to MDCG 2019-13 rev.1, the guidance document for the sampling of Class IIa and IIb devices under the MDR and Class B and C devices under the IVDR. This revision outlines the requirements for sampling plans, the scope of technical documentation assessment, and the responsibilities of notified bodies.

Key Updates

• • Sampling Requirements: The guidance provides detailed criteria for creating and maintaining a sampling plan for technical documentation.
  • Reduction in Sampling: Previously, Footnote 10 allowed for a reduction of the sampling requirement from 15% to 5% only during the first certification cycle under MDR/IVDR.
  • Extended Reduction: With the latest update, the decrease to 5% can now apply until the next revision of the guidance.

Footnote 10 Update

The revised footnote states:

“The 15% may be decreased to a minimum of 5% until the overall ongoing revision of this guidance document will be published.

This change provides greater flexibility for notified bodies in sampling requirements during technical documentation assessments.

Access the Guidance

For more details, refer to the updated guidance document: MDCG 2019-13 Guidance on Sampling of MDR/IVDR

This update aims to streamline the certification process while ensuring continued compliance with MDR and IVDR regulations.

For guidance on navigating evolving regulations, contact us today.