Article 16(4) Certification (MDR & IVDR)

Article 16(4) Certification (MDR & IVDR)

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BSI is designated to issue article 16(4) certificates for all types of medical devices and IVDs that are subject to activities laid down in Article 16(2)

Article 16(3) of MDR and IVDR establishes requirements for the quality management systems (QMS) that distributors and importers must implement when carrying out specific relabeling and repackaging activities for devices that have already been placed on the market. Article 16(4) mandates that these entities obtain certification from a Notified Body to verify that their QMS meets the regulatory requirements outlined in Article 16(3) and detailed in MDCG 2021-23.

MDCG 2021-23

For whom is Article 16(4) Certification relevant?

This certification applies to Importers and Distributors operating in the EEA who engage in the specific relabeling and repackaging activities described in Article 16(2).

The devices must already be placed on the market under the MDR or IVDR. Article 16(4) certification is not required for:

  • Operators subcontracted by manufacturers to perform relabelling or repackaging under the manufacturer’s control
  • Health institutions or hospitals that break up large device packs into smaller units for internal use
  • Legacy Devices under Directive Certification
MDCG 2021-26

Relabeling and repackaging activities

Some examples (See MDCG 2021-26).

  • Updating packaging labels.

  • Translating information provided by the manufacturer (e.g., IFU).

  • Adding additional information required to market the device in a specific EU Member State.

  • Repackaging devices without altering their original condition.

The certification process

Article 16(4) certification process follows the general conformity assessment as described in Annex VII of the MDR/IVDR.
  • Enquiry
  • Pre-application activities and quotation
  • Application review and contract
  • QMS audit and reporting
  • Final review and decision-making
  • Certificate issuance
  • QMS surveillance audit
  • Recertification audit
  • Certificate renewal

Note: Article 16(4) certification does not require technical documentation assessments or microbiology audits.