Regulatory Services

Article 16(4) Certification (MDR & IVDR)

Providing practical Notified Body perspective to enable a more streamlined certification pathway.

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 the MDR and IVDR sets out the requirements for the quality management systems (QMS) that distributors and importers must have in place. These requirements apply when they carry out specific relabelling 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 defined in Article 16(3) and further 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 relabelling 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

Relabelling 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.