Article 16(4) Certification Scheme

[Contenuto in lingua inglese]

As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to offer a new certification scheme for MDR and IVDR: Article 16(4) Certification.

What is Article 16(4) Certification?

Article 16(3) of MDR and IVDR introduces requirements related to the quality management system to be established by distributors and importers carrying out certain relabelling and repackaging activities (as described in Article 16(2)) of devices that have already been placed on the market. Article 16(4) of MDR and IVDR then requires that the distributors and importers who undertake these relabelling and repackaging activities get a certificate from a Notified Body to demonstrate that the quality management system established complies with the requirements specified in Article 16(3).

Relabelling and repackaging activities can range from:

• Updating a packaging label
• Providing translation of information already supplied by the manufacturer (e.g., instructions for use)
• Adding further information which is necessary to market the device in the relevant Member State
• Changes to the outer package of the device without affecting the original condition of the device, if the repackaging is necessary to market the device in the relevant Member State (e.g., change of pack size by breaking open a multi-pack box to distribute smaller numbers of the device to end users).

As a leading full scope Notified Body, 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).

For whom is Article 16(4) Certification relevant?

Importers and distributors based in EU, who undertake certain relabelling and repackaging activities as described in Article 16(2), for devices (irrespective of their classification) that are already placed on the market under the MDR, IVDR.

It should be noted that Article 16(4) certification is not required for the following entities:

• Operators (even if they qualify as an Importer or a distributor) subcontracted by the manufacturer of the devices, who carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.
• A health institution or hospital that splits up a large pack of devices, which they have received, into smaller pack sizes or individual units for use or circulation within the health institution/hospital.

Article 16(4) certification process with BSI

The conformity assessment process for Article 16(4) certification follows the general process as described in Annex VII of the MDR/IVDR. Importers/Distributors can apply with BSI through its Digital Pre-Application (DPA) Portal. Based on the application, a member of the commercial team will prepare a proposal (quotation included). A Scheme Manager will be assigned to you once the contract is signed and will be your referent throughout the conformity assessment and certification process as shown below:

* Article 16(4) certification does not require Technical Documentation assessments or microbiology audits.

Where can I find additional information?

If you need additional guidance on Article 16, refer to the Medical Device Coordination Group guidance MDCG 2021-23 for guidance on certification activities in accordance with Article 16(4) and MDCG 2021-26 for Q&A on repackaging & relabelling activities under Article 16.

We look forward to working with you in completing your Article 16(4) certification. To request a quote, click here.

Sincerely, Albert Roossien Regulatory Lead, Regulatory Services, BSI