Article 16(3) of MDR & IVDR describe the requirements for Importers/Distributors who relabel and/or repackage medical devices in accordance with Article 16(2) and require an Article 16(4) Certificate from a Notified Body to market modified products in a relevant EEA Country. BSI Notified Body launched its Article 16(4) Certification Scheme on the September 25th.

This webinar will discuss Article 16 MDR/IVDR and BSI’s Article 16(4) Certification Scheme.

What will participants gain?

• Knowledge and understanding of Article 16.
• A better understanding about when an economic operator changing products is to be considered the manufacturer of a device and shall meet the obligations as specified in Art 10 of the Regulations (CE Marking).
• More about when and under what conditions can an importer / distributor implement changes and apply for an alternative conformity assessment route leading to Article 16(4) Certification.

Who should attend?

This insightful webinar will be beneficial to manufacturers, importers, distributors and authorized representatives.