What's the webinar about?

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 25 of September.

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

Who should attend?

This webinar is open to everyone but will be of most interest to manufacturers, importers, distributors, and other authorized representatives. 

What will participants gain?

Participants will gain knowledge and understanding of Article 16. 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). 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.

Speakers

Dr Albert
Roossien
Bert is a Regulatory Lead with BSI since 2017. He is co-responsible for the continued designation as a Medical Devices Notified Body. He is involved in maintaining BSI’s Quality Management System including its, procedures, forms and work instructions used during the Conformity Assessment and Certification Processes. He is also involved in the Competence Verifications, Qualification and Authorization of personnel involved in the activities. He has many years of experience as a Quality & Regulatory Manager in the Medical Devices Industry.

To find out more about Article 16(4) Certification Scheme, please visit our dedicated news page here.

Email: us.medicaldevices@bsigroup.com

Phone: +44 845 086 9000

 

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