The company, which is a distributor of medical devices but not an authorised representative, plans to purchase medical devices in various EU countries and supply them repackaged to other EU countries. The repackaging operations would be as follows: replace the outer packaging (box), stick a new label on the container and adding instructions for use. The package, sticker and instructions would be in the language of the country to which the medical device is to be supplied. The integrity of the inner container would not be compromised. Do I understand correctly that according to the requirements Article 16 of MDR, such a distributor would have to apply to a Notified Body to have its quality management system assessed by NB?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Considering the Quality management system, yes, it is required that this distributor has its own Quality Management System under ISO 13485.
Thank you for your reply. However, I am a bit confused by this document: MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. This guidance does not mention that ISO 13485 is mandatory for repackagers of medical devices. Would the ISO 13485 certificate be the mandatory document to be submitted to the competent authority referred in Article 16(4) of Regulation (EU) 2017/745?
ISO 13485 is not specifically mentioned anywhere in the MDR, but the term quality management system is extended. However, Article 8 states that "Devices that are in conformity with the relevant harmonized standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to conform with the requirements of this Regulation covered by those standards or parts thereof." In the list of harmonized standards published in the Official Journal of the European Union, the only standard related to the quality system is ISO 13485. That is why manufacturers and distributors are expected to have introduced ISO 13485.
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Apr 15, 2024