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Following same model by the health authorities or by ISO standards

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Guest user Created:   Jul 27, 2020 Last commented:   Jul 29, 2020

Following same model by the health authorities or by ISO standards

We are an aligner/invisible braces manufacturing company having our head office in *** and manufacturing unit in ***. We would like to expand our business to *** and *** where we would like to sell our products directly to consumers as explained below:

1- A patient will order impression kit and take his/her impression by his/herself and send it back to the company
2-Company then prepares a treatment plan with the help of dentists and orthodontists and send the plan back to the patient for approval.
3- After approval, company will manufacture aligners and send it to the patient.

The whole process is monitored by dentists/orthodontists.

The same model is being implemented in many countries worldwide, a few examples are ***, ***, ***, etc.

Our question is that are we legally allowed to follow the same model in *** and *** by the health authorities or by ISO standards.

Thank you!

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jul 29, 2020

What you have described here are custom made devices. Since these are defined as medical devices according to the MDR 2017/745 Article 2, all manufacturers of medical devices need to have implemented a quality management system as described in Article 10. The quality management system shall cover all parts and elements of a manufacturer’s organization dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of the European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have to implement this standard.

For more details about MDR, please see the following articles:

Here is the link to the List of the harmonized standard:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

To understand what harmonized standards are, please see the article on the following link:

For more information regarding ISO 13485 please see the following links:

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Jul 27, 2020

Jul 29, 2020