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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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:
- EU MDR Article 2 Definitions - https://advisera.com/13485academy/mdr/definitions/ - see point 3)
- EU MDR Article 10 General obligations of the manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/ - see point 9)
- EU MDR Article 8 Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
- EU MDR Article 52 Conformity assessment procedures - https://advisera.com/13485academy/mdr/conformity-assessment-procedures/ - see point 8)
- EU MDR Annex XIII Procedure for custom made device - https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/
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:
- What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/
For more information regarding ISO 13485 please see the following links:
- What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
- Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
- Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Jul 29, 2020