MDR Medical device documentation for distributors

According to the MDR 2017/745, Article 14, you as distributor need to prepare and check, the following the documentation for each medical device (or device family):

• CE certificate
• Declaration of conformity
• Instruction of use and labels are on the proper language

The distributor of medical devices needs to have implemented a quality management system (QMS) (in MDR there is no requirement for certification of the quality management system, only that QMS must be implemented). In ISO 13485:2016 in 1. section – Scope – is stated that this International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to prove that medical devices and related services meet customer and applicable regulatory requirements. Such an organization can be involved in one or more stages of the medical device life-cycle including design and development, production, storage and distribution, installation, or service.

Further on, in MDR (Article 1, section 2) is stated that all medical device needs to be in compliance with harmonized standards or state-of. the art standards. On the list of harmonized standards, only one standard that is considering the quality management system is ISO 13485:2016. Therefore, it is expected that distributors and importers will also have implemented a quality management system according to the applicable requirements from ISO 13485:2016.

Here is the link to harmonized standards: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

For more information, please read the following:

• EU MDR Article 1, section 2: https://advisera.com/13485academy/mdr/subject-matter-and-scope/
• Similarities and differences between ISO 9001:2015 and ISO 13485:2016: https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

Also, you can see what our ISO 13485:2016 documentation toolkit can offer for those documents that are different when compared to ISO 9001. You can purchase from this toolkit only documents that are missing in your QMS: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

Thanks Kristina for your thorough explanation, this is very useful for distributors seeking to meet MDR requirements.

As you have mentioned, the key areas for distributors are Core documentation (CE certificate, Declaration of Conformity, compliant IFU's and labelling) and the implementation of a Quality Management System. Many distributors have an ISO 9001 Quality Management System in place, and may think this is all that is necessary, however, unless an organisation has implemented and maintained their QMS in accordance with the ISO 13485:2016 Standard and have been issued a certification from a registration body then other requirements must be met in order to comply with the MDR.

Your comments regarding the expectation for compliance with ISO 13485:2016 through the application of the MDR as a harmonised standard and the differences between the ISO 13485:2016 and ISO 9001 Standards, will assist in creating a common understanding of the differences in requirements of the ISO 9001 Standard versus the ISO 13485:2016 Standard and the compliance requirements of medical devices here https://www.akstamping.com/medical

The phased approach for documentation and classification and submission of documentation and devices is an effective means of meeting MDR compliance.

Thank you for providing references and links to assist all distributors in their MDR preparedness.