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  • Writer's pictureMoshe Yuval Shapiro

EN/ISO13485 – Quality Management Systems: What went Wrong? (Part I)

Updated: Oct 18, 2022

The EN/ISO1385: 2016 –Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes is the 4th edition of an evolving standard.

In many ways it is superior (requirements-wise) to the well-known ISO9001, especially due to the detailed requirements enforced medical-devices regulations.

But, there are several ambiguities that the editors of the current standard left embedded within it, and those should be fixed in order to improve the standard.

I would like to discuss several of those disambiguates and provide a solution to how to handle them.


Medical Device File
Medical Device File

Section 4.2.3 – Medical Device File of the standard provides details of how the organization should establish “For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.

The content of the file(s) shall include, but is not limited to:


a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use;

b) specifications for product;

c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;

d) procedures for measuring and monitoring;

e) as appropriate, requirements for installation;

f) as appropriate, procedures for servicing.”

On one hand those requirements reflect the needs for FDA’s Device Master Record (see 21CFR820.181), which introduces how the manufacturing of the product should be done. If that is the case any company that is not the “legal manufacturer” must have one for each medical device product it manufactures.

On the other hand, those requirements also resonate with the EU Technical File (see Annex II of the EU 2017/745), which are more detailed than a mere “production file” and that is for the Legal Manufacturer not sub-contractors.

Is this requirement just for the Legal Manufacturer or for all Manufacturers? How should we refer to non-tangible products (e.g. – software)?

The solution should be to rely on Section 0.2 of the standard that determines that “Regulatory Prevails.” As a result, the requirement should be separated into 2 requirements:

Requirement A: A requirement to establish a file that entails the know-how to manufacture/produce the product. This should be one of the Outputs of the Design, therefore part of Section 7.3.4 – Design Output or Section 7.3.8 - Design Transfer.

Requirement B: A requirement to establish, for each relevant market, a Medical Device File that entails the local marketing requirements. To my opinion this requirement should be part of Section 8.2.3 - Reporting to Regulatory Authorities

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