4.2.4 and 4.2.5

This means that you need to store records from the production, purchasing, and sales if it is a lifetime of your device. For example, if for one medical device lifetime is 5 years, then you need to store and keep records about that device (each lot) for the 5 years. If for another medical device, lifetime is 3 years, then you need to store it for three years. But, if the lifetime of your medical device is one year, you need to keep it for two years. 

We don’t keep any confidential health information. Can we take out 4.2.5 from our procedure? The organization shall define and implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements.

No, you can't. But you can add this sentence: Currently, we do not keep any confidential health information. But once we have them, we will implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements.

I wanted to thank you for answering my questions. I do have a few questions. Our company does not manufacture any medical devices but medical components to customers in the medical field. Our customers take our medical components and assemble them into their medical device. We have the ISO 9001:2015 certification and working on obtaining the ISO 13485:2016 certification. Our customers do not require us to have a certification for ISO 13485:2016 but we want to obtain it for any future customer requiring us to have this cert.

1. How would we know what regulation is applicable if they have never stated?
2. Can the toolkit ISO 13485:2016 be combined with the ISO 9001:2015?
3. We don’t have to report to the authorities if we have a customer complaint. How would we right this in our procedure or would we leave this alone? Would we use the form also and if so how would we use this?

1. How would we know what regulation is applicable if they have never stated?

If you are on the EU market, then each manufacturer of a medical device or its components must be in compliance with Harmonised or state of the art standards (Article 8 of the Medical device regulation MDR 2017/745).

Those standards you can find on the following links:

• Commission implementing decision (EU) 2020/437 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC – 25/03/2020
• Commission implementing decision (EU) 2021/610 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.129.01.0153.01.ENG – 14/04/2021
• Commission implementing decision (EU) 2021/1182 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.256.01.0100.01.ENG&toc=OJ%3AL%3A2021%3A256%3AFULL – 16/07/2021
• Commission implementing decision EU 2022/6 of 4th January 2022 - https://eur-lex.europa.eu/eli/dec_impl/2022/15/oj

Basically, besides ISO 13485:2016, all manufacturers must also be in compliance with ISO 14971:2019 (Risk management for medical devices),  EN ISO 15223-1:2021 (for symbols), and EN ISO 20417:2021 - Information to be supplied by the manufacturer. Is there any other technical standard it would depend on the type of components: is it metal, is it plastic, or something else.

For more information, see:

• EU MDR Article 8 - Use of Harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

2. Can the toolkit ISO 13485:2016 be combined with the ISO 9001:2015?

Yes, it can, several requirements are very similar like internal audit process, corrective actions management, non-conformity process, and document management. At the end of the standard ISO 13485:2016 you have Table B1 Correspondence between ISO 13485:2016 and ISO 9001:2015, and Table B2 Correspondence between ISO 9001:2015 and ISO 13485:2016, therefore from both sides.

3. We don’t have to report to the authorities if we have a customer complaint. How would we right this in our procedure or would we leave this alone? Would we use the form also and if so how would we use this?

This just depends on whether or not your product is registered somewhere as a medical device separately. If not, then you do not have to communicate with regulators.