Deadline for compliance with added MDR harmonized standards


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Thank you for your valuable advice.

I recently found that a harmonized standard for MDR has been added.
By when should we comply with these harmonized standards?
Note 1: Our medical devices are MDR compliant as Class 1.

Thank you for your kind answer in advance.


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Refer to harmonized standards for MDR has been added.
I do not believe ISO comments on transition timings. That is up to regulatory authorities in each country.

Thank you for your quick reply.

I found ”DECISION (EU) 2022/6”. (Sorry, I just registered recently so I can't seem to get the link yet.)
According to above source, harmonized standards such as EN ISO 13485: 2019 + A11: 2021, EN ISO10993 series, EN ISO15223, etc. have been added.

At this point, I realized that I should ask this question in the medical device category. That way you can find someone who wants to ask similar questions later. So I move this question to that category.

Thank you for your kind and quick answer.
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