Is ISO 13485 certification required?
The author is often asked by medical device start-ups and others to provide support consultation for ISO 13485 certification.
However, ISO 13485 certification is not necessarily required.
In the case of Japan, it is sufficient if the QMS is established and operated in compliance with the QMS Ministerial Ordinance, while in the case of the U.S., it is sufficient if the QMS is established and operated in compliance with 21 CFR Part 820 QSR, etc.
And in fact, ISO 13485 certification is not mandatory in Europe either.
This is because the European CE marking system is self-declaratory.
It is sufficient to self-declare in a Declaration of Conformity that the design and manufacture of medical devices is carried out in compliance with ISO 13485.
Harmonized standards in MDR (European Medical Device Regulation)
As of January 4, 2022, nine new 9 standards were recognized as harmonized European standards. The standards include biological evaluation, sterilization, and aseptic processing of medical devices, quality management systems, use of symbols in product information These are standards such as.
This brings the total number of harmonized standards certified under the European MDR to 14 at this time.
This means that EN ISO 13485:2016 is finally MDR harmonized standard.
Benefits of complying with harmonized standards
The meaning of conforming to harmonized standards is as follows
In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been The requirements of that Regulation are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.
(Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), which provides that equipment complying with the relevant harmonized standards or relevant parts thereof equipment, published in the Official Journal of the European Union, shall be presumed to comply with the requirements of that Regulation covered by those standards or parts thereof).
In other words, Compliance with harmonized standards presumes that the applicable requirements of the MDR is a benefit of complying with harmonized standards.
In Japan, ISO 13485 certification may reduce the on-site inspection at the time of application for an item, and there are advantages to obtaining ISO 13485 certification.
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