DIN EN ISO 13485:2016

On 15th of January 2018 DAkkS announced the end of the transition period for DIN EN ISO 13485:2016 for 31th of March 2019. It refers to the information for EN ISO 13485:2016 given in the list of harmonized standards under Directive 93/42/EEC for medical devices, which was published in the Official Journal of the European Union on 17th of November 2017. The European Standards Commission has set the withdrawal of EN ISO 13485:2012 to 31th of March 2019 and thus defined the entry into force of EN ISO 13485:2016.

This means that all certificates must be converted to EN ISO 13485:2016 by this date. Certificates that have not been converted lose their validity.

The new revision of the standard includes a number of changes that bring it closer to the American 21 CFR820 (Quality System Regulation) standard. Requirements of the Notified Bodies out of the NBOG and MEDDEV documents have been implemented now. The standard can now also be used by companies operating as service provider or supplier for the medical technology industry.

Up to now, EN ISO 9001 and EN ISO 13485 were very similar in their structure. Due to the new "high level structure" of EN ISO 9001, which has been defined by ISO/IEC for management standards, the two standards now differ, because EN ISO 13485 remains unchanged from the previous structure, a few exceptions excluded.

Valicare GmbH experts offers comprehensive service for the conversion to the EN ISO 13485:2016.

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