New lists of harmonized standards was published in the Official Journal of the EU on March 25, 2020.
The lists relate to the three Directives on medical devices:
Council Directive 93/42/EEC of June 14, 1993 concerning medical devices
Council Directive 90/385/EEC of June 20, 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices
It was developed based on the above-mentioned documents. The harmonized standards aim to protect the health of the general public and workers and to prevent risks associated with the design, manufacture, and packaging of medical devices.
Once the device complies with a harmonised standard it means that it conforms with the corresponding essential requirements set out in the European Union harmonisation legislation.
Every list contains the requirements to the product itself but to the QMS as well as validation and routine control of a sterilization process for medical devices. The most extensive list refers to the Directive 93/42/EEC and contains more than 250 standards.
The full lists for every Directive you can find via the links below:
The information has been prepared by the GMA Consult Group team.
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