European Union Approves New List of Harmonized Standards for Medical Devices

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. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side. Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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April 30, 2020