Medical devices and IVDs: List European harmonised standards updated

The European Commission has published an update of the list of European harmonised standards under the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostics Directive 98/79/EC.

The standards on these list may be used by medical devices manufacturers to prove that their equipment complies with the essential requirements of this directive.

Announcement of the new lists of European harmonised standards in the Official Journal

These updated lists of European harmonised standards are important to all manufacturers of CE marked medical devices or in vitro diagnostics that have used European harmonized standards to prove CE compliance.

If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

The updated list of standards can be found in here, as well as in our Library shortly.

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