Medical device manufacturers, are your devices compliant with the new standards?

Today, the European Commission published an update of the list of European harmonized standards for the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC), as well as the In Vitro Diagnostics Directive (98/79/EC).

These updated list are of importance to manufacturers of all types of medical devices that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, 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 our Library[i4w_onlyfor tagid=’162,164,179,183,295′]:
To access the Library please log in. Click here to read how to become member.

1 thought on “Medical device manufacturers, are your devices compliant with the new standards?”

  1. I would like to highlight point 3 of Article 12 which establishes the complete and maintained sterilization of medical devices as a primary requirement within directives (93/42/EC) and (93/42/EEC). Manufacturers will note that sterilization standards are subsequently stressed in supporting Articles as well. The weight which The Council of the European Communities places on medical device sterilization should signal to manufacturers that compliance with these standards is crucial, both from a business perspective and to ensure patient safety.

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