On 25 June, the European Commission published an updated list of the European harmonized standards that pertain to the In Vitro Diagnostics Directive (98/79/EC). The standards on this list may be used by in vitro diagnostic device manufacturers to prove that their equipment complies with the essential requirements of this directive.
This updated list is important to all manufacturers of CE marked medical devices 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 our Library shortly.