CE certification and IVDR
In 2022, the new European IVD regulation will come into effect, which will cause many changes for manufacturers of IVD devices. One of the major changes is that manufacturers are no longer allowed to perform CE 'self-certification' for many products. Diagnotix is already preparing for this change.
By means of a CE mark, a manufacturer indicates that all relevant European regulations have been followed in the production of, in this case, medical devices. For a large number of products, manufacturers are still allowed to declare this themselves. So when a manufacturer indicates, with a so-called EC declaration of conformity, that he has followed all the rules, he may place a CE mark on his product.
In itself, a CE mark, strictly speaking, offers no more guarantees than the word of the manufacturer itself. If it turns out that the manufacturer has not followed the rules as closely as he has stated, it can be dealt with afterwards, but the damage - certainly with medical devices - has already been caused.
That is why the EU has introduced new regulations, in which new risk classes have been drawn up with corresponding requirements for CE marking. For Diagnotix this not only means more stringent requirements for the technical files, but also that all products can only be CE certified by a Notified Body.
The new regulations will not come into effect until May 2022, but because the number of providers of medical devices is large compared to a small number of Notified Bodies, diagnotix wants to focus on the future. With that aim, we have now made contact with a renowned Notified Body and we are on track to keep all our current and future products fully CE certified well before the new regulations come into effect.