All medical devices must be CE marked in order to be sold on the European market. The CE marking means that the products must meet special requirements. As there is now a shift in the legislation in the field of medical technology, which will take place during a transitional period, this text is focused on the new legislation that is gradually coming into force.
Process for CE marking
The CE marking process for medical devices is regulated by EU common legislation. From May 2021, the Medical Device Regulation (MDR) and from May 2022, the In Vitro Diagnostic Regulation (IVDR) is in place.
According to MDR medical devices are divided into four different risk classes: I, IIa, IIb and III. Depending on the product's risk classification, the processes for CE marking look different. For products with lower risk potential, the manufacturer must conduct the CE marking process on its own, while for the higher risk classes it is required that a third party, a notified body, makes an assessment of the product.
Companies must always issue a declaration of compliance with regulatory requirements for product safety for intended use and that the manufacturer has a system for monitoring how the products work in practical use.
Read more about the regulations for medical devices on the Swedish Medical Products Agency's website