Once the transition period is over, all IVDs shall meet the requirements of the IVDR to be marketed in the European Union. However, to obtain the IVDR CE certificate it is necessary for the manufacturers and other operators involved, as appropriate, to possess a certified quality management system.
What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic Medical Devices?
The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are invited to act on time in order to be in compliance with the entry into force of the new Regulation. Among the most important innovations, we can mention: changes to devices classification (many IVDs [...]
The IVDR came into force in May 2017, but there are five years to adjust, until May 26, 2022. During the transition period, the Notified Bodies will be able to continue to issue the IVDD CE certificates, which will be valid for 5 years, provided that the date of application of the IVDR is not [...]
The manufacturer originally classifies its own devices. If the risk class established is the class I (lower risk), a Notified Body involvement is not required and the manufacturer can affix self-declared CE marking. While if class IIa or an higher one was established as risk class, the manufacturer will select and let intervene a Notified [...]
If a device manufacturer is established outside the European Union, it’s necessary to appoint an Authorized Representative by a written power of attorney. The Authorized Representative must be a physical or legal subject established in one of the EU countries, who represents the foreign manufacturer against the European competent Authorities. The Authorized Representative name and [...]
Medical Devices are classified according to their complexity and potential risk for the patient. In accordance with the current Regulation, four risk classes were established: I, IIa, IIb and III. The intended use the manufacturer established for the device, the device invasiveness, its energy source dependence and the time duration with the human body are [...]
The term Own Brand Labeling (OBL) refers to the particular procedure that a Medical Devices manufacturer should follow when marketing devices bearing a CE marking in its own name (“me too” device). The European Regulation considers the OBL manufacturer as the legal manufacturer even when he is not involved in the device manufacturing. Consequently, the [...]