How will the IVDR 2017/746 affect the Quality System Management?
Once the transition period is over, all IVDs shall meet the requirements of the IVDR to be marketed in the European [...]
18 05 2018
18 05 2018
18 05 2018
18 05 2018
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 [...]
18 05 2018
18 05 2018
When will the IVDR 2017/746 enter into force?
The IVDR came into force in May 2017, but there are five years to adjust, until May 26, 2022. During the [...]
19 07 2017
19 07 2017
When is the Notified Body’s intervention needed?
The manufacturer originally classifies its own devices. If the risk class established is the class I (lower risk), a Notified Body [...]
19 07 2017
19 07 2017
When do I have to appoint an Authorized Representative?
If a device manufacturer is established outside the European Union, it’s necessary to appoint an Authorized Representative by a written power [...]
19 07 2017
19 07 2017
How can I establish a medical device risk class ?
Medical Devices are classified according to their complexity and potential risk for the patient. In accordance with the current Regulation, four [...]
18 07 2017
18 07 2017
What is the OBL contract?
The term Own Brand Labeling (OBL) refers to the particular procedure that a Medical Devices manufacturer should follow when marketing devices [...]
