What is the “period of grace” and how can I take advantage of it?
The "period of grace" is the time interval, which coincides with the due date, during which a CE certificate issued pursuant [...]
12 06 2019
12 06 2019
12 06 2019
12 06 2019
What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?
The "market surveillance" (performed by the Competent Authority) is the set of activities carried out and the measures taken to verify [...]
12 06 2019
12 06 2019
What are the MDR requirements for post-market surveillance, market surveillance and vigilance?
To monitor the traceability of Medical Devices throughout the supply chain, the European Regulations place not only more stringent requirements for [...]
12 06 2019
12 06 2019
What is the “post-market surveillance system”?
The post-market surveillance system (PMS) serves to “collect, record and actively and systematically analyze the relevant data on the quality, performance [...]
12 06 2019
12 06 2019
How can I continue to sell my devices after the full implementation of MDR?
The MDR certificate is a new certification and not an amendment of the Medical Device Directive (MDD) 93/42/EEC. However, pending the [...]
