Antive webinar: Medical Device Regulation (MDR)

08 / 09 / 20

As a Med-Tech start-up, discover why scientific research plays an important role in CE marking and market access. The Antive partnership (consisting of the parties Isala – research manager – TAPAS – mi-ce – Factory CRO – CtrP) earns their spurs when it comes to clinical research with medical devices and guides MedTech startups.

In this webinar that they organize together with Health Valley, they will discuss the consequences of the Medical Device Regulation (MDR) for clinical scientific research. Following incidents in the past, eg with breast forms, metal-metal hips, pelvic floor mats, the EU has decided to tighten the rules on medical devices. Class 2b and 3 devices must go through a research process that is the same as that of medicines before a CE marking can be obtained. Products not marked with CE may not be used in humans more than only in research settings. These are complex processes in which the starting entrepreneur can use some help. The MDR sets similar requirements for decision support software and diagnostics.

In addition, they will discuss in this webinar the importance of thinking at an early stage about the correct data that must be collected in order to answer the research question or to speak to potential users (specialists in the hospital) for feedback about your product.

The event is open for medtech entrepreneurs and will be delivered in Dutch.

 

This workshop is powered by Briskr Validate! – a project funded by EFRO (European Fund for Regional Development)

Register via this link!

Antive webinar: Medical Device Regulation (MDR)

08 / 09 / 20

As a Med-Tech start-up, discover why scientific research plays an important role in CE marking and market access. The Antive partnership (consisting of the parties Isala – research manager – TAPAS – mi-ce – Factory CRO – CtrP) earns their spurs when it comes to clinical research with medical devices and guides MedTech startups.

In this webinar that they organize together with Health Valley, they will discuss the consequences of the Medical Device Regulation (MDR) for clinical scientific research. Following incidents in the past, eg with breast forms, metal-metal hips, pelvic floor mats, the EU has decided to tighten the rules on medical devices. Class 2b and 3 devices must go through a research process that is the same as that of medicines before a CE marking can be obtained. Products not marked with CE may not be used in humans more than only in research settings. These are complex processes in which the starting entrepreneur can use some help. The MDR sets similar requirements for decision support software and diagnostics.

In addition, they will discuss in this webinar the importance of thinking at an early stage about the correct data that must be collected in order to answer the research question or to speak to potential users (specialists in the hospital) for feedback about your product.

The event is open for medtech entrepreneurs and will be delivered in Dutch.

 

This workshop is powered by Briskr Validate! – a project funded by EFRO (European Fund for Regional Development)

Register via this link!

Event information

Date:
08, September, 2020
Time:
15:00 - 15:45
Where:
Online