+41 32 513 6767 | This email address is being protected from spambots. You need JavaScript enabled to view it.

Select your language

The presumed burden of post-market clinical data

65
As everyone is now aware, post-market clinical evidence for medical devices sold in Europe must be regularly collected and assessed. The EU Medical Device Regulation 2017/745 (MDR) demands an increased level of scrutiny of medical devices by notified bodies to guarantee their safety and...
Read More...

Intended purpose: The compass of your market strategy

127
When bringing a medical device to the market, the definition of its intended purpose is paramount. But what makes this intended purpose, also known as intended use, so vital for your business? Just as a compass helps travellers find their way, the intended purpose of a medical device directs...
Read More...

Clinical evaluation routes with limited clinical evidence

167
The Medical Device Regulation (MDR) has heightened the standards for clinical evidence, yet ambiguities persist regarding specific requirements. This article delves into the clinical evaluation routes outlined by the MDR, focusing on scenarios where limited clinical evidence suffices for...
Read More...

When does software qualify as a medical device?

297
With fast-developing technologies, software products have become essential to the healthcare industry. While the technical development of innovative software may be relatively quick, gaining market access for a software product within the scope of medical device regulations is no walk in the park....
Read More...

Summary of Safety and Clinical Performance: Plain language and health literacy principles

331
Creation of the Summary of Safety and Clinical Performance (SSCP) is a new requirement under the Medical Device Regulation 2017/745 (MDR) for implantable and class III devices. It is a publicly available and objective summary of the clinical evaluation, tailored to address the intended users and...
Read More...

The importance of clinical evaluation planning

540
With the introduction of the Medical Device Regulation 2017/745 (MDR), the regulatory requirements for the clinical documentation of medical devices have become more challenging. Uncertainties persist about how to precisely follow the newly introduced rules, worsened by variations in how different...
Read More...