Why do medical device manufacturersneed Clinical Data for their device?

In order to be able to successfully place their product on the market, device manufacturers are legally obliged to provide objective evidence for their device’s safety and performance. This evidence, unless duly justified, needs to originate from thoroughly designed and executed clinical activities (both pre- and post-market), whose main objective is to provide evidence, that the device in question performs as intended and as officially claimed by its manufacturer.

In Europe, the regulatory landscape has been recently a subject to considerable and dynamic changes associated with the ongoing implementation of the EU 2017/745 (MDR) and 2017/746 (IVDR) regulations for medical devices and in vitro diagnostics, respectively.

Both of these regulations, as compared to their predecessors, increase considerably the importance of collecting robust and good quality clinical data to the next level. Figure on the right shows the relative frequency of appearance of the specific terms in the corresponding regulatory documents.

medidee-clinical-differences-ivdr-mdr-ivdd-mdd

The typical “million dollar questions”, that Medidee consultants are confronted with on day to day basis by our customers are:

How to collect that specific type of data in the most efficient manner?

and

How do I know what level of clinical evidence is suitable for my product?

Medidee has in their arsenal not only relevant tools and competences to address the above questions (as well as many others), but most importantly, a long track record of supporting our clients in defining THE most adequate clinical strategy for successful bringing (or keeping) their product on the international market. In addition, thanks to solid engineering and clinical background, we are capable to support you already from early design concept stage, through design validation, including clinical investigations, to market authorization.

As such, our approach is always unique and tailored specifically to your product’s intended purpose, risk and the claims you wish to advance.