VDE has been supporting the medical device industry for many years. During this time, the challenges for all those involved have constantly increased.
It is not made easy for companies. They have to take high risks in order to be innovative. Regulations and bureaucracy hinder market success. In 2017, the new European regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) also came into force. This has worsened the situation, especially for small, medium-sized and young companies. The corona pandemic has further exacerbated the situation.
Instead of using new technologies to help patients, companies have to comply with a large number of legal requirements. However, it is not only the scope of regulatory requirements that is a burden. In many cases, the European legislator also leaves those involved in the process in the dark about what exactly has to be fulfilled and how. Even the recent postponement of the MDR by one year will not really change this.
The aim of VDE Medical Devices and Software is therefore to clear up the regulatory jungle and simplify the path from the product to the regulated market. To do so, we contribute our many years of first-hand experience of regulation, standards, norms, testing and certification.
Safe and useful medical devices must reach patients as quickly as possible. Take advantage of VDE’s expertise and bring your product safely and quickly to the market.