VDE has been supporting the medical device industry for many years. During this time, the challenges for all involved have steadily increased.
Companies have a hard time. They have to take high risks to be innovative, because 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 and young companies. The Covid-19 pandemic has made the situation even more difficult.
Instead of being able to help patients with new technologies, companies have to comply with legal requirements to an ever greater extent. However, it is not just the volume of regulatory requirements that is a burden. In many cases, European legislators also leave stakeholders in the dark about what exactly needs to be met and how. Safe and useful medical devices should reach patients as quickly as possible, however. Patients also have a right to expect new medical technologies to find their way into medical care.
The aim must therefore be to clear the regulatory jungle as far as possible and simplify the path from the product to patient care. To achieve this, we rely above all on the expertise of manufacturers and users, who know best how to develop safe and effective medical devices.
The Experts Panel Regulatory Affairs brings this expertise together. It is a group of experts from manufacturers and users who work on issues related to the approval and certification of medical devices and software. The 5 main goals of the Experts Panel are:
- Develop a common understanding of requirements in laws, standards and guidelines
- Learn and optimize best practices from others
- Articulate and advocate common positions to notified bodies, regulators and funding agencies
- Share current technical information on regulatory affairs and review own expertise
- Develop safe and innovative medical devices and get them into patient care quickly
VDE coordinates the Experts Panel and contributes its first-hand experience on regulation, standards, testing and certification. Current topics and approaches to improvement derived from them include:
- current regulatory deficits
- deficits at notified bodies
- missing standards, guidelines or regulatory gaps
- interpretation of certain documents
- requirements for networked systems
We welcome active participants who would like to join the Experts Panel Regulatory Affairs. Please just send an email to email@example.com if you are interested.