While manufacturers of medical devices focus their efforts on developments and production of devices, sometimes the “medical” part may be overlooked.
In the medical device industry, we are surrounded by regulations, starting in the EU with the Medical Device Regulation, followed by international standards, and complemented by, for example, MDCG guidances that help with interpreting and implementing these requirements.
In some cases, these frameworks are viewed merely as a regulatory burden, something that slows down business and innovation. In fact, they are the distillation of decades of collective experience and knowledge of the industry. They exist for a reason: to ensure that medical devices are safe, effective, and beneficial for patients.
And that’s the key point that shouldn’t get lost – the ultimate focus of all these requirements is the patient.
We see companies focusing on implementing requirements without truly understanding them. This can lead to misinterpretation, inefficiency, and even non-compliance.
So here are a few simple but fundamental reminders for medical device manufacturers:
- Keep in mind that you are producing a medical device.
- Be crystal clear on what your product is, how it performs, and what its benefits are.
- Establish these fundamentals early in development and maintain them consistently throughout the product life cycle, unless a justified change is needed.
And, of course, none of this can be achieved without trained and qualified personnel. Since there is no formal education path dedicated to regulatory affairs in the medical device industry, it’s an ongoing challenge for manufacturers to find and retain experts, and to keep their knowledge up to date.
Still, one truth remains constant: keeping regulatory compliance in focus is the surest way to bring a product to market – and keep it there.
At Starodub, we aim to be your trusted partner, supporting you in achieving and maintaining regulatory compliance for your medical devices, so that you can focus on innovation and patient benefit.
