The success of a MedTech business relies on the safety and patient care value of its products. So why do we need Medical Device Regulation (MDR) and what does the reinforced MDR in 2024 mean to your company? How can you navigate your products towards compliance?
Today MedTech, short for medical technology, is an essential aspect of the healthcare industry, providing innovative medical devices and systems that enables new ways of diagnosis, treatment, enhancing the effectiveness of existing treatments and providing better patient care. However, the safety of care can never be compromised upon and must always be at the centre of focus when developing new MedTech devices.
With the new Medical Device Regulation (MDR) coming into play, product development must comply with new stronger requirements to ensure the safety and efficacy of medical devices.
Addressing unmet medical needs
Developing new and effective treatments are crucial to meet the challenges in the health care sector as our population grows older. We need to treat more people at lower cost and with higher precision.
MedTech can help healthcare providers optimize their processes and workflows.
This can lead to improved healthcare efficiency, reduced costs, and improved patient outcomes.
At the same time technology development is difficult and needs to be balanced with proper safeguards to ensure effectiveness of the treatment.
Why do we need MDR?
First, let us establish what MDR is and why it is of interest to all of us.
The EU Medical Device Regulation, effective since 2021, strengthens oversight of medical devices and their manufacturers across 27 EU Member States, replacing national regulations. The idea is to safeguard the health and well-being of the people using MedTech devices.
From May 2024 regulations tighten and new and existing MedTech products will not even be allowed on the European market without MDR compliance. This cancels the previous case where medical devices CE marked under MDD (Medical Device Directives) were allowed an exception.
MDR regulations require manufacturers to diligently demonstrate that their devices are safe and effective for patients, leading to more reliable and effective medical devices and ultimately improving patient outcomes.
Compliance saves lives
Standards set a common level of compliance that medical devices need to meet. The focus of the regulatory framework is to minimize the risk of human error, such as those that use sensors and algorithms to monitor patients’ vital signs and alert healthcare providers when necessary.
The regulation governs the whole medical device lifecycle from development, manufacturing, distribution, to marketing, and the use of the medical devices.
An important aspect is the redundancy aspect of the medical devices, ensuring that safeguards are in place to ensure that a single fault in the devices does not cause harm to the patient and can be safely managed while the patient is being treated.
MDR requires manufacturers to use clinical data and post-market surveillance to demonstrate the safety and performance of medical devices, leading to more reliable devices that are better suited to addressing unmet medical needs.
This approach can help to improve patient safety and ultimately save lives. The regulations exist to improve healthcare processes and patient care, and the MDR goal is to ensure the safety, efficacy, and quality of medical devices.
Why engage Svep Design Center for your product journey?
Partnering with a company that specializes in medical device development and has experience in navigating the regulatory landscape can be invaluable in bringing products to market. We can provide guidance and support throughout the product development process and help ensure compliance with regulatory requirements.
Svep Design Center specializes in product development, and we have over 45 years of experience developing software and electronics. We help MedTech companies through the entire product life cycle from specifying requirements to certification and production. We also provide systems for IoT device monitoring, cyber security, and software maintenance.
Svep is certified according to ISO 13485 and undergoes yearly audits to ensure that we use safe, effective and regulatory compliant development processes.
Our significant investments in people, processes and equipment are all aimed at being an innovative and efficient development partner that ensures that your innovative product is going to market as quickly as possible without sacrificing quality.
Together, we can ensure that your products not only meet regulatory standards but also exceed customer expectations. Let’s embark on this journey towards safer, more compliant, and more successful products that have a true positive impact in the world.
Key insights to consider
MDR exist to improve healthcare efficiency.
For example, the use of telemedicine technology allows healthcare providers to deliver care remotely, reducing the need for in-person visits and improving access to care for patients who may not have easy access to healthcare facilities.
Similarly, medical devices that automate routine tasks, such as blood glucose monitors and insulin pumps, can help patients manage their conditions more effectively, reducing the need for frequent hospital visits and improving their quality of life.
And MDR compliance is crucial for enhancing patient safety, by requiring MedTech products to create medical devices that are safe and effective for patients. Medical devices must undergo rigorous testing and evaluation to ensure their safety, efficacy, and compliance with regulatory standards to create medical devices that are safe and effective for patients.
Your journey to product safety and compliance could begin with Svep.
Let’s collaborate to ensure your products not only meet regulatory requirements but also stay ahead in an ever-changing market.
We’re here to support your mission for secure and compliant solution or device, backed by decades of experience and a commitment to innovation.