- General Surgery Instruments
- Orthopedic & Spine
- Neurosurgical
- Electrosurgical
- Non-Stick Bipolar Forceps
- European Irrigation Bipolar Forceps
- Monopolar Cables
- USA 2 Pin Bipolar Forceps
- European Non-Stick Bipolar Forceps
- Bipolar Artery Sealer
- Diathermy Instruments
- Bipolar Electrodes
- Disposable Bipolar Forceps
- Electrodes 4.0mm
- Electrosurgical For Gynecology
- European Bipolar Forceps
- Gynecology
- ENT
- Cardiovascular
Medical Device Regulations ( MDR )
The Medical Device Regulation (MDR) defines the essential requirements that every device must fulfill before entering the market. So, these rules make sure that medical items are safe, effective and dependable while also protecting patients and healthcare workers. Moreover, MDR compliance is not limited to a single stage; instead, it extends across the entire product life cycle, covering design, manufacturing, clinical evaluation and post-market monitoring.
In addition, MDR introduces advanced identification and traceability systems that improve product tracking and increase transparency. Therefore, authorities and manufacturers can take immediate action if safety concerns arise. As a result, potential risks are addressed quickly and accountability remains stronger throughout the process.
For manufacturers, following MDR requirements is not only a legal responsibility. Rather, it represents a clear commitment to patient safety, product quality and continuous innovation. Furthermore, compliance helps build trust with healthcare providers as well as patients, reinforcing reliability in real clinical settings. Ultimately, adherence to MDR standards enhances global confidence in medical technology and contributes to better healthcare outcomes.
Our business used the additional time wisely to ensure a smooth transition to MDR compliance. We are proud that our team successfully renewed ISO 13485 accreditation after a detailed assessment by SGS Belgium.
This renewal strengthened our product readiness. Every device now meets the highest standards of quality, safety, and data integrity. In addition, careful planning helped us avoid the risks and costs often linked to rushing compliance. At the same time, we maintained a strong focus on innovation, efficiency and regulatory excellence. As a result, our medical devices continue to deliver long-term reliability and earn lasting trust.
We are MDR-Ready at Surgivalley
Surgivalley is committed to exceeding the new compliance standards of the Medical Device Regulation (MDR), enforced in 2024. These regulations introduce major changes for Class IIa devices, including electrical and invasive tools and our expert team is ready to meet them with precision and international expertise.
As an ISO 13485 certified manufacturer, we guide partners through the evolving MDR landscape with proven compliance to Annex II, III, and IV under 93/42/EEC. Our instruments meet strict MDR requirements because we design them with durability, safety and performance in mind. In addition, we integrate modern technology to improve adaptability, efficiency and reliability in global healthcare.
Even in challenging conditions, Surgivalley remains dedicated to supporting healthcare professionals. Moreover, our focus on innovation ensures trusted solutions that enhance product quality, streamline operations and strengthen long-term confidence across the global medical community.
SURGIVALLEY
Surgivalley is committed to exceeding the new compliance standards set by the Medical Device Regulation (MDR), fully enforced in 2024. These rules bring significant changes for Class IIa devices, including electrical and invasive tools and our expert team is prepared to meet them with precision and attention to detail. As an ISO 13485 certified manufacturer, we actively guide partners through the evolving MDR landscape and ensure strict compliance with Annex II, III, and IV under 93/42/EEC. In addition, our instruments meet international quality standards as we design them with durability, safety and performance. Moreover, we apply modern technology to enhance efficiency, adaptability and reliability in global healthcare markets. Even in challenging economic conditions, we remain dedicated to supporting healthcare professionals. As a result, our innovation and compliance-driven approach build trust, improve outcomes, and secure long-term confidence in our instruments.
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Class
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Examples of Devices
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Description
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Subclassifications
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|---|---|---|---|
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Class I
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Bandages, stethoscopes, eyeglasses
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Low-risk devices subject to general controls. Non-invasive with minimal risk to patients. Surgivalley ensures product identification and traceability through UDI Codes and ISO 15223-1 labels.
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Is – Sterile condition, Im – Measuring function, Ir – Reusable surgical
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Class IIA
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Hearing aids, catheters, short-term contact lenses
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Moderate-risk devices requiring higher regulation compared to Class I.
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N/A
|
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Class IIB
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Forceps, scissors, scalpels, ventilators, insulin pens, long-term contact lenses, incubators
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Higher-risk devices requiring rigorous assessment and conformity procedures
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N/A
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Class III
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Surgical mesh, replacement heart valves, breast implants, pacemakers
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Highest-risk devices subjected to the most stringent regulatory controls, including extensive clinical testing and evaluation.
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N/A
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Since 2019, the European Union has been transitioning from the 2007 Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). Because full enforcement begins in 2024, Surgivalley moved early to stay ahead of this important change.
Therefore, we launched our MDR compliance program in June 2020 to ensure a smooth and timely transition, and every step has been completed without delays. By June 2020, Surgivalley had already achieved MDR standards for Class I medical devices. Moreover, this milestone demonstrated our strong commitment to patient safety and regulatory compliance. In addition, work on certifying Class IIa and IIb devices is progressing with accuracy, consistency and careful planning. Consequently, with a clear strategy in place, Surgivalley remains on track to achieve MDR certification for all device classes within the next year.
As a result, this achievement guarantees uninterrupted access to international healthcare markets. Furthermore, it ensures our devices maintain the highest standards of safety and quality well beyond 2024. Above all, thanks to this proactive approach, Surgivalley continues to serve as a reliable partner in MDR compliance and a trusted leader in global medical device innovation.
