- 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 )
Since 2019, the EU Medical Device Regulation (MDR) has been positioned to replace the long-standing Medical Device Directive (MDD) of 2007, with full enforcement set for 2024. Surgivalley is fully prepared for this transition and has taken proactive steps to ensure compliance.Our dedicated MDR transition program, launched in June 2020, reflects our firm commitment to meeting the latest regulatory standards. Surgivalley is on track to secure MDR certification for all classes of medical devices within the coming year, safeguarding our strong market presence beyond 2024.As of June 2020, we have successfully aligned our Class I medical devices with MDR requirements, while the transition for Classes IIa and IIb is actively underway. Surgivalley remains committed to delivering excellence through compliance, innovation, and reliability.
Our company has effectively utilized the additional grace period to ensure a smooth transition. Following a successful audit by SGS Belgium, our ISO 13485 certification was recently renewed. By making the most of this extra time, we have thoroughly prepared our products to meet high standards of data integrity while also avoiding the costs typically linked to rushed implementations.
We are MDR-Ready at Surgi Valley
Surgivalley – Leading the Way in MDR Compliance for Class IIa Medical Devices
With the new Medical Device Regulation (MDR) coming into full effect in 2024, Surgivalley is fully prepared to meet and exceed these updated regulatory requirements. These changes significantly impact Class IIa medical devices, including invasive and electrical instruments, and Surgivalley is ready to ensure full MDR compliance without compromise.
As a reliable and ISO 13485 certified surgical instruments supplier, Surgivalley stands as your trusted partner in navigating the complexities of the evolving MDR landscape. Our advanced quality management systems are purpose-built to meet MDR standards and are supported by years of hands-on experience in manufacturing devices that conform to Annex II, III, and IV under 93/42/EEC.
Supplying high-quality surgical instruments to the global medical community has always been at the core of our mission. We are fully equipped to adapt to regulatory changes with precision and professionalism. Each product is expertly designed, developed, and manufactured with a strategic blend of technical expertise and regulatory insight, allowing us to deliver exceptional flexibility and performance in today’s competitive medical device market.
Even in challenging economic conditions, Surgivalley remains committed to working closely with healthcare partners worldwide—delivering innovative solutions that improve compliance, enhance product quality, and reduce operational costs.
SURGI VALLEY
Surgivalley is fully prepared for the upcoming changes affecting Class IIa medical devices. With the European Commission (EC) having announced in 2019 its plan to implement a Single Regulatory Document (SRD) for all Class IIa devices, the time has come to adapt to this evolving regulatory framework.
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Class
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Examples of Devices
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Description
|
Subclassifications
|
|---|---|---|---|
|
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.
|
Is (sterile condition), Im (measuring function), Ir (reusable surgical)
|
|
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
|
|
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
|
|
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
|
Since 2019, the Medical Device Directive (MDD), established in 2007, has been set to be replaced by the EU Medical Device Regulation (MDR), which will be fully implemented by 2024. Surgivalley is well-prepared for this transition. The company initiated its MDR transition program in Jun 2020 to ensure full compliance with the new regulations. Surgivalley is on track to achieve EMDR certification for all classes of medical devices within the next year, ensuring continued market presence beyond 2024. The company successfully complied with MDR requirements for Class I medical devices in Jun 2020, and the transition process is currently underway for Classes IIa and IIb.
