- 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 set to replace the Medical Device Directive (MDD), which was established in 2007, with full implementation expected by 2024. Surgivalley is well-prepared for this transition. The company launched its MDR transition program in Jun 2020 to ensure full compliance with the new regulations. Surgivalley aims to achieve EMDR certification for all classes of medical devices within the next year, ensuring continued market presence beyond 2024. The company has already aligned with MDR requirements for Class I medical devices as of Jun 2020, and the transition process is ongoing for Classes IIa and IIb.
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
With the new Medical Device Regulation (MDR) coming into effect in 2024, Surgivalley is fully prepared to meet these updated requirements. These changes are expected to impact Class IIa medical devices, including invasive and electrical devices, and we are ready to ensure full compliance.
As a trusted partner in navigating the new MDR landscape, Surgivalley is the ideal choice. Our robust quality management systems are designed to meet MDR standards, backed by years of experience in developing and manufacturing devices that comply with Annex II, III, and IV requirements of 93/42/EC.
Supplying high-quality surgical instruments to the medical community is at the heart of what we do, and we are well-prepared to adapt to these regulatory changes. Our products are meticulously designed, developed, and manufactured using a unique blend of expertise that allows us to offer exceptional flexibility in today’s dynamic global market. We remain committed to working closely with our partners, even in challenging economic times, to deliver innovative solutions that enhance compliance and reduce costs.
SURGI VALLEY
Surgi Valley is ready for the changes coming to Class IIa medical devices. Considering that the European Commission (EC) already announced in 2019 that it would implement a Single Regulatory Document (SRD) for all Class IIa devices, it is time to prepare for this new regulatory framework
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Class
|
Examples of Devices
|
Description
|
Subclassifications
|
|---|---|---|---|
|
Class I
|
Bandages, stethoscopes, eyeglasses
|
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
|
Hearing aids, catheters, short-term contact lenses
|
Moderate-risk devices requiring higher regulation compared to Class I.
|
N/A
|
|
Class IIB
|
Forceps, scissors, scalpels, ventilators, insulin pens, long-term contact lenses, incubators
|
Higher-risk devices requiring rigorous assessment and conformity procedures
|
N/A
|
|
Class III
|
Surgical mesh, replacement heart valves, breast implants, pacemakers
|
Highest-risk devices subjected to the most stringent regulatory controls, including extensive clinical testing and evaluation.
|
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.
