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Medical Device Regulations

As of 2017, the Medical Device Directive (MDD), which has been in place since 2002, has been repealed by the EU Medical Device Regulation (MDR), set to fully replace it in 2024. Regal International Surgical Instruments is prepared for this transition, having established an MDR transition program since July 2021 to ensure compliance with the new regulations.

Regal International aims to become EMDR-certified within the next year for all classes of medical devices, ensuring our continued presence in the market after 2024. We are currently conforming to MDR regulations for class I medical devices, with an ongoing transition between classes LLA and LLB.

Our company has effectively utilized the additional grace period available. Following a successful audit by SGS Belgium, our ISO 13485 certification was recently renewed. We are adequately prepared to maintain excellent data integrity standards and minimize costs associated with rushed deployments by leveraging this grace period.

We Are MDR-Ready at Regal International Instruments

With the new Medical Device Regulation (MDR) set to take effect in 2024, Regal International Instruments is fully prepared to meet these standards. These regulations are expected to impact Class IIa medical devices, including invasive and electrical devices.

As a company well-positioned to guide you through the new MDR requirements, Regal International Instruments is your ideal partner. Our quality management systems are ready for MDR compliance, backed by years of experience in developing and manufacturing devices that meet Annex II, III, and IV requirements of 93/42/EC.

As we supply surgical instruments to the medical community, we are prepared for these upcoming changes to ensure we continue delivering high-quality products. Our offerings are designed, developed, and manufactured with a unique blend of expertise, providing a wide range of flexibility in today’s dynamic global market. We will continue to work closely with our partners to deliver innovative solutions that enhance compliance and reduce costs.

Regal International Surgical Instruments

Regal International Surgical Instruments is fully prepared for the upcoming changes affecting Class IIa medical devices. With the European Commission (EC) announcing in 2017 the implementation of a Single Regulatory Document (SRD) for all Class IIa devices, it’s time to adapt to this new regulatory framework.

The Medical Device Directive (MDD), in place since 2002, was repealed by the EU Medical Device Regulation (MDR), which will be fully effective in 2024. Regal International Surgical Instruments is ready to transition to the MDR as soon as it becomes effective. Since July 2021, we have had an MDR transition program in place to ensure compliance with the new regulations.

We anticipate becoming EMDR-certified within the next year for all classes of medical devices to maintain our market presence after 2024. Additionally, we are aligning our processes to meet MDR requirements for Class I medical devices, with ongoing transitions between classes LLA and LLB.

Classification of MDR Medical Devices

ClassExamples of DevicesDescription
Class IBandages, stethoscopes, eyeglassesClass I devices are considered low-risk and are subject to general controls. They are non-invasive and do not pose a significant risk to patients. Regal International Instruments ensures complete product identification and traceability through UDI Codes and ISO 15223-1 labels.
Sub-classifications:
- Is (sterile condition)
- IM (measuring function)
- IR (reusable surgical)
These sub-classifications categorize devices based on specific characteristics such as sterility, measuring function, and reusability.
Class IIAHearing aids, catheters, short-term contact lensesClass IIA devices are of moderate risk and require a higher level of regulation compared to Class I.
Class IIBForceps, scissors, scalpels, ventilators, insulin pens, long-term contact lenses, incubatorsClass IIB devices pose a higher level of risk than Class I and IIA devices. They require a more rigorous assessment and conformity assessment procedure.
Class IIISurgical mesh, replacement heart valves, breast implants, pacemakersClass III devices are the highest-risk category and undergo the most stringent regulatory control. These devices require extensive clinical testing and evaluation before approval for use.