What Are the Different Types of Registered Medical Devices?
Before a medical device is approved for use in patient care, it must be cleared by various regulatory bodies to ensure the utmost safety and compliance. Richmond Dental and Medical’s disposable products are FDA Class 1 Medical Devices, with the exception being Face Masks, which are Class II. The purified cotton used in Richmond’s products meet US Pharmacopoeia standards, as well as European, Japanese, and Korean Pharmacopoeia. Let’s discuss a few of the major agencies and regulations tasked with certifying medical devices, and what this means for you.
European Medical Device Regulation (MDR)
As of May 2021, the MDR came into full effect for medical devices and borderline products such as cosmetics, herbal medicines, and food supplements sold to countries within the European Union (EU). As the new regulatory framework that will be utilized by the European Medicines Agency going forward, it introduces updated and more comprehensive quality and safety standards with increased transparency throughout the product lifecycle. Manufacturers, importers, and distributors of medical devices in the EU are urged to brush up on the new guidelines that govern clinical investigations, production, and sales of medical devices in Europe, as previous MDD compliance is just not enough. The new MDR will require Unique Device Identification (UDI) to enhance traceability and registration in the EUDAMED database.
CE Marking Certification
A CE marking is required for all medical devices sold within the EU. If a product is determined to need a CE mark, the manufacturer must ensure it meets the health, safety, and environmental standards set forth by the EU governing body. It is the sole responsibility of the manufacturer to complete their due diligence and confirm that all steps of this process (including Essential Requirements, Product Conformity, Technical Documentation, Notified Body, etc.) are compliant with the EU’s New Approach Directives. Once obtained, this mark is a clear indication to consumers and distributors that a medical device fully complies with the established rules and regulations.
The UK will recognize the CE Mark until January 2022. The new UK Conformity Assessed Mark will be issued by a UK Approved Body for goods to be sold that were previously subject to the CE Mark.
Food and Drug Administration (FDA)
While there are some exceptions, a majority of medical devices sold within the United States are required to be registered with and approved by the FDA. For the highest risk devices, such as mechanical heart valves and implantable infusion pumps, manufacturers are required to present sufficient scientific evidence proving that they are safe and effective for accomplishing their intended purpose. Additionally, manufacturers of these types of devices are required to submit Premarket Approval (PMA) applications before marketing and selling to consumers.
Medical Device Reporting (MDR) Regulation
While the Medical Device Regulation and Medical Device Reporting share the same acronym, they are very different. The Medical Device Reporting regulation refers to the mandatory requirements for manufacturers, distributors, importers, and device user facilities, such as hospitals and assisted care homes, to report device-related adverse events to the FDA. For instance, if a manufacturer receives word that their medical device has caused a serious injury or death, they are mandated to submit a full report to the FDA so the agency can do their own investigation.
For products made and sold in America, the stringent guidelines put forth by the FDA are in place to protect consumers, manufacturers, and distributors alike. At Richmond Dental and Medical, we pride ourselves on providing top-quality medical and dental disposables that meet all FDA regulations. To ensure the ultimate legal compliance and workmanship of all our products, we manufacture in the United States at FDA-registered facilities. Whether you need our Soft BiteBlock® to protect your patients’ airway, teeth, and tongue during emergence from anesthesia, our cotton nonwoven sponges for oral surgery, or our pellets for endodontic applications, you can rest assured that they meet the FDA’s comprehensive safety and quality regulations for Class 1 Medical Devices.
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