Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials. Class I devices can be active, such as examination lamps. However, the MDCG 2021–24 Guidance…
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Learn why toys need CE mark and what role it plays in making toys safe for use in Europe. Discover why CE marking is necessary for toys and how I3CGlobal can help with this task. Ensuring Safety: Do Toys Need a CE Mark? In the EU, the safety of people is paramount particularly for products…
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Find out the role of caffeine and the regulation by the FDA concerning labelling in the enhancement of consumer information. We need to know how beneficial labeling is in the enhancement of a customer’s decision to act as well as the promotion of public health. Why Caffeine Labelling Is a Hot Topic Caffeine having a…
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At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that…
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Manufacturers of class II and a few class I class III medical devices must receive FDA 510k clearance before their product can be legally sold in the United States. Role of Biocompatibility Testing in FDA 510k Clearance Biocompatibility is defined as the ability of the material or a medical device to be compatible with the living tissue. …
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A premarket submission made to the FDA demonstrating that the device is at least as safe and effective, Substantially Equivalent (SE), as a legally marketed device that is not subject to PMA. It is a key pathway that any medical device manufacturer planning to market in the U.S. must understand. Predicate Device Predicate devices are…
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A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. Any medical device approved by the FDA Center for Devices and Radiological Health is classified…
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As a means of entering the U.S. market, companies producing medical devices, medications, and related products must follow steps set by the U.S. Food and Drug Administration (FDA). This process involves multiple steps, with one crucial step being the FDA 510k Q Submission. During this step, the FDA provides companies with answers regarding specific regulation areas, requirements,…
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With the current wave of globalization, the environment for any firm wishing to establish itself within the European Union (EU) has a complex set of rules to regulate its operations. Among the crucial requirements for non-EU organizations, a specific principle is the obligation of an EU representative for foreign affairs. This position is essential to monitor…
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One of the vital aspects in drug development is the clinical assessment of products to be marketed. It helps ascertain that a drug is free from any danger or risk as well as effective and proper for usage before being sold in the market. This compulsory process, which goes through rules and regulations, aims to…
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