What is UKCA certification?
The United Kingdom Conformity Assessed Certification, or UKCA Marking, is only legal in the United Kingdom. It was implemented in response to Brexit and went into effect on January 1, 2021. Manufacturers must adhere to the recommended UK product labeling in order for their items to be sold in Great Britain. It serves as a substitute for the EU CE marking regulations, which are now voluntary but will become required in Britain only as of July 1, 2023.
What is CE certification?
CE marking is a regulatory marking that designates conformance with health, safety, and environmental protection standards for the trade of products within the European Economic Area. Though it is not a quality indicator or a certification mark, it is required for all new products that are subject to one or more of the European product safety regulations. It is an evident sign that the product manufacturer is proclaiming conformity with all of the regulations and instructions relating to the particular product. CE marking is no longer valid in Great Britain after July 1, 2023. The US system does not use CE marking.
What is a “medical device”?
What are in-vitro diagnostic devices?
The medical device appliances utilized in the examining, studying, or investigating of human samples (blood, urine, tissue, etc.) outside of the body in the form of reagents, reagent devices, diagnosis kits, instruments, apparatus, equipment, or systems, either used alone or in combination intended by the manufacturer, are in-vitro diagnostic devices. They give details or data regarding a physiological state of health, disease, or congenital abnormality, or assess the safety and compatibility of potential recipients. These devices facilitate detecting infections and diseases, tracking or observing the progress of drug therapies, and diagnosing conditions.
What is a software device (SaMD)?
Software as a Medical Device is stand-alone software that performs medical functions devoid of hardware in the form of medical apps, web-based apps, etc. Generally, it is utilized with non-medical computing platforms connected to virtual networks. It is accomplished by supporting both technology and connectivity to devices in addition to people so that they can continuously monitor safety, efficacy, and performance. It includes specific classification based on risk-based criteria and clinical evaluation as a priority. The main and basic concern of SaMD is to ensure patient safety and clinical efficacy without giving up faster innovation.
What is an active device?
A medical device that depends on any source of electrical energy or any power from an external source for its intended use other than directly generated by the human body or gravity and that acts by converting this energy is an active device. e.g., ablation devices, body-worn sensors, hearing aids, heart-lung machines, ventilators, and radiation therapy.
What is a non-active device?
Non-active devices are those medical devices that don’t require any source of energy or any external source of power to be utilized for their intended use. It simply considered inert devices to be uninvolved in energetic pursuits. e.g., orthopedic implants, surgical instruments, or other sterile single-use devices.
What is known as an implantable device?
A medical device that is either partly or completely introduced for surgical or medical purposes into the human body and is intended to remain there after the procedure is defined as an implantable device.” They provide the benefit of sensing a physiological response in vivo or actuating physiological organs. e.g., coronary stents, hip implants, intraocular lenses, and implantable insulin pumps
What is an active implantable device?
Any powered medical device that is inserted into the human body for diagnostic or therapeutic purposes and is intended to remain in place is an active implantable device. They are considered the highest-risk categorized devices, which require meticulous regulatory control to be placed on the market. Eg: implantable cardiac pacemakers and accessories; implantable cardioverter-defibrillators and accessories; implantable neurostimulator systems and accessories; brachytherapy systems and accessories, etc.