Medical Devices FAQs
1. Define Medical Device?
A Medical Device is any device that aids both health care professionals and patients to diagnose, treat, overcome sickness or disease and improve their quality of life with safety and efficacy. It can be in the form of instrument, apparatus, equipment, machine, implant, an in-vitro reagent or similar related article with the accessory, component etc. It must have rational assurance or recognition from a standard regulatory authority. Though it is considered to influence any function or structure of the body of humans or animals it doesn’t have any pharmacological effect.
2. Define In-vitro Diagnostic Devices?
The medical device appliances utilized in the examining or studying or investigating of human samples (blood, urine, tissue, etc.) outside of the body in the form of reagents, reagent device, diagnosis kits, instruments, apparatus, equipment or system 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 or disease or congenital abnormality or assess the safety and compatibility with potential recipients. These devices facilitate to detection of infections/diseases, track or observe the progress of drug therapies and diagnose conditions.
You can also check IVD classification.
3. Define Software Device (SaMD)?
Software as Medical Device is a Standalone 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 to support both technology and connectivity to devices in addition to the people so that, 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.
4. Define Active Device?
A medical device that depends on any source of electrical energy or any power of external source for its intended use besides directly generated by the human body or gravity and that acts by converting this energy are an Active Device.
Eg: Ablation devices, Body-worn sensors, Hearing aids, Heart-lung machines, Ventilators, Radiation therapy.
5. Define 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 utilize for their intended use. In simple considered as inert devices uninvolved in energetic pursuits.
Eg. Orthopedic implants, surgical instruments or other sterile single-use devices.
6. Define 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 to sense a physiological response in vivo or to actuate physiological organs.
Eg: coronary stents, hip implants, intraocular lenses and implantable insulin pumps
7. Define 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 are Active Implantable Devices. They are considered as highest risk categorized devices that require meticulous regulatory control to place in the market.
Eg: Implantable cardiac pacemakers and accessories, Implantable cardioverter-defibrillators and accessories, Implantable neurostimulator systems and accessories, Brachytherapy systems and accessories etc.
Related — FDA Medical Device Classification
8. What is CE Marking?
CE marking is a Regulatory marking that designates conformance with health, safety, and environmental protection standards for trade of products within the European Economic Area. Though it is not a quality indicator or a certification mark is required for all new products which are subject to one or more of the European product safety regulations. It is an evident mark 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.
9. What is UKCA Marking?
UKCA marking is United Kingdom Conformity Assessed marking applicable only in Great Britain. It is introduced as a result of Brexit and started on January 1, 2021. It is the recommended UK product marking that the manufacturers need to comply with it for products being placed on the Great Britain market. It is a replacement of the EU requirements for CE Marking on a voluntary basis at present and mandatory after July 1, 2023, only in Britain. The regulatory body that will work together with the existing two EU notified bodies DEKRA Certification BV (0344) and DEKRA Certification GmbH (0124) to moderate the UKCA and the CE marking of manufacturers is DEKRA(Deutscher Kraftfahrzeug-Überwachungs-Verein) UKAB(United kingdom Approved Bodies).
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