Medical Device Acronyms
What does CE in "CE-mark" stand for? Spelling counts.
What is Conformité Européene?
These surgical instruments are considered some of the earliest known pieces of medical equipment, dating to nearly 3000 BC.
What are cutting tools (such as scalpels and bone saws)?
This document, issued by the MDCG, provides guidance related to determining equivalence between a subject device and a secondary device.
What is MDCG 2020-5?
In the EU, all non-invasive devices are considered this classification (unless another rule applies).
What is a Class I medical device?
This Marvel superhero genius is known for having a what-may-be-described-as Class III implantable device that keeps his heart running.
Who is Iron Man (Tony Stark)?
This professional society is the largest global organization of professionals involved with regulatory and quality for healthcare products.
What is the Regulatory Affairs Professionals Society?
This family of devices are used to provide stable vascular access during minimally invasive endovascular procedures.
What are introducer sheaths?
This specific analysis may be considered the main purpose of the clinical evaluation.
What is the risk-benefit ratio?
What is class IIa?
In 2021, Lil Uzi Vert had this surgically implanted into his forehead, sparking debate about body modification and implant safety.
What is a diamond?
These US and European post-market surveillance tools are used to monitor device performance and detect safety issues, respectively.
What is Medical Device Reporting (MDR) and Medical Device Vigilance (MDV)?
This type of orthopedic device stabilizes broken bones internally using plates, screws, or rods?
What is an internal fixation device?
This section of the MDR text guides evaluators to clinical evaluation methods beyond clinical data.
What is Article 61(10)?
This designation is reserved for devices that do not have any clear predicate device or may introduce new technologies or may satisfy a new medical niche.
What is a novel device?
This sci-fi classic heavily features "neural implants" that keep their human users locked in a digital reality.
What is The Matrix?
This specific type of application is required for Class III devices in the United States.
What is a PMA (Pre-market approval)?
This is the generic procedural term to describe the minimally invasive procedure performed to open arteries blocked by plaque.
This is the process of testing to ensure that the product being developed meets the needs and requirements of the end users.
What is Design Validation?
Rule 8: All implantable devices and long-term surgically invasive devices are classified as class IIb are designated as this classification (barring a long list of exceptions).
What is class IIb?
This 2013 film starring Matthew McConaughey highlighted the difficult hurdles faced by some when fighting for access to unapproved medical treatments.
What is Dallas Buyers Club?
This acronym is the regulatory body that seeks to harmonize vigilance reporting requirements by creating reporting codes for different types of adverse events.
What is the IMDRF? (International Medical Device Regulators Forum)
This device is a mechanical pump that is surgically implanted into patients with advanced heart failure to assist in pumping blood to the body.
What is a left ventricular assist device (LVAD)?
This ISO sets the standards for evaluating the biocompatibility of medical devices in order to manage biological risk to users.
What is ISO 10993?
This designation is reserved for devices that are intended for the prevention, prediction, diagnosis, support, or treatment of a life-threatening or chronically debilitating disease with a total prevalence of less than 12,000 patients.
What is an orphan device?
This 2018 Netflix original documentary details events, including cobalt poisoning connected to hip replacements, that criticize the FDA's 510(k) process.
What is The Bleeding Edge?