Table of Contents
What is the current Medical Device Directive?
The EU MDD stipulates that: Medical devices must not compromise the clinical condition or safety of patients. Medical devices must not present any risk to the persons implanting them, nor to others. Devices must perform as intended by the manufacturer.
What are the objectives and scope of Medical Device Directive 93 42 EEC?
The Directive: MDD 93/42/EEC The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article.
What are the classifications for devices classified under the Medical Device Directive in the EU?
The MDR designates four medical device classifications: Class I. Class IIa. Class IIb….Class I Medical Devices
- Class Is: The medical device must be presented sterile.
- Class Im: The medical device has a measuring feature.
- Class Ir: The medical device is a reusable surgical instrument.
What defines a medical device?
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.
What is MDR certification?
What is MDR certification? MDR certification of a medical device verifies that the device meets all of the regulatory requirements for European Union medical devices; the certification is indicated by a CE Mark. In order for medical devices to be certified, your company must implement a Quality Management System (QMS).
What is the definition of medical device according to FDA?
Definition of a Medical Device. Section 201(h) of the Food, Drug & Cosmetic Act. (FD&C Act) defines a device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar.
What is the legal definition of a medical device?
medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: Sample 1Sample 2Sample 3.