With the updates in European guidelines, it is now important to understand the definition of a “medical device” and an “In-Vitro Medical Device”.

The EU regulations provide an upgrade in medical devices in the previous directives. According to the new EU MDR, a medical device is any instrument, apparatus, appliance, reagent, implant, material, or any article intended for the use of any of the following medical purposes:

  • Determination, observing, prevention, treatment, or alleviation of disease, disability, and injury where cure of disability and injury is not included.
  • The investigation, substitution, or modification of an anatomical, physiological or pathological process
  • Products expected for sanitizing, cleaning, and cleansing of medical devices
  • Devices for the control and support of conception, even if they achieve their intended purpose by immunological, pharmacological, or metabolic means.
  • Providing information through In-vitro assessment of tests got from a human body

Some additional devices are included in the new regulation’s scope except cosmetic devices. Some of the below devices are from the list of MDD also.

  • Products are brought into the body through surgically invasive methods to change life structures.
  • Products and substances utilized for facial or other subcutaneous fillings.
  • Equipment utilized for liposuction, lipolysis, or lipoplasty.
  • High-power electromagnetic radiation gear utilized for skin therapies like tattoo and hair evacuation
  • Equipment utilizing electrical or attractive flows to energize the brain.

The In-vitro diagnostic medical device regulation explains the following definition of medical device:

An in-vitro diagnostic medical device is any medical device that is a reagent product, reagent, control material, kit, calibrator, apparatus, instrument, piece of equipment, software, system, regardless of whether used alone or in combination, proposed by the manufacturer to be utilized in vitro for the assessment of specimen, including blood or tissue donations derived from the human body primarily to give data on one of the following:

  • Concerning a physiological or neurotic interaction or state;
  • Concerning inherent physical or mental impedances;
  • To decide the security and similarity with expected beneficiaries;
  • Concerning the inclination to an ailment or an illness;
  • To foresee treatment reaction or responses;
  • To characterize or observing helpful measures.

Learn EU MDR and IVDR Compliance Solutions:

  • Gap Assessment and product portfolio rationalization
  • Evaluate QMS
  • Identifying additional SOP or changes to existing SOP required to manage EU MDR
  • Assess AR, importer, and distributor compliance
  • UDI database submission, economic operator, and device registration
  • Evaluate devices that will be recertified to MDR
  • Survey devices with legitimate MDD/AIMD certificates that will be conveyed after 2020

Conclusion

Now medical devices have their definition based on MDR and IVDR, but manufacturers need to understand the definition of medical devices according to these regulations before they start the process to place the devices in the market.