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Examples of Class III medical devices

  • Soledad
  • May 4, 2023
  • 4 min read

Do your own assessment of your medical device classification.

We have prepared the list of examples of medical devices which are class III, organized by MDR rules:


Rule 3 - Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body:

  • Substances or mixture of substances for transport, perfusion, storage of organs intended for transplantation that do not achieve the principal intended action by pharmacological, immunological or metabolic means.

  • IVF or ART products without principal pharmacological/metabolic action (substances or mixture of substances)

  • IVF cell media without human albumin

Rule 6 - Surgically invasive devices intended for transient use (<60 min)

  • Cardiovascular catheters (e.g. angioplasty balloon catheters, stent delivery catheters/systems), including related guidewires, related introducers and dedicated3 disposable cardiovascular surgical instruments e.g. electrophysiological catheters, electrodes for electrophysiological diagnosis and ablation,

  • Catheters containing or incorporating sealed radioisotopes, where the radioactive isotope is not intended to be released into the body, if used in the central circulatory system

  • Distal protection devices

  • Neuro-endoscopes

  • Brain spatulas

  • Direct stimulation cannulae

  • Spinal cord retractors

  • Spinal needles

  • Cranium guide for use in craniotomy

  • Dura mater protection; Bone punch for use on the cranium (Intended use: The dura mater protection is intended to protect the dura mater during surgical procedures. It has direct contact to the CNS. The bone punch can be used at the cranium. A direct contact to the CNS is possible during application.)

  • Peripherally inserted central catheter (PICC) line

  • Heart valve occluders, sizers and holders

  • Cardiovascular drainage cannula specifically intended to circulate blood whilst located in the heart or central vascular system

  • Cryo-ablation of the heart or spine

  • Appliers/Forceps for aneurysm clips

Rule 7 - Surgically invasive devices intended for short-term use (> 60 min <30 days):

  • Cardiovascular catheters

  • Cardiac output probes

  • Temporary pacemaker leads

  • Thoracic catheters intended to drain the heart, including the pericardium

  • Carotid artery shunts

  • Ablation catheter

  • Heart bypass cannula (aortic perfusion cannula and venous drainage cannula)

  • Peripherally inserted central catheter (PICC) line and central line

  • Neurological catheters

  • Cortical electrodes

  • Central venous/vascular catheters

  • Absorbable sutures

Rule 8 - Implantable devices and long-term surgically invasive devices (> 30 days):

  • Prosthetic heart valves

  • Aneurysm clips

  • Vascular prosthesis and stents

  • Central vascular catheters for long-term use

  • Spinal stents

  • CNS electrodes

  • Cardiovascular sutures

  • Permanent and retrievable vena cava filters

  • Septal occlusion devices

  • Intra-aortic balloon pumps

  • External left ventricular assisting devices

  • Long term absorbable sutures

  • Adhesives and implantable devices claimed to be bioactive through the attachment of surface coatings such as phosphoryl choline

  • Biodegrable Bone Cements

  • Elastoviscus fluids for joint movement(eg. hyaluronan of non-animal origin)

  • Rechargeable non-active drug delivery systems

  • Peritoneal dialysis

  • Cochlear implants and accessories

  • Implantable cardiac pacemakers

  • Implantable cardioverter defibrillators (ICD)

  • Leads, electrodes, adaptors for pacemakers and implantable defibrillators

  • Implantable nerve stimulators

  • Implantable bladder stimulators

  • Implantable sphincter stimulators

  • Accessories to active implantable devices (with or without contact to the heart), be it implantable or non-implantable active or not

  • torque wrench for implantable pulse generator / implantable cardioverter defibrillator

  • cables for programmer / pacing system analyser

  • magnet for Implantable Pulse Generator / Implantable Cardioverter Generator

  • programmer or an external transmitter intended for activating or controlling the implantable part of the device

  • implantable pacemaker leads

  • Breast implants

  • Breast tissue expanders

  • Surgical meshes for hernia repair

  • Tension free vaginal tape

  • Hip, knee

  • Shoulder

  • Ankle

  • Spinal disc replacement implants

  • Spinal implants: hooks that fix the rod on the spinal column

  • Stems that are implantable in contact with the spinal column

  • Device placed in the disc space

  • Interbody fusion devices

Rule 9 - Active therapeutic devices intended to administer or exchange energy, as well as active devices intended to control/monitor/directly influence certain devices:

  • Programming units and pacing system analysers

  • Cardioscopes with pacing pulse indicators specifically intended to monitor active implantable devices

  • Programmer for:

    • implantable Pulse Generator (IPG);

    • implantable Cardioverter Defibrillator (ICD)

    • implantable Loop Recorder

  • Remote monitoring devices for active implantable devices

Rule 14 - Devices incorporating, as an integral part, an ancillary medicinal product, and medicinal products derived from human blood or blood plasma:

  • Bone cement with antibiotics

  • Condoms with spermicide

  • Catheters coated with anticoagulants (e. g. heparin)

  • Endodontic materials with antibiotics

  • Ophthalmic irrigation solutions principally intended for irrigation, which contain components supporting the metabolism of the endothelial cells of the cornea

  • Dressings incorporating an antimicrobial agent where the agent has an ancillary action on the wound

  • Drug eluting stents (e.g. coronary, pulmonary)

  • Surgical sealants containing human serum albumin or thrombin

  • Implants coated with human fibrinogen

  • Blood bags incorporating heparin or other substances as anticoagulant agents which, if used separately, can be considered to be a medicinal product

  • IVF cell media with human albumin

  • Intra Uterine Devices (IUD) containing medicinal substances including copper or silver

  • Catheter lubrication gels containing analgesia e.g. lidocaine

Rule 15 - Devices used for contraception or prevention of sexually transmitted diseases:

  • Tubal ligation devices (e.g. clips or rings)

  • Non-hormonal intrauterine contraceptive devices (IUCD or ICD)

Rule 18 - Devices manufactured utilizing tissue or cells of human or animal origin or their derivatives:

  • Animal derived biological heart valves

  • Porcine xenograft dressings

  • Devices made from animal sourced collagen/gelatine

  • Devices utilising hyaluronic acid of animal origin

  • Substance-based devices containing collagen for use in body orifices

  • Collagen dermal fillers

  • Bone graft substitutes

Rule 19 - Devices incorporating or consisting of nanomaterial:

  • Bone fillers with nanomaterials in their formulation (not polymerized before blood/tissue contact, and degradable)

  • Superparamagnetic iron oxide nanoparticles (Intended use: thermal ablation of tumors or thermal modulation of the tumor microenvironment by submission to alternating magnetic fields)

  • Intravascular catheter made of non-degradable polymer, with nano-coating

Rule 21 - Devices composed of substances that are introduced via a body orifice or applied to the skin:

  • Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body

Rule 22 - Active therapeutic devices, with an incorporated diagnostic function:

  • Automated external defibrillators (AED) including their pads/electrodes

  • Semiautomatic external defibrillators

  • Automated closed loop insulin delivery system

  • Automated external infusion pumps with integrated sensors to adapt the infusion therapy

  • Devices in brain-computer interfaces (BCIs) – used for e.g. motor control in severely paralyzed patients

  • Closed-loop systems for deep brain stimulation (DBS) treatment of various neurological conditions

  • Closed-loop dynamic neurochemical control of therapeutic interventions e.g. target-controlled anaesthesia / infusion systems



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