Examples of Class III medical devices

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