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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