Federal Agency for Medecines and Health Products Federal

Federal Agency for Medecines and Health Products Federal Agency for Medicines and Health Products (FAMHP) Medical Devices: Definition and Classification Frédérique Meulders Health Products Division FAMHP/FM 28. 01. 2010 1

Federal Agency for Medecines and Health Products Federal Agency for Medicines and Health Products FAMHP/FM 28012010 2

Federal Agency for Medecines and Health Products Division HP Human Body Material and Blood FAMHP/FM 28012010 • Medical Devices 3

Federal Agency for Medecines and Health Products Classification of medical devices 1. Legislation 2. Definitions 3. Placing on the market 4. Classification 5. Borderline products FAMHP/FM 28012010 4

Federal Agency for Medecines and Health Products 1. Legislation FAMHP/FM 28012010 5

Federal Agency for Medecines and Health Products Legislation • European Directive 90/385/EEC concerning implantable active medical devices transposed in the Royal Decree dated 15 th July 1997 • European Directive 93/42/EEC concerning medical devices transposed in the Royal Decree dated 18 th March 1999 • European Directive 98/79/EEC concerning in vitro diagnostic medical devices transposed in the Royal Decree dated 14 th November 2001 (under the competence of the Scientific Institute for Public Health) FAMHP/FM 28012010 6

Federal Agency for Medecines and Health Products 2. Definitions FAMHP/FM 28012010 7

Federal Agency for Medecines and Health Products Definitions • « medical device » means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: – Diagnosis, prevention, monitoring, treatment or alleviation of disease, – Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, – Investigation, replacement or modification of the anatomy or of a physiological process – Control of conception And which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means FAMHP/FM 28012010 8

Federal Agency for Medecines and Health Products Definitions • « active medical device » means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity • « active implantable medical device » means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure • « accessory » means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device FAMHP/FM 28012010 9

Federal Agency for Medecines and Health Products Examples • Medical devices: Bone cements; materials for sealing, approximation or adhesion to tissues; sutures, intrauterine devices; blood bags; wound dressings; catheters; stents; wheelchairs; hospital beds; contact lenses; …. • Active medical devices: Hearing aids; cryosurgery equipment; lung ventilators; blood warmers; surgical lasers; lithotriptors; therapeutic cyclotrons; gamma cameras, … • Active implantable medical devices: Implantable pacemaker; implantable defibrillator; neurostimulator; cochlear implants + related leads • Accessories: Contact lens care products; disinfectants specifically intended for use with MD; lubricants specifically intended for use together with MD; … FAMHP/FM 28012010 10

Federal Agency for Medecines and Health Products Definitions • « manufacturer » means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on this behalf by a third party. • « authorized representative » means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligation under the Directive medical devices FAMHP/FM 28012010 11

Federal Agency for Medecines and Health Products Definitions • Combination medical device / medicinal product –Drug delivery products • Prefilled syringes, patches for transdermal drug delivery; implants containing medicinal products in a polymer matrix whose primary purpose is to release the medicinal product; intrauterine devices whose primary purpose is to release progestogens • Drug delivery pump, nebulizer, port systems, syringe, … –Medical devices incorporating a medicinal substance Catheters coated with heparin; condoms coated with spermicide; drug eluting coronary stents, … FAMHP/FM 28012010 12

Federal Agency for Medecines and Health Products The medical device directive shall not apply to: • Medicinal products covered by Directive 2001/83/EC • Cosmetic products covered by Directive 76/768/EEC • Human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products plasma or cells with the exception of devices incorporating, as an integral part, a substance which, if used separately may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device FAMHP/FM 28012010 13

Federal Agency for Medecines and Health Products The medical device directive shall not apply to: • Transplants tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin with the exception of devices incorporating, as an integral part, a substance which, if used separately may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device • Transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue FAMHP/FM 28012010 14

Federal Agency for Medecines and Health Products 3. Placing on the market FAMHP/FM 28012010 15

Federal Agency for Medecines and Health Products Placing on the market • CE marking of conformity Except for custom-made devices and devices intended for clinical investigation • Essential requirements • Conformity assessment procedures in order to affix the CE marking FAMHP/FM 28012010 16

Federal Agency for Medecines and Health Products 4. Classification FAMHP/FM 28012010 17

Federal Agency for Medecines and Health Products Classification • 4 classes : I, IIa, IIb and III depending of the duration of use, the invasiveness and of the criticality of the intended use • Duration: –Transient –Short term –Long term • Invasiveness –Body orifice –Surgically invasive device –Implantable device FAMHP/FM 28012010 18

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices FAMHP/FM 28012010 19

Federal Agency for Medecines and Health Products Classification rules: Non invasive devices FAMHP/FM 28012010 20

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices Rule 1 Cervical collar, hospital bed, corrective glasses, noninvasive electrodes, conductive gels, wheelchairs, … FAMHP/FM 28012010 21

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices FAMHP/FM 28012010 22

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices Rule 2 • Medical devices connected to an active medical device in Class IIa or a higher class: tubing intended for use with an infusion pump, antistatic tubing for anesthesia, syringes for infusion pumps, … • Medical devices intended for use for storing or channeling blood or other body liquids or for storing organs, parts of organs or body tissues: devices intended to channel blood in transfusion, devices intended for long term storage of biological substances and tissues such as cornea, sperm, human embryos, … • Class I medical devices falling under rule 2: administration sets for infusion, spoons intended for administering of medicines, syringes without needles FAMHP/FM 28012010 23

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices FAMHP/FM 28012010 24

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices Rule 3 • Class IIb medical devices falling under rule 3: Hemodyalizers, haemodyalisis concentrates, gradient medium for sperm separation, … • Class IIa medical devices falling under rule 3: Centrifugation of blood to prepare it for transfusion, removal of CO 2 from the blood and/or adding O 2, warming or cooling the blood in an extracorporeal circulation system, … FAMHP/FM 28012010 25

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices FAMHP/FM 28012010 26

Federal Agency for Medecines and Health Products Classification rules : Non invasive devices Rule 4 • Class I medical devices falling under rule 4 Cotton wool, wound strips, gauze dressings, … • Class IIb medical devices falling under rule 4 Dressings for chronic extensive ulcerated wounds, for severe decubitus wounds, … • Class IIa medical devices falling under rule 4 Adhesives for topical use, polymer film dressings, nonmedicated impregnated gauze dressings, hydrogel dressings, … FAMHP/FM 28012010 27

Federal Agency for Medecines and Health Products Classification rules: Invasive devices FAMHP/FM 28012010 28

Federal Agency for Medecines and Health Products Classification rules : Invasive devices FAMHP/FM 28012010 29

Federal Agency for Medecines and Health Products Classification rules : Invasive devices FAMHP/FM 28012010 30

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 5 • Transient use: Handheld mirrors used in dentistry, dental impression material, enema devices • Short term-use: Contact lenses, urinary catheters • oral cavity, ear canal and nasal cavity Dressings for nose bleeds, dentures intended to be removed by the patient, … FAMHP/FM 28012010 31

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 5 • long-term use: urethral stents, … • Oral cavity, ear canal, nasal cavity: orthodontic wire, fixed dental prostheses, fissure sealants, … • intended for connection to an active medical: tracheostomy or tracheal tubes connected to a ventilator, powered nasal irrigators, fibre optics in endoscopes connected to surgical lasers, suction catheters or tubes for stomach drainage, … FAMHP/FM 28012010 32

Federal Agency for Medecines and Health Products Classification rules : Invasive devices FAMHP/FM 28012010 33

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 6 • Medial devices surgically invasive for transient use: needles used for suturing, lancets, single use scalpels, surgical swabs, surgical gloves, heart valve occluder, … • Control, diagnose, monitor or correct a defect of the heart or of the central circulatory system: cardiovascular catheters, including related guidewires and dedicated disposable cardiovascular surgical instruments e. g. electrophysiological catheters, electrodes for electrophysiological diagnosis and ablation, … • Reusable instruments: scalpels, drill bits, … FAMHP/FM 28012010 34

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 6 • Supply energy / ionizing radiation: catheters containing or incorporating sealed radioisotopes, where the radioactive isotope as such is not intended to be released into the body, if used in the circulatory system, excluding the central circulatory system, … • biological effect / mainly absorbed: Class IIb • System to administer medicines – potentially hazardous: insulin pens • 21/03/2010: Intended specifically for use in direct contact with the central nervous system are in Class III: Neuroendoscopes, brain spatulas, direct stimulation cannulas, … FAMHP/FM 28012010 35

Federal Agency for Medecines and Health Products Classification rules : Invasive devices FAMHP/FM 28012010 36

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 7 • Medical devices surgically invasive for short-term use: Clamps, infusion cannulas, skin closure devices, … • Control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact: Cardiovascular catheters, Carotid artery shunts, … • For use in direct contact with the central nervous system: Neurological catheters, cortical electrodes, … FAMHP/FM 28012010 37

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 7 • Supply energy /ionizing radiation Brachytherapy devices, … • Biological effect /mainly absorbed Absorbable sutures, … • Undergo chemical change in the body /administer medicines (not in teeth) Adhesives FAMHP/FM 28012010 38

Federal Agency for Medecines and Health Products Classification rules : Invasive devices FAMHP/FM 28012010 39

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 8 • Implantable devices / long-term surgically invasive devices: Stents, intra-ocular lenses, infusion ports, … • To be placed in teeth: Bridges, crowns, … • Used in direct contact with heart or central circulatory system or the central nervous system: Prosthetic heart valves, aneurysm clips, CNS electrodes, … FAMHP/FM 28012010 40

Federal Agency for Medecines and Health Products Classification rules : Invasive devices Rule 8 • Biological effect or mainly absorbed: Absorbable sutures, … • Undergo chemical change in the body or administer medicines (not in teeth) Rechargeable non-active drug delivery systems, … • Directive 2003/12/EC: Breast implants are in Class III • Directive 2005/50/EC: total hip, knee and shoulder joint replacement implants are in Class III FAMHP/FM 28012010 41

Federal Agency for Medecines and Health Products Classification rules: Active devices FAMHP/FM 28012010 42

Federal Agency for Medecines and Health Products Classification rules : Active devices FAMHP/FM 28012010 43

Federal Agency for Medecines and Health Products Classification rules : Active devices Rule 9 • Active therapeutic devices intended to administer or exchange energy External bone growth stimulators, cryosurgery equipment, hearing aids, … • Administer or exchange energy in a potentially hazardous way Lung ventilators, incubators for babies, external defibrillator, linear accelerators, … • Intended to control & monitor or influence directly a class IIb active therapeutic device External feedback systems for active therapeutic devices, … FAMHP/FM 28012010 44

Federal Agency for Medecines and Health Products Classification rules : Active devices FAMHP/FM 28012010 45

Federal Agency for Medecines and Health Products Classification rules : Active devices Rule 10 Active devices intended for diagnosis are in Class IIa: • If they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient’s body, in the visible spectrum, Ex: Magnetic resonance equipment, evoked response stimulators, … • If they are intended to image in vivo distribution of radiopharmaceuticals, Ex: Gamma cameras, positron emission tomography, … FAMHP/FM 28012010 46

Federal Agency for Medecines and Health Products Classification rules : Active devices intended for diagnosis are in Class IIa: • If they are intended to allow direct diagnosis or monitoring of vital physiological processes, Ex: electrocardiographs, electronic thermometers, … unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration activity of CNS in which case they are in Class IIb. Ex: intensive care monitoring and alarm devices , apnea monitors, … Active devices intended to emit inonizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb. Ex: Diagnostic X-ray sources FAMHP/FM 28012010 47

Federal Agency for Medecines and Health Products Classification rules : Active devices FAMHP/FM 28012010 48

Federal Agency for Medecines and Health Products Classification rules : Active devices Rule 11 • Active devices to administer and/or remove medicines & other substances to or from the body Feeding pumps, jet injectors for vaccination, … • If this is in a potentially hazardous way Infusion pumps, ventilators, anesthesia machines, hyperbaric chambers, … FAMHP/FM 28012010 49

Federal Agency for Medecines and Health Products Classification rules : Active devices FAMHP/FM 28012010 50

Federal Agency for Medecines and Health Products Classification rules : Active devices Rule 12 All other active devices are in Class I. Examination lights, hospital beds, wheelchairs, active diagnostic devices intended for thermography, … FAMHP/FM 28012010 51

Federal Agency for Medecines and Health Products Classification rules: Special rules FAMHP/FM 28012010 52

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 53

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 13 • Devices incorporating integral medicinal product liable to act in ancillary way on human Antibiotic bone cements, condoms with spermicide, heparin coated catheters, dressings incorporating an antimicrobial agent where the purpose of such an agent is to provide ancillary action to the wound, … • All devices incorporating, as an integral part, a human blood derivative are in Class III Surgical sealants containing human serum albumin FAMHP/FM 28012010 54

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 55

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 14 • Devices used for contraception or prevention of sexually transmitted diseases Condoms, contraceptive diaphragms, … • If implantable or long term invasive Contraceptive intrauterine devices FAMHP/FM 28012010 56

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 57

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 15 • Specific for disinfecting, cleaning, rinsing devices for contact lenses Contact lens solutions, comfort solutions • For disinfecting other medical devices other than by physical action Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb. Disinfectants specifically intended for instance for non-invasive medical device • 21/03/2010: Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb. Disinfectants, washers or sterilizers for endoscopes, for surgical equipment… FAMHP/FM 28012010 58

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 59

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 16 • Devices specifically intended for recording of X-ray diagnostic images. X-ray films, photostimulable phosphor plates, … FAMHP/FM 28012010 60

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 61

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 17 • Devices utilizing animal tissues or derivatives (not devices in contact only with intact skin) Biological heart valves, porcine xenograft dressings, implants and dressings made from collagen, … FAMHP/FM 28012010 62

Federal Agency for Medecines and Health Products Classification rules : Special rules FAMHP/FM 28012010 63

Federal Agency for Medecines and Health Products Classification rules : Special rules Rule 18 Blood bags FAMHP/FM 28012010 64

Federal Agency for Medecines and Health Products 5. Borderline Products FAMHP/FM 28012010 65

Federal Agency for Medecines and Health Products Borderline products Borderline medical device / medicinal product Article 2(2) of directive 2001/83/EC: In case of doubt, where, taking into account all its characteristics, a product may fall within the definition od a « medicinal product » and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply FAMHP/FM 28012010 66

Federal Agency for Medecines and Health Products Borderline products • Elastoviscous fluids –Case by case analysis • Peritoneal dialysis solutions –Not a medical device FAMHP/FM 28012010 67

Federal Agency for Medecines and Health Products Borderline products • Eye drops intended for /related to the alleviation of « soreness » , « discomfort » , or « irritation » caused by environmental factors – Case by case analysis • Zinc oxide containing creams – Case by case analysis FAMHP/FM 28012010 68

Federal Agency for Medecines and Health Products Borderline products Borderline medical device / biocides • Hand disinfectants – Not a medical device FAMHP/FM 28012010 69

Federal Agency for Medecines and Health Products Links • FAMHP website: http: //www. fagg-afmps. be • Email: meddev@afmps. be / meddev@fagg. be • European Commission Medical Devices: http: //ec. europa. eu/enterprise/sectors/medicaldevices/index_en. htm FAMHP/FM 28012010 70

Federal Agency for Medecines and Health Products Thank you for your attention FAMHP/FM 28012010 71