Federal Agency for Medicines and Health Products

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2. FederalAgency for Medicines and Health Products 2

3. Health Products Division 3

4. Classification of medical devices • Legislation • Definitions • Placing on the market • Classification • Borderline products 4

5. 1. Legislation 5

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

7. 2. Definitions 7

8. « 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 Definitions 8

9. «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 Definitions 9

10. 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;… Examples 10

11. «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 Definitions 11

12. 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,… Definitions 12

13. 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 The medical device directive shall not apply to: 13

14. 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 The medical device directive shall not apply to: 14

15. 3. Placing on the market 15

16. 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 16

17. 4. Classification 17

18. 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 Classification 18

19. Classification rules : Non invasive devices 19

20. Classification rules: Non invasive devices 20

21. Rule 1 Cervical collar, hospital bed, corrective glasses, non-invasive electrodes, conductive gels, wheelchairs,… Classification rules : Non invasive devices 21

22. Classification rules : Non invasive devices 22

23. 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 Classification rules : Non invasive devices 23

24. Classification rules : Non invasive devices 24

25. 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 CO2 from the blood and/or adding O2, warming or cooling the blood in an extracorporeal circulation system,… Classification rules : Non invasive devices 25

26. Classification rules : Non invasive devices 26

27. 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, non-medicated impregnated gauze dressings, hydrogel dressings,… Classification rules : Non invasive devices 27

28. Classification rules: Invasive devices 28

29. Classification rules : Invasive devices 29

30. Classification rules : Invasive devices 30

31. 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,… Classification rules : Invasive devices 31

32. 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,… Classification rules : Invasive devices 32

33. Classification rules : Invasive devices 33

34. 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,… Classification rules : Invasive devices 34

35. 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,… Classification rules : Invasive devices 35

36. Classification rules : Invasive devices 36

37. 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,… Classification rules : Invasive devices 37

38. 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 Classification rules : Invasive devices 38

39. Classification rules : Invasive devices 39

40. 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,… Classification rules : Invasive devices 40

41. 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 Classification rules : Invasive devices 41

42. Classification rules: Active devices 42

43. Classification rules : Active devices 43

44. 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,… Classification rules : Active devices 44

45. Classification rules : Active devices 45

46. 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,… Classification rules : Active devices 46

47. 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 Classification rules : Active devices 47

48. Classification rules : Active devices 48

49. 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,… Classification rules : Active devices 49

50. Classification rules : Active devices 50