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2 | MEDICAL DEVICE TECHNICAL AREA (MDTA) VS. CONFORMITY ASSESSMENT BODY (CAB) | |||||||||||||||||||||||||||||
3 | Revised by: CAB Registration Unit (CABRU) 21 November 2025 | |||||||||||||||||||||||||||||
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5 | Technical Area | Description | Examples of Devices (non-exhaustively) | TÜV SÜD | SGS | SIRIM | BSI | DQS | RHEINLAND | NORD | CARE | CI | KGS | DNV | GENUINE | ASI | MEDIVICE | KIWA | AQC | NIOSH | PLATINUM | LEADER | INTERTEK | STRAIT | AMDEXT | PRECISION | ARG | TOTAL | ||
6 | ISO 13485 | Quality Management System for Medical Devices – Requirements for Regulatory Purpose | - | 10 | 4 | 11 | 9 | 4 | 3 | 2 | 13 | 1 | 7 | 3 | 6 | 2 | 3 | 4 | 4 | 3 | 2 | 4 | 3 | 4 | 1 | 4 | 5 | 112 | ||
7 | GDPMD | Good Distribution Practice for Medical Devices | - | 11 | 8 | 15 | 9 | 4 | 3 | 7 | 14 | 2 | 7 | 3 | 7 | 2 | 8 | 5 | 4 | 3 | 3 | 5 | 4 | 4 | 1 | 4 | 6 | 139 | ||
8 | VERIFICATION | Conformity Assessment by Way of Verification | - | 9 | 5 | 14 | 8 | 3 | 4 | 4 | 14 | 2 | 5 | 3 | 7 | 2 | 9 | 4 | 3 | 3 | 2 | 4 | 3 | 5 | 1 | 2 | 5 | 121 | ||
9 | MD 0101 | Non-active devices for anesthesia, emergency and intensive care | Manual resuscitators, anesthesia masks, oxygen masks, nebulizer masks, endotracheal tubes, laryngeal masks, oropharyngeal and nasopharyngeal airways, manual suction pumps, breathing circuits, ambu bags (Bag-Valve-Mask devices), CPR boards, nebulizer kits (non-powered), chest seals, thermal blankets (non-active). | 7 | 1 | 1 | 1 | 2 | 2 | 1 | 1 | 3 | 3 | 1 | 1 | 2 | 1 | 1 | 2 | 30 | ||||||||||
10 | MD 0102 | Non-active devices for injection, infusion, transfusion and dialysis | Syringes, infusion sets, blood transfusion sets, dialysis filters, needles, IV catheters, IV solution bags, drip chambers, dialysis tubing sets, blood collection bags, subcutaneous infusion ports, heparin locks, gravity infusion devices, filter needles. | 5 | 2 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 26 | ||||||||||||
11 | MD 0103 | Non-active orthopedic and rehabilitation devices | Knee braces, orthotic insoles, crutches, physical therapy bands, splints, walking aids, orthopedic shoes, cervical collars, wheelchairs (non-powered), ankle braces, therapeutic cushions, compression garments, finger or hand splints, body belts. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 11 | |||||||||||||||
12 | MD 0104 | Non-active medical devices with measuring function | Thermometers, sphygmomanometers, stethoscopes with pressure indicators, height measuring scales, weighing scales, peak flow meters, tape measures, calipers, pulse oximetry probes (non-active), urine test strips, ophthalmic tonometers (manual), mechanical spirometers, blood glucose lancets (manual puncture). | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 15 | ||||||||||||||
13 | MD 0105 | Non-active ophthalmologic devices | Eyeglass frames, eye patches, tonometer prisms, contact lens cases, trial lens sets, lens blanks, eye speculums, artificial eyes (ocular prostheses), punctal plugs, eye shields, manual keratometers, scleral depressors, ophthalmic prisms. | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 9 | |||||||||||||||||||
14 | MD 0106 | Non-active instruments | Surgical forceps, scalpels, curettes, retractors, needle holders, tissue scissors, bone chisels, hemostats, speculums, probe and grooved directors, amputation knives, dilators, biopsy punches. | 1 | 1 | 2 | 1 | 2 | 2 | 2 | 1 | 2 | 3 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 3 | 32 | ||||||
15 | MD 0107 | Contraceptive medical devices | Intrauterine devices (IUDs), condoms, diaphragm contraceptives, cervical caps, spermicide applicators, contraceptive sponges, female condoms, vasectomy clamps, sterilization clips or rings, copper IUDs, hormonal IUDs, contraceptive diaphragms with applicators, cycle monitoring devices (non-active). | 7 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 20 | |||||||||||||||
16 | MD 0108 | Non-active medical devices for disinfecting, cleaning, rinsing | Sterilization pouches, cleaning brushes, ultrasonic cleaning units, instrument trays, sterilization wraps, manual disinfectant applicators, rinse bottles, brushes for endoscope cleaning, soaking basins, autoclave indicator strips, water filtration units (non-active), chemical sterilization containers, hand scrub dispensers (manual). | 3 | 1 | 2 | 1 | 1 | 2 | 2 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 2 | 24 | ||||||||||
17 | MD 0109 | Non-active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART) | Catheters for embryo transfer, IVF culture dishes, pipettes for oocyte manipulation, embryo freezing straws, oocyte retrieval needles, sperm preparation tubes, cryopreservation vials, microtools for ICSI (intracytoplasmic sperm injection), petri dishes for gamete culture, media transfer pipettes, embryo transfer cannulas, embryoscope dishes, hatching needles. | 1 | 1 | |||||||||||||||||||||||||
18 | MD 0201 | Non-active cardiovascular implants | Heart valve implants, vascular grafts, occlusion devices, stents (non-drug-eluting), annuloplasty rings, artificial pacemaker leads (non-active), arterial patches, vena cava filters, septal occluders, pulmonary conduits, endovascular grafts, prosthetic vascular access ports, biological vascular grafts. | 1 | 1 | 2 | ||||||||||||||||||||||||
19 | MD 0202 | Non-active orthopedic implants | Joint replacement implants, bone screws, plates for fracture fixation, intramedullary nails, spinal cages, hip replacement implants, knee replacement implants, shoulder implants, orthopedic pins, external fixation frames, bone plates and locking screws, elbow and wrist implants, custom implants. | 2 | 2 | 2 | 1 | 1 | 2 | 1 | 11 | |||||||||||||||||||
20 | MD 0203 | Non-active functional implants | Cochlear implants without electronics, mechanical stents, heart valve repair rings, bone graft substitutes, tendon and ligament grafts, corneal implants, urinary stents, hernia meshes, facial reconstruction implants, silicone breast implants (non-gel), joint spacers, esophageal stents. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
21 | MD 0204 | Non-active soft tissue implants | Breast implants, hernia meshes, dermal fillers, facial implants, buttock implants, abdominal wall prostheses, nasal implants, tissue expanders, lip implants, collagen-based implants, scar management implants, pelvic floor repair meshes, pectoral implants. | 2 | 1 | 1 | 1 | 5 | ||||||||||||||||||||||
22 | MD 0301 | Bandages and wound dressings | Adhesive bandages, hydrocolloid dressings, alginate dressings, gauze pads. | 2 | 1 | 1 | 1 | 2 | 1 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 21 | |||||||||||
23 | MD 0302 | Suture material and clamps | Absorbable and non-absorbable sutures, surgical staples, hemostatic clamps. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
24 | MD 0303 | Other medical devices for wound care | Negative pressure wound therapy (NPWT) systems, wound irrigation devices, skin closure strips. | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 10 | |||||||||||||||||
25 | MD 0401 | Non-active dental equipment and instruments | Dental mirrors, explorers, scalers, saliva ejectors. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
26 | MD 0402 | Dental materials | Dental cements, composite resins, dental impression materials. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
27 | MD 0403 | Dental implants | Titanium dental implants, zirconia dental implants, abutments. | 1 | 1 | 2 | ||||||||||||||||||||||||
28 | MD 1101 | Devices for extra-corporal circulation, infusion and haemopheresis | Blood oxygenators, dialysis machines, plasmapheresis devices. | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 11 | ||||||||||||||||
29 | MD 1102 | Respiratory devices, including hyperbaric chambers for oxygen therapy, inhalation anesthesia | Mechanical ventilators, CPAP machines, hyperbaric oxygen chambers. | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 10 | ||||||||||||||||||
30 | MD 1103 | Devices for stimulation or inhibition | TENS machines, deep brain stimulators. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7 | |||||||||||||||||||
31 | MD 1104 | Active surgical devices | Electric surgical scalpels, laser surgical systems. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | ||||||||||||||||||
32 | MD 1105 | Active ophthalmologic devices | Retinal laser devices, phacoemulsification machines. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
33 | MD 1106 | Active dental devices | Dental drills, ultrasonic scalers. | 1 | 1 | 1 | 1 | 1 | 1 | 6 | ||||||||||||||||||||
34 | MD 1107 | Active devices for disinfection and sterilization | Autoclaves, ultraviolet sterilizers. | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 8 | |||||||||||||||||||
35 | MD 1108 | Active rehabilitation devices and active prostheses | Motorized wheelchairs, powered exoskeletons. | 1 | 1 | 1 | 1 | 1 | 5 | |||||||||||||||||||||
36 | MD 1109 | Active devices for patient positioning and transport | Electric patient hoists, powered hospital beds. | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 9 | ||||||||||||||||||
37 | MD 1110 | Active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART) | Micro-manipulators, cryopreservation tanks with electronics. | 1 | 1 | |||||||||||||||||||||||||
38 | MD 1111 | Software | Diagnostic imaging software, electronic health record systems. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
39 | MD 1201 | Imaging devices utilizing ionizing radiation | X-ray machines, CT scanners. | 1 | 1 | 2 | 1 | 2 | 7 | |||||||||||||||||||||
40 | MD 1202 | Imaging devices utilizing non-ionizing radiation | MRI machines, ultrasound devices. | 1 | 1 | 2 | 2 | 1 | 1 | 2 | 10 | |||||||||||||||||||
41 | MD 1301 | Monitoring devices of non-vital physiological parameters | Body temperature monitors, pulse oximeters, pedometers. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7 | |||||||||||||||||||
42 | MD 1302 | Monitoring devices of vital physiological parameters | ECG monitors, blood pressure monitors, fetal heart rate monitors. | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 11 | |||||||||||||||||
43 | MD 1401 | Devices utilizing ionizing radiation | X-ray machines, fluoroscopy systems, linear accelerators for radiotherapy. | 1 | 1 | 2 | 4 | |||||||||||||||||||||||
44 | MD 1402 | Devices utilizing non-ionizing radiation | Ultrasound scanners, MRI machines, infrared thermometers. | 1 | 1 | 1 | 1 | 2 | 6 | |||||||||||||||||||||
45 | MD 1403 | Devices for hyperthermia / hypothermia | Heating blankets, cooling caps, cryotherapy machines. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
46 | MD 1404 | Devices for (extracorporeal) shock-wave therapy (lithotripsy) | Extracorporeal shock wave lithotripters, devices for musculoskeletal shock-wave therapy. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
47 | AIMD 0101 | Active implantable medical devices for stimulation/inhibition | Implantable pacemakers, neurostimulators. | 0 | ||||||||||||||||||||||||||
48 | AIMD 0102 | Active implantable medical devices delivering drugs or other substances | Insulin pumps, intrathecal drug delivery systems. | 0 | ||||||||||||||||||||||||||
49 | AIMD 0103 | Active implantable medical devices substituting or replacing organ functions | Artificial hearts, implantable defibrillators. | 0 | ||||||||||||||||||||||||||
50 | IVD 0101 | AB0 system | Blood grouping reagents, anti-A and anti-B reagents. | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 8 | |||||||||||||||||||
51 | IVD 0102 | Rhesus (C, c, D, E, e) | Anti-D reagents, Rh-typing kits. | 1 | 1 | 1 | 2 | 1 | 6 | |||||||||||||||||||||
52 | IVD 0103 | Anti-Kell | Anti-Kell blood grouping reagents. | 1 | 1 | 1 | 1 | 4 | ||||||||||||||||||||||
53 | IVD 0201 | HIV infection (HIV 1 and 2) | Rapid diagnostic tests (RDTs) for HIV, ELISA kits for HIV detection. | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 2 | 12 | ||||||||||||||||||
54 | IVD 0202 | HTLV I and II | HTLV I/II antibody detection kits, nucleic acid amplification tests (NAATs) for HTLV. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
55 | IVD 0203 | Hepatitis B, C and D | Hepatitis B surface antigen (HbsAg) test kits, Hepatitis C antibody test kits. | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 13 | ||||||||||||||||
56 | IVD 0301 | Anti-Duffy and anti-Kidd | Blood typing reagents for Duffy and Kidd antigens. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
57 | IVD 0302 | Irregular anti-erythrocyte antibodies | Indirect antiglobulin test (IAT) kits, reagents for unexpected antibody screening. | 1 | 1 | 2 | ||||||||||||||||||||||||
58 | IVD 0303 | Congenital infections: rubella, toxoplasmosis | Rubella IgM and IgG test kits, Toxoplasma gondii antibody test kits. | 1 | 1 | 1 | 2 | 1 | 6 | |||||||||||||||||||||
59 | IVD 0304 | Hereditary disease: phenylketonuria | Phenylalanine detection strips, newborn screening kits for PKU. | 1 | 1 | |||||||||||||||||||||||||
60 | IVD 0305 | Human infections: cytomegalovirus, chlamydia | CMV IgM and IgG test kits, Chlamydia rapid tests, nucleic acid tests (NATs) for chlamydia. | 2 | 1 | 2 | 1 | 3 | 9 | |||||||||||||||||||||
61 | IVD 0306 | HLA tissue groups: DR, A, B | HLA typing kits for organ transplant compatibility. | 1 | 1 | 2 | ||||||||||||||||||||||||
62 | IVD 0307 | Tumoral marker: PSA | Prostate-specific antigen (PSA) immunoassays, chemiluminescent assays for PSA. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7 | |||||||||||||||||||
63 | IVD 0308 | Risk of trisomy 21 (incl. software) | Non-invasive prenatal testing (NIPT) kits, trisomy 21 screening algorithms integrated in laboratory software. | 0 | ||||||||||||||||||||||||||
64 | IVD 0309 | Device for self-diagnosis: device for the measurement of blood sugar | Glucometers, blood glucose test strips. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 | ||||||||||||||||||
65 | IVD 0401 | Clinical chemistry | Glucose analyzers, electrolyte analyzers, and lipid profile kits. | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 19 | |||||||||||
66 | IVD 0402 | Hematology | Hemoglobin meters, hematocrit analyzers, automated blood cell counters. | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 9 | |||||||||||||||||||
67 | IVD 0403 | Immunology | Rapid antigen test kits for infectious diseases, immunoassay kits for specific antibodies (e.g., ANA tests). | 4 | 1 | 2 | 1 | 4 | 1 | 2 | 1 | 1 | 1 | 3 | 21 | |||||||||||||||
68 | IVD 0404 | Molecular biology | PCR-based diagnostic kits, nucleic acid extraction kits, gene expression panels. | 1 | 1 | 1 | 2 | 4 | 1 | 1 | 3 | 2 | 1 | 1 | 1 | 2 | 21 | |||||||||||||
69 | IVD 0405 | Pregnancy and ovulation | Home pregnancy test kits, ovulation predictor kits based on luteinizing hormone (LH) levels. | 1 | 2 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 14 | ||||||||||||||||
70 | IVD 0406 | Specimen receptacles | Urine collection cups, blood sample tubes, sterile swabs for specimen collection. | 1 | 2 | 1 | 2 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 3 | 19 | ||||||||||||||
71 | MDS 7001 | Medical devices incorporating medicinal substances, according to Directive 2001/83/EC | Drug-eluting stents, wound dressings with antimicrobial agents like silver or iodine. | 1 | 1 | 2 | ||||||||||||||||||||||||
72 | MDS 7002 | Medical devices utilizing tissues of animal origin, including Directive 2003/32/EC | Heart valve prostheses made from bovine or porcine tissue, collagen-based wound dressings. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
73 | MDS 7003 | Medical devices incorporating derives of human blood, according to Directive 2000/70/EC, amended by Directive 2001/104/EC | Fibrin sealants, albumin-coated surgical adhesives. | 1 | 1 | |||||||||||||||||||||||||
74 | MDS 7004 | Medical devices referencing the Directive 2006/42/EC on machinery | Robotic surgical systems, powered hospital beds with safety features. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
75 | MDS 7005 | Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) | Surgical masks, protective gowns, face shields. | 1 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 12 | |||||||||||||||||
76 | MDS 7206 | IVDs in sterile condition | Sterile swabs for microbiological sampling, single-use sterile blood culture bottles. | 1 | 1 | 1 | 3 | |||||||||||||||||||||||
77 | MDS 7207 | IVDs utilizing micromechanics | Microfluidic diagnostic chips, lab-on-a-chip devices for point-of-care testing. | 1 | 1 | |||||||||||||||||||||||||
78 | MDS 7208 | IVDs utilizing nanomaterials | Nanoparticle-based biosensors, quantum dot immunoassay kits. | 0 | ||||||||||||||||||||||||||
79 | MDS 7209 | IVDs utilizing biological active coating and/or material | Diagnostic assays with bio-functional coatings, enzyme-coated biosensors. | 0 | ||||||||||||||||||||||||||
80 | MDS 7210 | IVDs utilizing material of human origin | Human chorionic gonadotropin (hCG) test kits, immunoassays employing human-derived reagents. | 1 | 1 | 2 | ||||||||||||||||||||||||
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