Annex III — MINIMUM STANDARDS OF FITNESS FOR DRIVING A POWER-DRIVEN VEHICLE

DEFINITIONS 1. For the purpose of this Annex, drivers shall be classified in two groups: Group 1: drivers of vehicles of categories A, A1, A2, AM, B, B1 and BE; Group 2: drivers of vehicles of categories C, CE, C1, C1E, D, DE, D1 and D1E. National law may provide that the requirements set out in this Annex for Group 2 drivers shall also apply to drivers of category B vehicles using their driving licence for professional purposes (taxis, ambulances, etc.). 2. Applicants for a first driving licence or for the renewal of a driving licence shall be classified in the group to which they will belong if the driving licence applied for has been issued or renewed. Title 1 EYESIGHT 3. All applicants for a driving licence shall undergo an appropriate assessment to ensure that they have adequate visual acuity for driving power-driven vehicles, and to establish if further examination of their field of vision is needed. Where there is reason to doubt that the applicant’s vision is adequate, he or she should be examined by a competent professional authorised by national law. At that examination, attention shall be paid, in particular, to the following: visual acuity, field of vision, twilight vision, glare and contrast sensitivity, diplopia and other visual functions that can compromise safe driving. For Group 1 drivers, licensing may be considered in exceptional individual cases where the visual field standard or visual acuity standard cannot be met, but there are reasons to believe that issuing a driving licence to the applicant would not impair road safety; in such cases, the driver shall undergo examination by a competent professional authorised by national law, in order to demonstrate that there is no other impairment of visual function, including glare, contrast sensitivity and twilight vision. The driver or applicant should also be subject to a positive practical test conducted by a competent authority. Group 1: (1) Applicants for a driving licence or for the renewal of such a driving licence shall have a binocular visual acuity, with corrective lenses if necessary, of at least 0,5 when using both eyes together. Moreover, the horizontal visual field shall be at least 120 degrees, the extension shall be at least 50 degrees left and right and 20 degrees up and down. No defects shall be present within a radius of the central 20 degrees. When a progressive eye disease is detected or declared, driving licences may be issued or renewed subject to the applicant undergoing regular examination by a competent professional authorised by national law. (2) Applicants for a driving licence, or for the renewal of a driving licence, who have total functional loss of vision in one eye, or who use only one eye (for instance in the case of diplopia) shall have a visual acuity of at least 0,5, with corrective lenses if necessary. The competent professional authorised by national law shall certify that this condition of monocular vision has existed for a time sufficiently long to allow adaptation, and that the field of vision in this eye meets the requirement laid down in point 3.(1). (3) After any recently developed diplopia, or after the loss of vision in one eye, there shall be an appropriate adaptation period, for example, six months, during which driving is not allowed. After that period, driving shall be allowed only following a favourable opinion from vision and driving experts, and may be subject to certain requirements or restrictions. Group 2: (4) Applicants for a driving licence or for the renewal of a driving licence shall have a visual acuity, with corrective lenses if necessary, of at least 0,8 in the better eye, and at least 0,1 in the worse eye. If corrective lenses are used to attain the values of 0,8 and 0,1, the minimum acuity (0,8 and 0,1) shall be achieved either by correction by means of glasses with a power not exceeding plus eight dioptres, or with the aid of contact lenses. The correction must be well tolerated. Moreover, the horizontal visual field with both eyes shall be at least 160 degrees, the extension shall be at least 70 degrees left and right and 30 degrees up and down. No defects shall be present within a radius of the central 30 degrees. Driving licences shall not be issued to or renewed for applicants or drivers with impaired contrast sensitivity or with diplopia. After a substantial loss of vision in one eye, there shall be an appropriate adaptation period, for example six months, during which the subject is not allowed to drive. After this period, driving shall be allowed only after a favourable opinion from vision and driving experts, and may be subject to certain requirements or restrictions. Title 2 HEARING 4. Driving licences may be issued to or renewed for applicants or drivers in Group 2 with a hearing impairment subject to an opinion being given by the competent medical authorities based on a medical examination which shall take particular account of the scope for compensation. Title 3 PERSONS WITH A PHYSICAL DISABILITY 5. Driving licences shall not be issued to, or renewed for, applicants or drivers with complaints or impairments of the locomotor system which make it dangerous to drive a power-driven vehicle. Group 1: (1) Driving licences subject to certain restrictions may be issued to applicants or drivers with physical disabilities following an opinion by a competent medical authority. That opinion shall be based on a medical assessment of the complaint or impairment in question and, where necessary, on a practical test. It shall also indicate what type of modification to the vehicle is required and whether the driver needs to use an orthopaedic device, insofar as a test of skills and behaviour demonstrates that with such a device driving would not be dangerous. (2) Driving licences may be issued to, or renewed for, any applicant or driver with a progressive complaint on condition that the person be examined regularly to ensure that the person is still capable of driving the vehicle completely safely. Where the physical disability is static, driving licences may be issued or renewed without the applicant being subject to regular medical examination. Group 2: (3) The competent medical authority shall give due consideration to the additional risks and dangers involved in the driving of vehicles covered by the definition of this Group. Title 4 CARDIOVASCULAR DISEASES 6. Cardiovascular conditions or diseases can lead to a sudden impairment of the cerebral functions that constitutes a danger to road safety. Those conditions represent grounds for establishing temporary or permanent restrictions to driving. (1) For the following cardiovascular conditions, driving licences may be issued or renewed for applicants or drivers in the indicated groups, only after the condition has been effectively treated and subject to authorization by and, if appropriate, regular medical assessment by, a competent medical authority: (a) brady-arrhythmias (sinus node disease and conduction disturbances) and tachy-arrhythmias (supraventricular and ventricular arrhythmias) with history of syncope or syncopal episodes due to arrhythmic conditions (applies to Groups 1 and 2); (b) brady-arrhythmias: sinus node disease and conduction disturbances with second degree atrioventricular (AV) block Mobitz II, third degree AV block or alternating bundle branch block (applies to Group 2 only); (c) tachy-arrhythmias (supraventricular and ventricular arrhythmias) with (i) structural heart disease, especially sustained ventricular tachycardia (VT) (applies to Groups 1 and 2); or (ii) polymorphic non-sustained VT or with an indication for a defibrillator (applies to Group 2 only); (d) symptomatic of angina (applies to Groups 1 and 2); (e) permanent pacemaker implantation or replacement (applies to Group 2 only); (f) defibrillator implantation or replacement, or appropriate or inappropriate defibrillator shock (applies to Group 1 only); (g) syncope (a transient loss of consciousness and postural tone, characterised by rapid onset, short duration, and spontaneous recovery, due to global cerebral hypoperfusion, of presumed reflex origin, of unknown cause, with no evidence of underlying heart disease) (applies to Groups 1 and 2); (h) acute coronary syndrome (applies to Groups 1 and 2); (i) stable angina if symptoms do not occur with mild exercise (applies to Groups 1 and 2); (j) percutaneous coronary intervention (PCI) (applies to Groups 1 and 2); (k) coronary artery bypass graft surgery (CABG) (applies to Groups 1 and 2); (l) stroke or transient ischemic attack (TIA) (applies to Groups 1 and 2); (m) significant carotid artery stenosis (applies to Group 2 only); (n) maximum aortic diameter exceeding 5,5 cm (applies to Group 2 only); (o) heart failure: (i) New York Heart Association (NYHA) Class I, II and III (applies to Group 1 only); (ii) NYHA Class I and II, provided that the left ventricular ejection fraction is at least 35 % (applies to Group 2 only); (p) heart transplantation (applies to Groups 1 and 2); (q) cardiac assist device (applies to Group 1 only); (r) valvular heart surgery (applies to Groups 1 and 2); (s) malignant hypertension (elevation in systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg associated with impending or progressive organ damage) (applies to Groups 1 and 2); (t) grade III blood pressure (diastolic blood pressure ≥ 110 mmHg and/or systolic blood pressure ≥ 180 mmHg) (applies to Group 2 only); (u) congenital heart disease (applies to Groups 1 and 2); (v) hypertrophic cardiomyopathy if without syncope (applies to Group 1 only); (w) long QT syndrome with syncope, Torsade des Pointes or QTc > 500 ms (applies to Group 1 only). (2) For the following cardiovascular conditions, driving licences shall not be issued or renewed for applicants or drivers in the indicated groups: (a) implant of a defibrillator (applies to Group 2 only); (b) peripheral vascular disease – thoracic and abdominal aortic aneurysm when maximum aortic diameter is such that it predisposes to a significant risk of sudden rupture and hence a sudden disabling event (applies to Groups 1 and 2); (c) heart failure: (i) NYHA Class IV (applies to Group 1 only); (ii) NYHA Class III and IV (applies to Group 2 only); (d) cardiac assist devices (applies to Group 2 only); (e) valvular heart disease with aortic regurgitation, aortic stenosis, mitral regurgitation or mitral stenosis if functional ability is estimated to be NYHA Class IV or if there have been syncopal episodes (applies to Group 1 only); (f) valvular heart disease in NYHA Class III or IV, or with ejection fraction (EF) below 35 %, mitral stenosis and severe pulmonary hypertension or with severe echocardiographic aortic stenosis or aortic stenosis causing syncope; except for completely asymptomatic severe aortic stenosis if the exercise tolerance test requirements are fulfilled (applies to Group 2 only); (g) structural and electrical cardiomyopathies – hypertrophic cardiomyopathy with history of syncope or when two or more of the following conditions present: left ventricle (LV) wall thickness > 3 cm, non-sustained ventricular tachycardia, a family history of sudden death (in a first degree relative), no increase of blood pressure with exercise (applies to Group 2 only); (h) long QT syndrome with syncope, Torsade des Pointes and QTc > 500 ms (applies to Group 2 only); (i) Brugada syndrome with syncope or aborted sudden cardiac death (applies to Groups 1 and 2). Driving licences may be issued or renewed in exceptional cases, provided that it is duly justified by a medical opinion of, and subject to regular medical assessment by, a competent medical authority, ensuring that the person is still capable of driving the vehicle safely taking into account the effects of the medical condition. (3) Other cardiomyopathies The risk of sudden incapacitating events shall be evaluated in applicants or drivers with well described cardiomyopathies (for instance arrhythmogenic right ventricular cardiomyopathy, non-compaction cardiomyopathy, catecholaminergic polymorphic ventricular tachycardia and short QT syndrome) or with new cardiomyopathies that may be discovered. A careful specialist evaluation is required. The prognostic features of the particular cardiomyopathy shall be considered. (4) Member States may restrict the issue or renewal of driving licences for applicants or drivers with other cardiovascular diseases. Title 5 DIABETES MELLITUS 7. For the purpose of the following points, the following definitions apply: severe hypoglycaemia means where the assistance of another person is needed; recurrent severe hypoglycaemia means a second episode of severe hypoglycaemia during a period of 12 months. Group 1: (1) Driving licences may be issued to, or renewed for, applicants or drivers who have diabetes mellitus. When treated with medication with a low hypoglycaemia risk, they shall be subject to regular medical review by a competent medical authority, appropriate to each case. When treated with medication with a high hypoglycaemia risk which can have consequences for their fitness to drive, they shall be subject to a medical opinion by a competent and authorised medical professional and regular medical review, appropriate to each case, but the interval shall not exceed ten years. (2) An applicant or driver with diabetes treated with medication which carries a risk of inducing hypoglycaemia shall demonstrate an understanding of the risk of hypoglycaemia and adequate control of the condition. Driving licences shall not be issued to, or renewed for, applicants or drivers who have inadequate awareness of hypoglycaemia. Driving licences shall not be issued to, or renewed for, applicants or drivers who have recurrent severe hypoglycaemia, unless supported by a medical opinion of, and regular medical assessment by, a competent medical authority. For recurrent severe hypoglycaemias during waking hours, a driving licence shall not be issued or renewed until three months after the most recent episode. Driving licences may be issued or renewed in exceptional cases, provided that it is duly justified by a medical opinion of, and subject to regular medical assessment by, a competent medical authority, ensuring that the person is still capable of driving the vehicle safely taking into account the effects of the medical condition. Group 2: (3) Consideration may be given to the issuing or renewal of Group 2 driving licences to applicants or drivers with diabetes mellitus. When treated with medication which carries a risk of inducing hypoglycaemia, that is with insulin and some tablets, the following criteria shall apply: (a) no severe hypoglycaemic events have occurred in the previous 12 months; (b) the driver has full hypoglycaemic awareness; (c) the driver must be able to perform adequate control of the blood glucose levels by regular controls, using technical aids, at least twice daily and at times relevant to driving; (d) the driver must demonstrate an understanding of the risks of hypoglycaemia; (e) there are no other debarring complications of diabetes. Moreover, in those cases, such driving licences shall be issued or renewed subject to the positive opinion of, and to regular medical review by, a competent medical authority, undertaken at intervals of not more than three years. (4) A severe hypoglycaemic event during waking hours, even unrelated to driving, shall be reported and shall give rise to a reassessment of the licensing status. Title 6 NEUROLOGICAL DISEASES AND OBSTRUCTIVE SLEEP APNOEA SYNDROME 8. The following rules apply to applicants with neurological diseases and obstructive sleep apnoea syndrome. Title 7 NEUROLOGICAL DISEASES (1) Driving licences shall not be issued to, or renewed for, applicants or drivers with a serious neurological disease, unless the application is supported by a positive medical opinion of a competent and authorised medical professional. Neurological disturbances associated with developmental conditions, diseases, medical or surgical intervention affecting the central or peripheral nervous system, which lead to cognitive, behavioural, sensory or motor impairments and affect performance or function, balance and coordination, shall be taken into account accordingly in relation to their functional effects on driving. The risks of progression of impairment and lack of compliance with treatment need to be taken into account. In such cases, the issue or renewal of the driving licence may be subject to periodic assessment in the event of risk of deterioration. Title 8 OBSTRUCTIVE SLEEP APNOEA SYNDROME (2) For the purpose of the following points: moderate obstructive sleep apnoea syndrome means a number of apnoeas and hypopnoeas per hour (Apnoea-Hypopnoea Index) between 15 and 29; severe obstructive sleep apnoea syndrome means an Apnoea-Hypopnoea Index of 30 or more, both associated with excessive daytime sleepiness. (3) Applicants or drivers in whom a moderate or severe obstructive sleep apnoea syndrome is suspected shall be referred for further medical advice by a competent and authorised medical professional before a driving licence is issued or renewed. They may be advised not to drive until confirmation of the diagnosis. (4) Driving licences may be issued to applicants or drivers with moderate or severe obstructive sleep apnoea syndrome who show adequate control of their condition and compliance with appropriate treatment and improvement of sleepiness, if any, confirmed by a medical opinion of a competent and authorised medical professional. (5) Applicants or drivers with moderate or severe obstructive sleep apnoea syndrome under treatment shall be subject to a periodic medical review, at intervals not exceeding three years for drivers of Group 1 and one year for drivers of Group 2, with a view to establishing their level of compliance with the treatment, the need for continuing the treatment and continued good vigilance. Title 9 EPILEPSY 9. Epileptic seizures or other sudden disturbances of the state of consciousness constitute a serious danger to road safety if they occur in a person driving a power-driven vehicle. For the purpose of the following points: epilepsy means a medical condition in which the person concerned has had two or more epileptic seizures, less than five years apart; provoked epileptic seizure means a seizure which has a recognisable causative factor that is avoidable. A person who has an initial or isolated seizure or loss of consciousness shall be advised not to drive. A specialist report is required, stating the period of driving prohibition and the requested follow-up. It is extremely important that the person’s specific epilepsy syndrome and seizure type be identified so that a proper evaluation of the person’s driving safety can be undertaken, including the risk of further seizures, and the appropriate therapy instituted. This shall be done by a neurologist. Group 1: (1) Drivers assessed under Group 1 with epilepsy shall be under driving licence review until they have been seizure-free for at least five years. If the applicant or driver has epilepsy and until he or she has been seizure-free for at least five years, the criteria for an unconditional driving licence shall not be deemed to be met. (2) Provoked epileptic seizure: the applicant having had such a condition because of a recognisable provoking factor that is unlikely to recur at the wheel may be declared able to drive on an individual basis, subject to neurological opinion. If appropriate, the assessment shall be in accordance with other relevant Titles, for instance in the case of alcohol or other co-morbidity. (3) First or single unprovoked seizure: the applicant or driver who has had a first unprovoked epileptic seizure may be declared able to drive after a period of six months without seizures, if there has been an appropriate medical assessment. National authorities may allow applicants or drivers with recognised good prognostic indicators to drive sooner. (4) Other loss of consciousness: the loss of consciousness shall be assessed according to the risk of recurrence while driving. (5) Epilepsy: applicants or drivers may be declared fit to drive after a one-year period free of further seizures. (6) Seizures exclusively in sleep: the applicant or driver who has never had any seizures other than seizures during sleep may be declared fit to drive so long as this pattern has been established for a period which must not be less than the seizure-free period required for epilepsy. If there is an occurrence of attacks or seizures arising while awake, a one-year period free of any further event before licensing is required. (7) Seizures without influence on consciousness or the ability to act: the applicant or driver who has never had any seizures other than seizures which have been demonstrated exclusively to affect neither consciousness nor to cause any functional impairment may be declared fit to drive if this pattern has been established for a period which shall not be less than the seizure-free period required for epilepsy. If there is an occurrence of any other kind of attacks or /seizures, a one-year period free of any further event before licensing is required. (8) Seizures because of a physician-directed change or reduction of anti-epileptic therapy: the patient may be advised not to drive from the commencement of the period of withdrawal and thereafter for a period of six months after cessation of treatment. Seizures occurring during physician-advised change or withdrawal of medication require three months off driving if the previously-effective treatment is reinstated. (9) After curative epilepsy surgery drivers or applicants may be declared fit to drive after a one-year period free of further seizures. Group 2: (10) The applicant or driver shall be without anti-epileptic medication for the required period of seizure freedom. An appropriate medical follow-up shall have been carried out. Extensive neurological investigation shall have shown that there is neither a relevant cerebral pathology nor any epileptiform activity on the electroencephalogram (EEG). An EEG and an appropriate neurological assessment shall be performed after the acute episode. (11) In the case of a provoked epileptic seizure, due to an identifiable causative factor, a favourable neurological report must be provided, certifying a seizure-free period of at least one year and including an electroencephalographic assessment. Other Titles shall be taken into account. In case of structural brain lesions with increased risk for the onset of epileptic seizures, their magnitude shall be assessed by means of a neurological report. (12) First or single unprovoked seizure: the applicant or driver who has had a first unprovoked epileptic seizure may be declared able to drive once five years’ freedom from further seizures has been achieved without the aid of anti-epileptic drugs, if there has been an appropriate neurological assessment. The medical authorities may allow an applicant or driver with recognised good prognostic indicators to drive sooner. (13) Other loss of consciousness: the loss of consciousness shall be assessed according to the risk of recurrence while driving. (14) Epilepsy: 10 years freedom from further seizures shall have been achieved without the aid of anti-epileptic drugs. National authorities may allow applicants or drivers with recognised good prognostic indicators to drive sooner. This shall also apply in case of juvenile epilepsy. Certain disorders, for instance arteriovenous malformation or intra-cerebral haemorrhage, entail an increased risk of seizures, even if seizures have not yet occurred. In such a situation an assessment shall be carried out by a competent medical authority. Title 10 MENTAL IMPAIRMENTS 10. The following rules apply to applicants or drivers with mental or intellectual impairment. Group 1: (1) Driving licences shall not be issued to, or renewed for, applicants or drivers with: (a) severe mental, cognitive or behavioural impairment, whether congenital or due to disease, trauma or neurosurgical operations; (b) personality impairments leading to seriously impaired judgment, behaviour or adaptability, unless their application is supported by a medical opinion of a competent and authorised medical professional and, if necessary, subject to regular medical check-ups. A prior period of remission should be observed. Group 2: (2) The competent medical authority shall give due consideration to the additional risks and dangers involved in the driving of vehicles covered by the definition of this Group. The competent medical authority may establish temporary requirements or impose restrictions on driving. Title 11 ALCOHOL 11. Alcohol consumption constitutes a major danger to road safety. In view of the scale of the problem, the medical profession must be very vigilant. Group 1: (1) Driving licences shall not be issued to, or renewed for, applicants or drivers who are dependent on alcohol, or who are unable to refrain from drinking and driving. After a proven period of abstinence, driving licences may be issued or renewed if the applicant or driver is the subject of a positive medical opinion of a competent and authorised medical professional and a period of regular medical check-ups. (2) Driving licences may be issued to, or renewed for, applicants or drivers who are dependent on alcohol or unable to refrain from drinking and driving provided that technologies enabling to offset the dependency, for example, the mandatory use of an alcohol interlock, are used, and provided that the driver is subject to periodic review of further treatment to address dependence or lack of dissociation of drinking from driving. If a period of abstinence is proven, which may include participation in rehabilitation programmes with monitoring and medical supervision, driving licences may be issued or renewed without use of such technologies if the driver is subject to a medical opinion of a competent and authorised medical professional and a period of regular medical check-ups. The regular medical check-ups may be performed during or after the use of such technologies, or both. Group 2: (3) The competent medical authority shall give due consideration to the additional risks and dangers involved in the driving of vehicles covered by the definition of this group. (4) The competent medical authority may establish temporary requirements and, where appropriate, restrictions on driving. Title 12 DRUGS AND MEDICINAL PRODUCTS 12. The following rules apply to drugs and medical products. Abuse: (1) Driving licences shall not be issued to, or renewed for, applicants or drivers who are dependent on psychotropic substances or narcotics, or who are not dependent on such substances but are not willing or unable to dissociate consumption from driving, whatever category of driving licence is requested. Regular use: Group 1: (2) Driving licences shall not be issued to, or renewed for, applicants or drivers who regularly use psychotropic substances or narcotics, in whatever form, which can hamper the ability to drive safely, where the quantities absorbed are such as to have an adverse effect on driving. This shall apply to all other medicinal products or combinations of medicinal products which hamper the mental or physical ability to drive. The competent medical authority may establish temporary requirements and, where appropriate, restrictions on driving. Group 2: (3) The competent medical authority shall give due consideration to the additional risks and dangers involved in the driving of vehicles covered by the definition of this group and may establish certain requirements or restrictions. Title 13 RENAL DISORDERS 13. The following rules apply to applicants with renal disorders. Group 1: (1) Driving licences may be issued to, or renewed for, applicants and drivers with serious renal insufficiency and resulting significant limitation of physical capacity subject to a medical opinion of a competent and authorised medical professional and regular medical check-ups. Group 2: (2) Save in exceptional cases duly justified by a medical opinion of a competent and authorised medical professional and subject to regular medical check-ups, driving licences shall not be issued to, or renewed for, applicants or drivers with serious and irreversible renal deficiency. Title 14 MISCELLANEOUS PROVISIONS Group 1: (1) Subject to a medical opinion of a competent and authorised medical professional and, if necessary, regular medical check-ups, driving licences may be issued to, or renewed for, applicants or drivers who have had an organ transplant or an artificial implant which affects the ability to drive. Group 2: (2) The competent medical authority shall give due consideration to the additional risks and dangers involved in the driving of vehicles covered by the definition of this Group. As a general rule, where applicants or drivers have any disorder which is not mentioned in this Annex but is liable to be, or to result in, a functional incapacity affecting driving safety, driving licences shall not be issued or renewed unless the application is supported by a medical opinion of a competent and authorised medical professional and, if necessary, the applicant or driver is subject to regular medical check-ups.