Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 24th July, 2018.

I, SHANE ROSS, Minister for Transport, Tourism and Sport, in exercise of the powers conferred on me by section 42 (2) of the Road Traffic Act 1961 (No. 4 of 1961) and section 2 of the Road Traffic Act 2006 (No. 23 of 2006), for the purpose of giving effect to Commission Directive No. 2016/1106/EU of 7 July 2016¹ , hereby make the following regulations:

1. These Regulations may be cited as European Union (Licensing of Drivers) Regulations 2018.

2. In these Regulations—

“Principal Regulations” means the Road Traffic (Licensing of Drivers) Regulations 2006 ( S.I. No. 537 of 2006 );

“Regulations of 2010” means the Road Traffic (Licensing of Drivers) (Amendment) (No. 2) Regulations 2010 ( S.I. No. 544 of 2010 ).

3. The Principal Regulations are amended in Part 2 of Schedule 6, as substituted by the Regulations of 2010, by substituting—

(a) for paragraph 4, the following

“Cardiovascular Diseases.

4. (1) Cardiovascular conditions or diseases can lead to a sudden impairment of the cerebral functions that constitutes a danger to road safety. These conditions represent grounds for establishing temporary or permanent restrictions to driving.

(2) For the following cardiovascular conditions, driving licences and learner permits may be issued or renewed for applicants or drivers in the indicated categories, only after the condition has been effectively treated and subject to competent medical authorisation and if appropriate, regular medical assessment:

(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 categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(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 categories C, CE, C1, C1E, D, DE, D1 and D1E);

(c) tachy-arrhythmias (supraventricular and ventricular arrhythmias) with

— structural heart disease and sustained ventricular tachycardia (VT) (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E), or

— polymorphic nonsustained VT, sustained ventricular tachycardia or with an indication for a defibrillator (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(d) symptomatic of angina (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(e) permanent pacemaker implantation or replacement (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(f) defibrillator implantation or replacement or appropriate or inappropriate defibrillator shock (applies to categories A, A1, A2, AM, B, B1 and BE);

(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 categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(h) acute coronary syndrome (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(i) stable angina if symptoms do not occur with mild exercise (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(j) percutaneous coronary intervention (PCI) (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(k) coronary artery bypass graft surgery (CABG) (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(l) stroke/transient ischemic attack (TIA) (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(m) significant carotid artery stenosis (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(n) maximum aortic diameter exceeding 5.5 cm (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(o) heart failure:

— New York Heart Association (NYHA) I, II, III (applies to categories A, A1, A2, AM, B, B1 and BE),

— NYHA I and II provided that the left ventricular ejection fraction is at least 35 % (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(p) heart transplantation (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(q) cardiac assist device (applies to categories A, A1, A2, AM, B, B1 and BE);

(r) valvular heart surgery (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(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 categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(t) grade III blood pressure (diastolic blood pressure ≥ 110 mmHg and/or systolic blood pressure ≥ 180 mmHg) (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(u) congenital heart disease (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(v) hypertrophic cardiomyopathy if without syncope (applies to categories A, A1, A2, AM, B, B1 and BE);

(w) long QT syndrome with syncope, Torsade des Pointes or QTc > 500 ms (applies to categories A, A1, A2, AM, B, B1 and BE).

(3) For the following cardiovascular conditions, subject to the final paragraph of this subsection, driving licences and learner permits shall not be issued or renewed for applicants or drivers in the indicated categories:

(a) implant of a defibrillator (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(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 categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E);

(c) heart failure:

— NYHA IV (applies to categories A, A1, A2, AM, B, B1 and BE),

— NYHA III and IV (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(d) cardiac assist devices (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(e) valvular heart disease with aortic regurgitation, aortic stenosis, mitral regurgitation or mitral stenosis if functional ability is estimated to be NYHA IV or if there have been syncopal episodes (applies to categories A, A1, A2, AM, B, B1 and BE);

(f) valvular heart disease in NYHA 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 categories C, CE, C1, C1E, D, DE, D1 and D1E);

(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 categories C, CE, C1, C1E, D, DE, D1 and D1E);

(h) long QT syndrome with syncope, Torsade des Pointes and QTc > 500 ms (applies to categories C, CE, C1, C1E, D, DE, D1 and D1E);

(i) Brugada syndrome with syncope or aborted sudden cardiac death (applies to categories A, A1, A2, AM, B, B1, BE, C, CE, C1, C1E, D, DE, D1 and D1E).

Driving licences and learner permits may be issued or renewed in exceptional cases, provided that it is duly justified by competent medical opinion and subject to regular medical assessment ensuring that the person is still capable of driving the vehicle safely taking into account the effects of the medical condition.

(4) Other cardiomyopathies

The risk of sudden incapacitating events shall be evaluated in applicants or drivers with well described cardiomyopathies (e.g. 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. This should be done by a cardiologist.

(5) The issue or renewal of driving licences or learner permits for applicants or drivers with other cardiovascular diseases may be restricted.”;

and

(b) for subparagraph 5(2), the following

“(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 and learner permits shall not be issued to, or renewed for, applicants or drivers who have inadequate awareness of hypoglycaemia.

Driving licences and learner permits shall not be issued to, or renewed for, applicants or drivers who have recurrent severe hypoglycaemia, unless supported by competent medical opinion and regular medical assessment. For recurrent severe hypoglycaemias during waking hours a licence or permit shall not be issued or renewed until 3 months after the most recent episode.

Driving licences and learner permits may be issued or renewed in exceptional cases, provided that it is duly justified by competent medical opinion and subject to regular medical assessment, ensuring that the person is still capable of driving the vehicle safely taking into account the effects of the medical condition.”

GIVEN under my Official Seal,

19 July 2018.

SHANE ROSS,

Minister for Transport, Tourism and Sport.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations amend the medical criteria for certification of fitness to drive, in order to give effect to Commission Directive No. 2016/1106/EU of 7 July 2016.

1 OJ L183, 08.07.2016, p.59