MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

Regulation (EU) 2019/27

(a) An applicant for a LAPL medical certificate shall be assessed based on aero-medical best practice.

(b) Special attention shall be given to the applicant’s complete medical history.

(c) The initial assessment, all subsequent re-assessments after the licence holder reaches the age of 50 and any assessments in cases where the medical history of the applicant is not available to the examiner shall include at least all of the following:

(1) clinical examination;

(2) blood pressure;

(3) urine test;

(4) vision;

(5) hearing ability.

(d) After the initial assessment, subsequent re-assessments until the licence holder reaches the age of 50 shall include at least both of the following:

(1) an assessment of the LAPL holder's medical history;

(2) the items specified in point(c) as deemed necessary by the AeMC, AME or GMP in accordance with aero-medical best practice.

AMC1 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

When a specialist evaluation is required under this section, the aero-medical assessment of the applicant should be performed by an AeMC, an AME or, in the case of AMC5 MED.B.095(d), by the medical assessor of the licensing authority.

AMC2 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

CARDIOVASCULAR SYSTEM

(a) Examination

Pulse and blood pressure should be recorded at each examination.

(b) General

(1) Cardiovascular risk factor assessment

An accumulation of risk factors (smoking, family history, lipid abnormalities, hypertension, etc.) requires cardiovascular evaluation.

(2) Aortic aneurysm

Applicants with an aortic aneurysm may be assessed as fit subject to satisfactory cardiological evaluation and a regular follow-up.

(3) Cardiac valvular abnormalities

(i) Applicants with a cardiac murmur may be assessed as fit if the murmur is assessed as being of no pathological significance.

(ii) Applicants with a cardiac valvular abnormality may be assessed as fit subject to satisfactory cardiological evaluation.

(4) Valvular surgery

After cardiac valve replacement or repair, a fit assessment may be considered, with an ORL if anticoagulation is needed, subject to satisfactory post-operative cardiological evaluation. Anticoagulation should be stable and the haemorrhagic risk should be acceptable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. The INR target range should be determined by the type of surgery performed. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence if the INR is within the target range, may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(5) Other cardiac disorders

(i) Applicants with other cardiac disorders may be assessed as fit subject to satisfactory cardiological evaluation. A fit assessment may be considered, with an ORL if anticoagulation is needed. Anticoagulation should be stable and the haemorrhagic risk should be acceptable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. The INR target range should be determined by the type of surgery performed. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence if the INR is within the target range, may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(ii) Applicants with symptomatic hypertrophic cardiomyopathy should be assessed as unfit.

(c) Blood pressure

(1) When the blood pressure consistently exceeds 160 mmHg systolic and/or 95 mmHg diastolic, with or without treatment, the applicant should be assessed as unfit.

(2) Applicants initiating medication for the control of blood pressure should be assessed as unfit until the absence of significant side effects has been established.

(d) Coronary artery disease

(1) Applicants with suspected myocardial ischaemia should undergo a cardiological evaluation before a fit assessment may be considered.

(2) Applicants with angina pectoris requiring medication for cardiac symptoms should be assessed as unfit.

(3) After an ischaemic cardiac event, including myocardial infarction or revascularisation, applicants without symptoms should have reduced cardiovascular risk factors to an appropriate level. Medication, when used to control cardiac symptoms, is not acceptable. All applicants should be on appropriate secondary prevention treatment.

(4) In cases (d)(1), (d)(2) and (d)(3), applicants who have had a satisfactory cardiological evaluation to include an exercise test or equivalent that is negative for ischaemia may be assessed as fit.

(e) Rhythm and conduction disturbances

(1) Applicants with a significant disturbance of cardiac rhythm or conduction should be assessed as unfit unless a cardiological evaluation concludes that the disturbance is not likely to interfere with the safe exercise of the privileges of the licence. A fit assessment may be considered, with an ORL if anticoagulation is needed. Anticoagulation should be stable and the haemorrhagic risk should be acceptable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. The INR target range should be determined by the type of surgery performed. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence if the INR is within the target range, may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(2) Pre-excitation

Applicants with ventricular pre-excitation may be assessed as fit subject to satisfactory cardiological evaluation. Applicants with ventricular pre-excitation associated with a significant arrhythmia should be assessed as unfit.

(3) Automatic implantable defibrillating system

Applicants with an automatic implantable defibrillating system should be assessed as unfit.

(4) Pacemaker

A fit assessment may be considered subject to satisfactory cardiological evaluation.

AMC3 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

RESPIRATORY SYSTEM

(a) Applicants should undergo pulmonary morphological or functional tests when clinically indicated.

(b) Asthma and chronic obstructive pulmonary disease

Applicants with asthma or impairment of pulmonary function may be assessed as fit provided that the condition is considered stable with satisfactory pulmonary function and medication is compatible with flight safety. Systemic steroids may be acceptable provided that the dosage required is acceptable and there are no adverse side effects.

(c) Sarcoidosis

(1) Applicants with active sarcoidosis should be assessed as unfit. Investigation should be undertaken with respect to the possibility of systemic involvement. A fit assessment may be considered once the disease is inactive.

(2) Applicants with cardiac sarcoidosis should be assessed as unfit.

(d) Pneumothorax

(1) Applicants with spontaneous pneumothorax may be assessed as fit subject to satisfactory respiratory evaluation following recovery from a single spontaneous pneumothorax or following recovery from surgical intervention for a recurrent pneumothorax.

(2) Applicants with traumatic pneumothorax may be assessed as fit following recovery.

(e) Thoracic surgery

Applicants who have undergone thoracic surgery may be assessed as fit following recovery.

(f) Sleep apnoea syndrome/sleep disorder

Applicants with unsatisfactorily treated sleep apnoea syndrome should be assessed as unfit.

AMC4 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

DIGESTIVE SYSTEM

(a) Gallstones

Applicants with symptomatic gallstones should be assessed as unfit. A fit assessment may be considered following gallstone removal.

(b) Inflammatory bowel disease

Applicants with an established diagnosis or history of chronic inflammatory bowel disease may be assessed as fit provided that the disease is stable and not likely to interfere with the safe exercise of the privileges of the licence.

(c) Peptic ulceration

Applicants with peptic ulceration may be assessed as fit subject to satisfactory gastroenterological evaluation.

(d) Digestive tract and abdominal surgery

Applicants who have undergone a surgical operation:

(1) for herniae; or

(2) on the digestive tract or its adnexa, including a total or partial excision or diversion of any of these organs,

should be assessed as unfit. A fit assessment may be considered if recovery is complete, the applicant is asymptomatic, and there is only a minimal risk of secondary complication or recurrence.

(e) Pancreatitis

Applicants with pancreatitis may be assessed as fit after satisfactory recovery.

(f) Liver disease

Applicants with morphological or functional liver disease or after surgery, including liver transplantation, may be assessed as fit subject to satisfactory gastroenterological evaluation.

AMC5 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

METABOLIC AND ENDOCRINE SYSTEMS

(a) Metabolic, nutritional or endocrine dysfunction

Applicants with metabolic, nutritional or endocrine dysfunction may be assessed as fit subject to demonstrated stability of the condition and satisfactory aero-medical evaluation.

(b) Obesity

Obese applicants may be assessed as fit if the excess weight is not likely to interfere with the safe exercise of the licence.

(c) Thyroid dysfunction

Applicants with thyroid disease may be assessed as fit once a stable euthyroid state is attained.

(d) Diabetes mellitus

(1) Applicants using antidiabetic medications that are not likely to cause hypoglycaemia may be assessed as fit.

(2) Applicants with diabetes mellitus Type 1 should be assessed as unfit.

(3) Applicants with diabetes mellitus Type 2 treated with insulin may be assessed as fit with limitations for revalidation if blood sugar control has been achieved and the process under (e) and (f) is followed. An ORL is required. A TML for 12 months may be needed to ensure compliance with the follow-up requirements below. Licence privileges should not include rotary aircraft flying.

(e) Aero-medical assessment by, or under the guidance of, the medical assessor of the licensing authority:

(1) A diabetology review at yearly intervals, including:

(i) symptom review;

(ii) review of data logging of blood sugar;

(iii) cardiovascular status. Exercise ECG at age 40, at 5-yearly intervals thereafter and on clinical indication, including an accumulation of risk factors;

(iv) nephropathy status.

(2) Ophthalmological review at yearly intervals, including:

(i) visual fields — Humphrey-perimeter;

(ii) retinae — full dilatation slit lamp examination;

(iii) cataract — clinical screening.

The development of retinopathy requires a full ophthalmological review.

(3) Blood testing at 6-monthly intervals:

(i) HbA1c;

(ii) renal profile;

(iii) liver profile;

(iv) lipid profile.

(4) Applicants should be assessed as temporarily unfit after:

(i) changes of medication/insulin leading to a change to the testing regime until stable blood sugar control can be demonstrated;

(ii) a single unexplained episode of severe hypoglycaemia until stable blood sugar control can be demonstrated.

(5) Applicants should be assessed as unfit in the following cases:

(i) loss of hypoglycaemic awareness;

(ii) development of retinopathy with any visual field loss;

(iii) significant nephropathy;

(iv) any other complication of the disease where flight safety may be jeopardised.

(f) Pilot responsibility

Blood sugar testing is carried out during non-operational and operational periods. A whole blood glucose measuring device with memory should be carried and used. Equipment for continuous glucose monitoring (CGMS) should not be used. Pilots should prove to the AME or AeMC or medical assessor of the licensing authority that testing has been performed as indicated below and with which results.

(1) Testing during non-operational periods: normally 3–4 times/day or as recommended by the treating physician, and on any awareness of hypoglycaemia.

(2) Testing frequency during operational periods:

(i) 120 minutes before departure;

(ii) <30 minutes before departure;

(iii) 60 minutes during flight;

(iv) 30 minutes before landing.

(3) Actions following glucose testing:

(i) 120 minutes before departure: if the test result is >15 mmol/l, piloting should not be commenced.

(ii) 10–15g of carbohydrate should be ingested and a re-test performed within 30 minutes if:

(A) any test result is <4,5 mmol/l;

(B) the pre-landing test measurement is missed or a subsequent go-around/diversion is performed.

AMC6 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

HAEMATOLOGY

Applicants with a haematological condition, such as:

(a) abnormal haemoglobin including, but not limited to, anaemia, erythrocytosis or haemoglobinopathy;

(b) coagulation, haemorrhagic or thrombotic disorder;

(c) significant lymphatic enlargement;

(d) acute or chronic leukaemia;

(e) splenomegaly;

may be assessed as fit subject to satisfactory aero-medical evaluation. If anticoagulation is being used as treatment, refer to AMC2 MED.B.095(b)(4).

AMC7 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

GENITOURINARY SYSTEM

(a) Applicants with a genitourinary disorder, such as:

(1) renal disease; or

(2) one or more urinary calculi, or a history of renal colic

may be assessed as fit subject to satisfactory renal and urological evaluation, as applicable.

(b) Applicants who have undergone a major surgical operation on the genitourinary system or its adnexa may be assessed as fit following recovery.

(c) Applicants who have undergone renal transplantation may be assessed as fit subject to satisfactory renal evaluation.

AMC8 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

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AMC9 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

AMC10 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

AMC11 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

MENTAL HEALTH

(a) Applicants with a mental or behavioural disorder due to use or misuse of alcohol or other psychoactive substances, with or without dependency, should be assessed as unfit. A fit assessment may be considered after a period of two years of documented sobriety or freedom from psychoactive substance use or misuse, subject to satisfactory psychiatric evaluation after successful treatment. At revalidation or renewal, a fit assessment may be considered earlier. Depending on the individual case, treatment and evaluation may include in-patient treatment of some weeks followed by ongoing checks, including blood testing and peer reports, which may be required indefinitely.

(b) Applicants with a history of, or the occurrence of, a functional psychotic disorder should be assessed as unfit. A fit assessment may be considered if a cause can be unequivocally identified as one which is transient, has ceased, and the risk of recurrence is minimal.

(c) Applicants with an established history or clinical diagnosis of schizophrenia, schizotypal or delusional disorder should be assessed as unfit. A fit assessment may only be considered if the original diagnosis was inappropriate or inaccurate as confirmed by psychiatric evaluation or, in the case of a single episode of delirium, provided that the applicant has suffered no permanent impairment.

(d) Psychoactive substances

Applicants who use or misuse psychoactive substances or psychoactive medication likely to affect flight safety should be assessed as unfit. If stability on maintenance psychoactive medication is confirmed, a fit assessment with appropriate limitation(s) may be considered. If the dosage or type of medication is changed, a further period of unfit assessment should be required until stability is confirmed.

(e) Applicants with a psychiatric condition, such as:

(1) mood disorder;

(2) neurotic disorder;

(3) personality disorder;

(4) mental or behavioural disorder

should undergo satisfactory psychiatric evaluation before a fit assessment may be considered.

(f) Applicants with a history of significant or repeated acts of deliberate self-harm should undergo satisfactory psychiatric or psychological evaluation or both before a fit assessment may be considered.

(g) Psychiatric evaluations and reviews may include reports from the applicant’s flight instructor.

(h) Applicants with a psychological disorder may need to be referred for psychological opinion and advice.

(i) In case a specialist evaluation is needed, following the evaluation, the specialist should submit a written report to the AME, AeMC, GMP or medical assessor of the licensing authority as appropriate, detailing their opinion and recommendation.

AMC12 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

NEUROLOGY

(a) Epilepsy and seizures

(1) Applicants with an established diagnosis of and under treatment for epilepsy should be assessed as unfit. A re-assessment after all treatment has been stopped for at least 5 years should include a review of neurological reports.

(2) Applicants may be assessed as fit if:

(i) there is a history of a single afebrile epileptiform seizure considered to have a very low risk of recurrence;

(ii) there has been no recurrence after at least 5 years off treatment;

(iii) a cause has been identified and treated and there is no evidence of continuing predisposition to epilepsy.

(b) Neurological disease

Applicants with any disease of the nervous system which is likely to cause a hazard to flight safety should be assessed as unfit. However, in certain cases, including cases of functional loss associated with stable disease, a fit assessment may be considered after full evaluation including, if necessary, a medical flight test.

(c) Migraine

Applicants with an established diagnosis of migraine or other severe periodic headaches likely to cause a hazard to flight safety should be assessed as unfit. A fit assessment may be considered after full evaluation. The evaluation should take into account at least the following: auras, visual field loss, frequency, severity, therapy. Appropriate limitation(s) may apply.

(d) Head injury

Applicants with a head injury which was severe enough to cause loss of consciousness or is associated with penetrating brain injury may be assessed as fit if there has been a full recovery and the risk of epilepsy is sufficiently low. An evaluation by a neurologist may be required depending on the staging of the original injury.

(e) Spinal or peripheral nerve injury

Applicants with a history or diagnosis of spinal or peripheral nerve injury or a disorder of the nervous system due to a traumatic injury may be assessed as fit if neurological evaluation is satisfactory and the conditions of AMC10 MED.B.095 are satisfied.

(f) Vascular deficiencies

Applicants with a disorder of the nervous system due to vascular deficiencies including haemorrhagic and ischaemic events should be assessed as unfit. A fit assessment may be considered if neurological evaluation is satisfactory and the conditions of AMC10 MED.B.095 are satisfied. A cardiological evaluation and medical flight test should be undertaken for applicants with residual deficiencies.

AMC13 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

VISUAL SYSTEM

(a) Applicants should not possess any abnormality of the function of the eyes or their adnexa or any active pathological condition, congenital or acquired, acute or chronic, or any sequelae of eye surgery or trauma, which is likely to interfere with the safe exercise of the privileges of the applicable licence.

(b) Eye examination

The examination should include visual acuities (near, intermediate and distant vision) and visual field.

(c) Visual acuity

(1) Visual acuity with or without corrective lenses should be 6/9 (0,7) binocularly and 6/12 (0,5) in each eye.

(2) Applicants who do not meet the required visual acuity should be assessed by an AME or AeMC, taking into account the privileges of the licence held and the risk involved.

(3) Applicants should be able to read, binocularly, an N5 chart (or equivalent) at 30-50 cm and an N14 chart (or equivalent) at 100 cm, with correction if prescribed (Refer to GM1 MED.B.070).

(d) Visual acuity

Applicants with substandard vision in one eye may be assessed as fit if the better eye:

(1) achieves distant visual acuity of 6/6 (1,0), corrected or uncorrected;

(2) achieves distant visual acuity less than 6/6 (1,0) but not less than 6/9 (0,7), after ophthalmological evaluation.

(e) Visual field defects

Applicants with a visual field defect may be assessed as fit if the binocular visual field or, in the case of monocularity, the monocular visual field is acceptable.

(f) Eye surgery

(1) After refractive surgery, a fit assessment may be considered, provided that there is satisfactory stability of refraction, there are no post-operative complications and no significant increase in glare sensitivity.

(2) After cataract, retinal or glaucoma surgery a fit assessment may be considered once recovery is complete.

(g) Visual correction

Correcting lenses should permit the licence holder to meet the visual requirements at all distances.

AMC14 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

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AMC15 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

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OTORHINOLARYNGOLOGY (ENT)

(a) Hearing

(1) Applicants should understand correctly conversational speech when tested with or without hearing aids at a distance of 2 metres from and with the applicant’s back turned towards the examiner.

(2) If the hearing requirements can only be met with the use of hearing aid(s), the hearing aid(s) should provide optimal hearing function, be well-tolerated, and be suitable for aviation purposes.

(3) Applicants with hypoacusis should demonstrate satisfactory functional hearing ability.

(4) Applicants with profound deafness or major disorder of speech, or both, may be assessed as fit with an SSL such as ‘limited to areas and operations where the use of radio is not mandatory’. The aircraft should be equipped with appropriate alternative warning devices in lieu of sound warnings.

(b) Ear conditions

Applicants with:

(1) an active pathological process of the internal or middle ear;

(2) unhealed perforation or dysfunction of the tympanic membrane(s);

(3) disturbance of vestibular function;

(4) significant restriction of the nasal passages;

(5) sinus dysfunction;

(6) significant malformation or significant infection of the oral cavity or upper respiratory tract; or

(7) significant disorder of speech or voice

should undergo further examination to establish that the condition does not interfere with the safe exercise of the privileges of the licence.

AMC16 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

AMC17 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

ONCOLOGY

(a) In the case of malignant disease, applicants may be considered for a fit assessment if:

(1) there is no evidence of residual malignant disease likely to jeopardise flight safety;

(2) time appropriate to the type of tumour has elapsed since the end of primary treatment;

(3) the risk of in-flight incapacitation from a recurrence or metastasis is sufficiently low;

(4) there is no evidence of short or long-term sequelae from treatment that may jeopardise flight safety.

(b) Arrangements for an oncological follow-up should be made for an appropriate period of time.

(c) Applicants with an established history or clinical diagnosis of intracerebral malignant tumour should be assessed as unfit.

GM1 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

GM2 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

DIABETES MELLITUS TYPE 2 TREATED WITH INSULIN – CONVERSION TABLE FOR HbA1c IN % AND MMOL/MOL

HbA1c  in %

HbA1c  in mmol/mol

4,7

28

5,0

31

5,3

34

5,6

38

5,9

41

6,2

44

6,5

48

6,8

51

7,4

57

8,0

64

8,6

70

9,2

77

9,8

84

10,4

90

11,6

103

GM3 MED.B.095 Medical examination and assessment of applicants for LAPL medical certificates

ED Decision 2019/002/R

MOOD DISORDER

After full recovery from a mood disorder and after full consideration of the individual case, a fit assessment may be considered, depending on the characteristics and gravity of the mood disorder. If stability on maintenance psychoactive medication is confirmed, a fit assessment may be considered. If the dosage or type of medication is changed, a further evaluation may be required until stability is confirmed.