LegalizeReform history
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council Text with EEA relevance
27 versions
· 2011-11-03
2026-02-22
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2025-12-02
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2025-08-04
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2025-05-01
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2025-02-13
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
Changes on 2025-02-13
@@ -509,7 +509,7 @@
(c) Specific requirements for commercial air transport:
(a) Age 60-64. Aeroplanes and helicopters. The holder of a pilot licence who has attained the age of 60 years shall not act as a pilot of an aircraft engaged in commercial air transport except as a member of a multi-pilot crew.
(a) Age 60–64. Aeroplanes and helicopters. The holder of a pilot licence who has attained the age of 60 years shall not act as a pilot of an aircraft engaged in commercial air transport except as a member of a multi-pilot crew. By way of derogation, such holders shall be entitled to act as pilots of an aircraft engaged in single-pilot helicopter emergency medical service operations in accordance with Regulation (EU) No 965/2012, provided that they comply with the applicable requirements specified for that purpose in that Regulation and in Annex IV (Part-MED) to this Regulation.
(b) Age 65. Holders of a pilot licence who has attained the age of 65 years shall not act as a pilot of an aircraft that is engaged in commercial air transport.
@@ -4773,6 +4773,8 @@
— ‘colour safe’ means the ability of an applicant to readily distinguish the colours used in air navigation and to correctly identify aviation coloured lights;
— ‘helicopter emergency medical services (HEMS) operation’ means a ‘HEMS flight’ as defined in point 61 of Annex I to Regulation (EU) No 965/2012;
— ‘investigation’ means the assessment of a suspected pathological condition of an applicant by means of examinations and tests in order to verify the presence or absence of a medical condition;
— ‘accredited medical conclusion’ means the conclusion reached by one or more medical experts acceptable to the licensing authority, on the basis of objective and non-discriminatory criteria, for the purposes of the case concerned, in consultation with flight operations or other experts as necessary, for which an operational risk assessment may be appropriate;
@@ -4870,7 +4872,7 @@
(3) LAPL medical certificates shall be issued by an AeMC or an AME. They may also be issued by a GMP if so permitted under the national law of the Member State of the licensing authority to which the application for the medical certificate has been made.
(c) *Revalidation and renewal*
(1) Class 1 and class 2 medical certificates shall be revalidated and renewed by an AeMC or an AME.
(1) Class 1 and class 2 medical certificates shall be revalidated and renewed by an AeMC or an AME. Specifically, class 1 medical certificates for applicants who have reached the age of 60 and are involved in single-pilot HEMS operations shall be revalidated and renewed primarily by an AeMC or, at the discretion of the competent authority, by an experienced AME designated by the competent authority.
(2) LAPL medical certificates shall be revalidated and renewed by an AeMC or an AME. They may also be revalidated or renewed by a GMP if so permitted under the national law of the Member State of the licensing authority to which the application for the medical certificate has been made.
(d) The AeMC, AME or GMP shall only issue, revalidate or renew a medical certificate if both of the following conditions have been met:
@@ -4974,13 +4976,15 @@
(d) effect or side effect of any prescribed or non-prescribed therapeutic, diagnostic or preventive medication taken.
In their examination AMEs shall give proper consideration to the degenerative effects of ageing on the body systems.
(a) *Examination*
(1) A standard 12-lead resting electrocardiogram (ECG) and report shall be completed when clinically indicated and at the following moments:
(i) for a class 1 medical certificate, at the initial examination, then every 5 years until age 30, every 2 years until age 40, annually until age 50, and at all revalidation or renewal examinations thereafter;
(ii) for a class 2 medical certificate, at the initial examination, at the first examination after age 40 and then at the first examination after age 50, and every 2 years thereafter.
(2) An extended cardiovascular assessment shall be required when clinically indicated.
(3) For a class 1 medical certificate, an extended cardiovascular assessment shall be completed at the first revalidation or renewal examination after age 65 and every 4 years thereafter.
(4) For a class 1 medical certificate, estimation of serum lipids, including cholesterol, shall be required at the initial examination, and at the first examination after having reached the age of 40.
(3) For a class 1 medical certificate, an extended cardiovascular assessment shall be completed at the first revalidation or renewal examination after the age of 65 and every 4 years thereafter. For applicants involved in single-pilot HEMS operations, an extended cardiovascular assessment shall be completed at the first revalidation or renewal examination after the age of 60 and subject to a cardiovascular risk factor assessment thereafter.
(4) For a class 1 medical certificate, estimation of serum lipids, including cholesterol fractions, shall be required at the initial examination, and at the first examination after having reached the age of 40.
(b) *Cardiovascular System – General*
(1) Applicants for a class 1 medical certificate with any of the following medical conditions shall be assessed as unfit:
@@ -5002,6 +5006,7 @@
(xi) cardiovascular condition requiring systemic anticoagulant therapy.
(3) Applicants for a class 2 medical certificate with an established diagnosis of one of the conditions specified in points (1) and (2) shall be evaluated by a cardiologist before they may be assessed as fit, in consultation with the medical assessor of the licensing authority.
(4) Applicants with cardiac disorders other than those specified in points (1) and (2) may be assessed as fit subject to satisfactory cardiological evaluation.
(5) A cardiovascular risk factor assessment shall form part of examinations for class 1 and class 2 medical certificates at the first examination after reaching the age of 40 and at regular intervals thereafter.
(c) *Blood Pressure*
(1) Applicants' blood pressure shall be recorded at each examination.
@@ -5058,9 +5063,11 @@
(a) Applicants with significant impairment of pulmonary function shall be assessed as unfit. However, they may be assessed as fit once pulmonary function has recovered and is satisfactory.
(b) Applicants for a class 1 medical certificate shall undertake pulmonary morphological and functional tests at the initial examination and when clinically indicated.
(c) Applicants for a class 2 medical certificate shall undertake pulmonary morphological and functional tests when clinically indicated.
(b) Applicants for a class 1 medical certificate shall undertake pulmonary functional tests at the initial examination and when clinically indicated.
(ba) For class 1 medical certificate holders involved in single-pilot HEMS operations, pulmonary functional tests and obstructive sleep apnoea (OSA) screening shall be completed at the first revalidation or renewal examination after the age of 60.
(c) Applicants for a class 2 medical certificate shall undertake pulmonary morphological and functional tests when clinically or epidemiologically indicated.
(d) Applicants with a medical history or diagnosis of any of the following medical conditions shall undertake respiratory evaluation with a satisfactory result before they may be assessed as fit:
(1) asthma requiring medication;
@@ -5189,6 +5196,7 @@
(1) For a class 1 medical certificate:
(i) a comprehensive eye examination shall form part of the initial examination and shall be undertaken when clinically indicated and periodically, depending on the refraction and the functional performance of the eye.
(ii) a routine eye examination shall form part of all revalidation and renewal examinations.
(iii) when holders are involved in single-pilot HEMS operations, a comprehensive eye examination shall be completed at the first revalidation or renewal examination after the age of 60 and every year thereafter.
(2) For a class 2 medical certificate:
(i) a routine eye examination shall form part of the initial and all revalidation and renewal examinations.
(ii) a comprehensive eye examination shall be undertaken when clinically indicated.
@@ -5235,7 +5243,7 @@
(a) Applicants shall be assessed as unfit, where they cannot demonstrate their ability to readily perceive the colours that are necessary for the safe exercise of the privileges of the licence.
(b) *Examination and assessment*
(1) Applicants shall be subjected to the Ishihara test for the initial issue of a medical certificate. Applicants who pass that test may be assessed as fit.
(1) Applicants shall be subjected to the Ishihara test for the initial issue of a medical certificate. For class 1 medical certificate holders involved in single-pilot HEMS operations, a colour vision assessment shall be completed at the first revalidation or renewal examination after the age of 60 and every year thereafter. Applicants who pass that test may be assessed as fit.
(2) For a class 1 medical certificate:
(i) Applicants who do not pass the Ishihara test shall be referred to the medical assessor of the licensing authority and shall undergo further colour perception testing to establish whether they are colour safe.
(ii) Applicants shall be normal trichromats or shall be colour safe.
@@ -5246,9 +5254,10 @@
#### (a) *Examination*
(1) Applicants' hearing shall be tested at all examinations.
(i) For a class 1 medical certificate, and for a class 2 medical certificate when an instrument rating or *en route* instrument rating is to be added to the licence, hearing shall be tested with pure-tone audiometry at the initial examination, then every 5 years until the licence holder reaches the age of 40 and then every 2 years thereafter.
(i) For a class 1 medical certificate, and for a class 2 medical certificate when an instrument rating or a basic instrument rating is to be added to the licence, hearing shall be tested with pure-tone audiometry at the initial examination, then every 5 years until the licence holder reaches the age of 40, and then every 2 years until the licence holder reaches the age of 60 and every year thereafter.
(ii) When tested on a pure-tone audiometer, initial applicants shall not have a hearing loss of more than 35 dB at any of the frequencies 500, 1 000 or 2 000 Hz, or more than 50 dB at 3 000 Hz, in either ear separately. Applicants for revalidation or renewal with greater hearing loss shall demonstrate satisfactory functional hearing ability.
(2) A comprehensive ear, nose and throat examination shall be undertaken for the initial issue of a class 1 medical certificate and periodically thereafter when clinically indicated.
(3) For class 1 medical certificate holders involved in single-pilot HEMS operations, a comprehensive ear, nose and throat examination shall be completed at the first revalidation or renewal examination after the age of 60.
#### (b) Applicants with any of the following medical conditions shall undergo further examination to establish that the medical condition does not interfere with the safe exercise of the privileges of the applicable licence(s):
(1) hypoacusis;
@@ -5381,6 +5390,10 @@
(d) they have successfully completed practical training of a duration of at least 2 days, either at an AeMC or under the supervision of the competent authority.
(a) Training courses in aviation medicine refered to in MED.D.010(b) and MED.D.015 (c) shall only be provided after the prior approval of the course by the competent authority of the Member State where the training organisation has its principal place of business. In order to obtain such approval, the training organisation shall demonstrate that the course syllabus contains the learning objectives to acquire the necessary competencies and that the persons in charge of providing the training have adequate knowledge and experience.
(aa) For demonstrating compliance with points MED.D.010(b) and MED.D.015(c), an aviation medicine training course completed by an applicant outside the territories for which Member States are responsible under the Chicago Convention may be accepted by the competent authority, provided that the following conditions are met:
(i) the competent authority has assessed and verified the course syllabus in accordance with point ARA.MED.200(c)(1) of Annex VI;
(ii) the applicant has completed a specific training module on the aero-medical requirements detailed in this Annex (Part-MED) as provided by the competent authority.
(b) Except in the case of refresher training, the courses shall be concluded by a written examination on the subjects included in the course content.
@@ -6051,76 +6064,103 @@
***SPECIFIC REQUIREMENTS RELATING TO AERO-MEDICAL CERTIFICATION***
The competent authority shall appoint one or more medical assessor(s) to undertake the tasks described in this Section. The medical assessor shall be licensed and qualified in medicine and have:
(a) postgraduate work experience in medicine of at least 5 years;
(b) specific knowledge and experience in aviation medicine; and
(c) specific training in medical certification.
When an AeMC, or aero-medical examiner (AME) has referred the decision on the fitness of an applicant to the licensing authority:
(a) the medical assessor or medical staff designated by the competent authority shall evaluate the relevant medical documentation and request further medical documentation, examinations and tests where necessary; and
(b) the medical assessor shall determine the applicant’s fitness for the issue of a medical certificate with one or more limitation(s) as necessary.
The competent authority shall appoint one or more medical assessor(s) to undertake the aero-medical tasks described in this Regulation. The medical assessor shall be licensed and qualified in medicine and have the following:
(a) postgraduate work experience in clinical medicine;
(b) specific knowledge and experience in aviation medicine and aero-medical practice;
(c) specific training in aero-medical certification.
When an AeMC or aero-medical examiner (AME) has referred the decision on the fitness of an applicant to the medical assessor of the licensing authority, the following steps shall be taken:
(a) the medical assessor or medical staff designated by the medical assessor shall evaluate the relevant medical documentation and request further medical documentation, examinations and tests where necessary;
(b) the medical assessor shall determine the applicant’s fitness for the issuance of a medical certificate with one or more limitation(s) if necessary;
(c) the medical assessor shall inform the AeMC or AME of the decision;
(d) in case the applicant is assessed as fit, the medical assessor shall issue, if appropriate, the medical certificate or delegate the issuance to the AeMC or AME that referred the respective applicant.
(a) The licensing authority shall establish a procedure to limit, suspend or revoke a medical certificate.
(b) The licensing authority shall limit, suspend or revoke a medical certificate if there is evidence that:
(1) a medical certificate is falsified or obtained by a false declaration or false evidence;
(2) a medical certificate is used in violation of the provisions of point MED.A.020 of Annex IV;
(3) the holder of a medical certificate is no longer compliant with Annex IV (Part-MED);
(c) The licensing authority may also suspend or revoke a medical certificate upon the written request of the holder of a medical certificate.
(d) In case of limitation, suspension or revocation of a medical certificate, the licensing authority shall inform the issuing AME or AeMC about the reason for limitation, suspension or revocation.
(e) In case of suspension or revocation of a medical certificate, the licensing authority shall ensure that the provisions of point MED.A.046 of Annex IV (Part-MED) are complied with.
(f) The licensing authority shall establish a procedure for reinstating a medical certificate.
The competent authority shall establish a consultation procedure for the AeMCs and AMEs in accordance with Annex IV (Part-MED).
The medical certificate shall conform to the following specifications:
(a) Content
(1) State where the pilot licence has been issued or applied for (I),
(2) Class of medical certificate (II),
(3) Certificate number commencing with the UN country code of the State where the pilot licence has been issued or applied for and followed by a code of numbers and/or letters in Arabic numerals and latin script (III),
—————
(3) Medical certificate number commencing with the UN country code of the State where the pilot licence has been issued or applied for and followed by a code of numbers and/or letters in Arabic numerals and Latin script (III),
(4) Name of holder (IV),
(5) Nationality of holder (VI),
(6) Date of birth of holder: (dd/mm/yyyy) (XIV),
(6) Date of birth of holder: (dd/mm/yyyy) (IVa),
(7) Signature of holder (VII),
(8) Limitation(s) (XIII),
(9) Expiry date of the medical certificate (IX) for:
(i) Class 1 single pilot commercial operations carrying passengers,
(ii) Class 1 other commercial operations,
(i) Class 1,
(ii) Class 1 single-pilot commercial operations carrying passengers,
(iii) Class 2,
(iv) LAPL
(10) Date of medical examination
(11) Date of last electrocardiogram
(12) Date of last audiogram
(11) Date of last and next electrocardiogram
(12) Date of last and next audiogram
(12a) Date of last and next ophthalmological examination
(13) Date of issue and signature of the AME or medical assessor that issued the certificate. GMP may be added to this field if they have the competence to issue medical certificates under the national law of the Member State where the licence is issued.
(14) Seal or stamp (XI)
(b) Material: Except for the case of LAPL issued by a GMP the paper or other material used shall prevent or readily show any alterations or erasures. Any entries or deletions to the form shall be clearly authorised by the licensing authority.
(c) Language: Certificates shall be written in the national language(s) and in English and such other languages as the licensing authority deems appropriate.
(15) Other information
(b) The paper or other material used shall prevent or readily show any alterations or erasures. Any entries or deletions to the form shall be clearly authorised by the licensing authority.
(c) Language: Medical certificates shall be written in the national language(s) and in English and such other languages as the competent authority deems appropriate.
(d) All dates on the medical certificate shall be written in a dd/mm/yyyy format.
The competent authority shall use forms for:
The competent authority shall provide the AMEs with the format for the following documents:
(a) the application form for a medical certificate;
(b) the examination report form for class 1 and class 2 applicants; and
(b) the examination report form for class 1 and class 2 applicants;
(c) the examination report form for light aircraft pilot licence (LAPL) applicants.
The competent authority, when applicable, shall establish a notification process for general medical practitioners (GMPs) to ensure that the GMP is aware of the medical requirements laid down in MED.B.095.
(a) In addition to the records required in ARA.GEN.220, the competent authority shall include in its system of record-keeping details of aero-medical examinations and assessments submitted by AMEs, AeMCs or GMPs.
(b) All aero-medical records of licence holders shall be kept for a minimum period of 10 years after the expiry of their last medical certificate.
(c) For the purpose of aero-medical assessments and standardisation, aero-medical records shall be made available after written consent of the applicant/licence holder to:
The competent authority, when applicable, shall establish a notification process for general medical practitioners (GMPs) to ensure that the GMP is aware of the applicable requirements laid down in this Regulation.
(a) In addition to the records required in point ARA.GEN.220, the competent authority shall include in its system of record-keeping, details of aero-medical examinations, and assessments submitted by AMEs, AeMCs or GMPs.
(b) All aero-medical records of applicants/licence holders shall be kept for a minimum period of 10 years after the expiry date of their last medical certificate.
(c) For the purpose of aero-medical assessments and standardisation, aero-medical records shall be made available after written consent of the applicant/licence holder to the following entities:
(1) an AeMC, AME or GMP for the purpose of completion of an aero-medical assessment;
(2) a medical review board that may be established by the competent authority for secondary review of borderline cases;
(3) relevant medical specialists for the purpose of completion of an aero-medical assessment;
(4) the medical assessor of the competent authority of another Member State for the purpose of cooperative oversight;
(5) the applicant/licence holder concerned upon their written request; and
(6) after disidentification of the applicant/licence holder to the Agency for standardisation purposes.
(d) The competent authority may make aero-medical records available for other purposes than those mentioned in (c) in accordance with Directive 95/46/EC as implemented under national law.
(e) The competent authority shall maintain lists:
(1) of all AMEs that hold a valid certificate issued by that authority; and
(2) where applicable, of all GMPs acting as AMEs on their territory.
These lists shall be disclosed to other Member States and the Agency upon request.
(5) the applicant/licence holder concerned upon their written request;
(6) the Agency for standardisation purposes, in a manner that ensures that medical confidentiality is respected at all times.
(d) The competent authority may make aero-medical records available for other purposes than those mentioned in point (c) in accordance with Regulation (EU) 2016/679.
(e) The competent authority shall maintain a list of:
(1) AeMCs and AMEs that it has certified;
(2) AMEs certified by other competent authorities exercising their privileges in its territory and to whom it has provided a briefing in accordance with point MED.D.001(f)(3) of Annex IV (Part-MED);
(3) GMPs exercising their privileges in accordance with point MED.A.040 of Annex IV (Part-MED), where applicable;
(4) OHMPs having notified the competent authority of their intention to perform cabin crew aero-medical assessments in accordance with points MED.C.005(c) and MED.D.040 of Annex IV (Part-MED), where applicable.
The list shall state the privileges of the persons and organisations specified in points (1) to (4) of the first paragraph and shall be published and kept updated by the competent authority.
(f) The competent authority shall analyse the health data of pilots above the age of 60, especially of those involved in single-pilot HEMS operations, and report such health data in an anonymised and aggregated manner to EASA on a yearly basis.
(a) The Agency shall establish and manage a central repository, the European Aero-Medical Repository (EAMR).
@@ -6144,61 +6184,63 @@
(h) The Agency shall ensure that applicants for or holders of class 1 medical certificates can access any information relating to them contained in EAMR and that they are informed that they can request that information to be rectified or deleted. The licensing authorities shall assess such requests and, where they consider that the information concerned is incorrect or not necessary for the purposes specified in point (b), ensure that the information is rectified or deleted.
(a) The certification procedure for an AME shall follow the provisions laid down in ARA.GEN.315. Before issuing the certificate, the competent authority shall have evidence that the AME practice is fully equipped to perform aero-medical examinations within the scope of the AME certificate applied for.
(b) When satisfied that the AME is in compliance with the applicable requirements, the competent authority shall issue, revalidate, renew or change the AME certificate for a period not exceeding 3 years, using the form established in appendix VII to this Part.
Without prejudice to the provisions laid down in point ARA.GEN.315, all of the following shall apply:
(a) the competent authority shall ensure that before the issue, revalidation, renewal or extension of privileges of an AME certificate, applicants demonstrate their aero-medical competency in accordance with points MED.D.030(a)(6) and (b)(5) of Annex IV;
(b) the competent authority shall have a procedure in place to ensure that, before issuing the AME certificate, it has the evidence that the AME practice is equipped and the appropriate processes are in place to perform aero-medical examinations within the scope of the AME certificate applied for. In the case of multiple AME practice locations, all of them shall be specified on the AME certificate;
(c) for applicants referred to in point MED.D.020(aa) of Annex IV, the competent authority may accept an aviation medicine training course completed by an applicant outside the territories for which Member States are responsible under the Chicago Convention, provided that the competent authority has done all of the following:
(1) assessed and verified that the course syllabus is equivalent to the aviation medicine training courses available in the Member States;
(2) provided to the applicant a specific training module on the aero-medical requirements detailed in Annex IV (Part-MED);
(d) when satisfied that the AME is in compliance with the applicable requirements, the competent authority shall issue, revalidate, renew or change the AME certificate for a period not exceeding 3 years, using the form established in Appendix VII.
The competent authority of a Member State shall notify the Agency and competent authorities of other Member States if aero-medical examinations for the LAPL can be carried out on its territory by GMPs.
When developing the continuing oversight programme referred to in ARA.GEN.305, the competent authority shall take into account the number of AMEs and GMPs exercising their privileges within the territory where the competent authority exercises oversight.
(a) The competent authority shall limit, suspend or revoke an AME certificate in cases where:
(1) the AME no longer complies with applicable requirements;
When developing the continuing oversight programme referred to in point ARA.GEN.305, the competent authority shall take into account:
(1) the number of AMEs and GMPs exercising their privileges within the territory where the competent authority exercises oversight;
(2) the number of AMEs certified by competent authorities of other Member States exercising their privileges within the territory where the competent authority exercises oversight;
(3) a risk-based assessment of the AMEs’ and GMPs’ activity.
Without prejudice to the provisions laid down in point ARA.GEN.300(e):
(a) where an AME or AeMC carries out their activity in more than one Member State, the competent authority that certified the AME or AeMC shall have a procedure in place to ensure the exchange of information in accordance with point ARA.GEN.200(c) and points ARA.GEN.300(d) and (e) with the competent authority of the other Member State(s) where the AME or AeMC carries out their activity. The procedure shall be agreed upon by the competent authorities involved;
(b) in the case mentioned in point (a), the competent authority of the other Member State(s) where the AME or AeMC carries out their activity shall share all information relevant to the oversight of the AME or AeMC with the competent authority certificating the AME or AeMC.
#### (a) The competent authority shall limit, suspend or revoke an AME certificate in the following circumstances:
(1) the AME does not comply with applicable requirements;
(2) failure to meet the criteria for certification or continuing certification;
(3) deficiency of aero-medical record-keeping or submission of incorrect data or information;
(4) falsification of medical records, certificates or documentation;
(5) concealment of facts appertaining to an application for, or holder of, a medical certificate or false or fraudulent statements or representations to the competent authority;
(6) failure to correct findings from audit of the AME practice; and
(7) at the request of the certified AME.
(b) The certificate of an AME shall be automatically revoked in either of the following circumstances:
(6) failure to correct findings from audit of the AME practice; —————
(7) at the request of the certified AME; and
(8) any operational context of the AME that may have a direct or indirect negative impact on flight safety.
#### (b) The certificate of an AME shall be considered invalid in either of the following circumstances and the competent authority shall immediately revoke it:
(1) revocation of medical licence to practice; or
(2) removal from the Medical Register.
If, during oversight or by any other means, evidence is found showing a non-compliance of an AeMC, an AME or a GMP, the licensing authority shall have a process to review the medical certificates issued by that AeMC, AME or GMP and may render them invalid where required to ensure flight safety.
The licensing authority shall have a process in place to:
#### (a) review examination and assessment reports received from the AeMCs, AMEs and GMPs and inform them of any inconsistencies, mistakes or errors made in the assessment process; and
#### (b) assist AMEs and AeMCs on their request regarding their decision on aero-medical fitness in contentious cases.
The competent authority shall establish a procedure for the review of borderline and contentious cases with independent medical advisors, experienced in the practice of aviation medicine, to consider and advise on an applicant’s fitness for medical certification.
(a) When new medical technology, medication or procedures are identified that may justify a fit assessment of applicants otherwise not in compliance with the requirements, research may be carried out to gather evidence on the safe exercise of the privileges of the licence.
(b) In order to undertake research, a competent authority, in cooperation with at least one other competent authority, may develop and evaluate a medical assessment protocol based on which these competent authorities may issue a defined number of pilot medical certificates with appropriate limitations.
(c) AeMCs and AMEs may only issue medical certificates on the basis of a research protocol if instructed to do so by the competent authority.
(d) The protocol shall be agreed between the competent authorities concerned and shall include as a minimum:
(1) a risk assessment;
(2) a literature review and evaluation to provide evidence that issuing a medical certificate based on the research protocol would not jeopardise the safe exercise of the privileges of the licence;
(3) detailed selection criteria for pilots to be admitted to the protocol;
(4) the limitations that will be endorsed on the medical certificate;
(5) the monitoring procedures to be implemented by the competent authorities concerned;
(6) the determination of end points for terminating the protocol.
(e) The protocol shall be compliant with relevant ethical principles.
## (f) The exercise of licence privileges by licence holders with a medical certificate issued on the basis of the protocol shall be restricted to flights in aircraft registered in the Member States involved in the research protocol. This restriction shall be indicated on the medical certificate.
### (g) The participating competent authorities shall:
(1) provide the Agency with:
(i) the research protocol before implementation;
(ii) the details and qualifications of the nominated focal point of each participating competent authority;
(iii) documented reports of regular evaluations of its effectiveness;
(2) provide the AeMCs and AMEs within their jurisdiction with details of the protocol before implementation for their information.
(c) The competent authority shall have a process in place for retrieval of the revoked AME certificates, shall update the AME list, and inform the competent authorities of the other Member States accordingly.
If, during oversight or by any other means, evidence is found showing a non-compliance of an AeMC, an AME or a GMP, the competent authority shall have a process to review the medical certificates issued by that AeMC, AME or GMP and may render them invalid, where required, to ensure flight safety.
For medical certificates issued to applicants who have a licensing authority different from the competent authority that issued the AME certificate, that competent authority shall inform and exchange relevant information with the medical assessor of the licensing authority of the affected medical certificate holder.
The licensing authority shall have a process in place for the medical assessor to take the following steps:
(a) review examination and assessment reports received from the AeMCs, AMEs and GMPs and inform them of any inconsistencies, mistakes or errors made in the assessment process;
(aa) take the appropriate corrective actions for any inconsistencies, mistakes or errors identified;
## (b) assist AMEs and AeMCs on their request regarding their decision on aero-medical fitness in borderline and complex cases.
### The competent authority shall establish a procedure for the review of borderline and complex cases and cases where an applicant requests a review in accordance with the applicable medical requirements and accredited medical conclusion as defined in point MED.A.010 of Annex IV (Part-MED).
SUBPART DTO
@@ -6356,15 +6398,15 @@
## (b) all operations are conducted in compliance with Part-ORA, Part-FCL, Part-BFCL, Part-SFCL [ADJUST AS APPLICABLE], other applicable regulations, and, when relevant, with the procedures in the organisation’s documentation as required by Part-ORA.
## Date of issue:
Signed: [Competent Authority]
## For the Member State/EASA
## EASA Form 143 Issue 3 – page 2/2
### Appendix IV to ANNEX VI PART-ARA
### Date of issue:
### Signed: [Competent Authority]
### For the Member State/EASA
#### EASA Form 143 Issue 3 – page 2/2
Appendix IV to ANNEX VI PART-ARA
**FLIGHT SIMULATION TRAINING DEVICE QUALIFICATION CERTIFICATE**
@@ -6376,11 +6418,88 @@
Appendix V to ANNEX VI PART-ARA
## Appendix VI to ANNEX VI PART-ARA
### (BLANK PAGE)
#### Appendix VII to ANNEX VI PART-ARA
#### **CERTIFICATE FOR AERO-MEDICAL CENTRES (AeMCs)**
**European Union**
(<sup>9</sup>)
**Competent Authority**
**AERO-MEDICAL CENTRE CERTIFICATE**
Pursuant to Commission Regulation (EU) No 1178/2011 and Regulation (EU) 2015/340 (<sup>10</sup>) and subject to the conditions specified below, the [competent authority] hereby certifies
## as a Part-ORA certified Aero-medical centre with the privileges and the scope of activities as listed in the attached terms of approval.
1. This certificate is limited to that specified in the scope of approval section of the approved organisation manual;
## 2. This certificate requires compliance with the procedures specified in the organisation documentation as required by Part- ORA.
### 3. This certificate shall remain valid subject to compliance with the requirements of Part-ORA unless it has been surrendered, superseded, suspended or revoked.
Date of issue: dd/mm/yyyy
Signature: [Competent Authority]
### EASA Form 146 Issue 2
### **AERO-MEDICAL CENTRE CERTIFICATE**
#### Attachment (<sup>11</sup>) to AeMC certificate number:
[Name of the organisation] has obtained the privilege(s) to undertake aero-medical examinations and assessments for the issuance of medical certificates and medical reports as stated in the table below and to issue these medical certificates and medical reports for:
| | Initial/revalidation/renewal | Date of issue |
| --- | --- | --- |
| Class 1 | | |
| Class 2/LAPL/Cabin Crew | | |
| Class 3 (<sup>1</sup>) | | |
| (<sup>1</sup>) Class 3 shall be added only for the AeMCs approved to perform class 3 aero-medical examinations. | | |
| Date: dd/mm/yyyy | Signature: [Competent Authority] |
| --- | --- |
Appendix VI to ANNEX VI PART-ARA
(BLANK PAGE)
Appendix VII to ANNEX VI PART-ARA
#### **CERTIFICATE FOR AERO-MEDICAL EXAMINERS (AMEs)**
**European Union**
(<sup>12</sup>)
**Competent Authority**
**AERO-MEDICAL EXAMINER CERTIFICATE**
Pursuant to Commission Regulation (EU) No 1178/2011 and Regulation (EU) 2015/340 (<sup>13</sup>) and subject to the conditions specified below, the [competent authority] hereby certifies
## as aero-medical examiner
### 1. This certificate is limited to the privileges specified in the attachment to this AME certificate;
2. This certificate requires compliance with the implementing rules and procedures specified in Part-MED/Part ATCO.MED (13) .
3. This certificate shall remain valid from [dd/mm/yyyy] until [dd/mm/yyyy (<sup>14</sup>)] subject to compliance with the requirements of Part-MED/Part ATCO.MED (13) unless it has been surrendered, superseded, suspended or revoked.
Date of issue: dd/mm/yyyy
Signature: [Competent Authority]
EASA Form 148 Issue 2
**AERO-MEDICAL EXAMINER CERTIFICATE**
Attachment (<sup>15</sup>) to the AME certificate number:
## [Name and academic title of the aero-medical examiner] has obtained the privilege(s) to undertake aero-medical examinations and assessments for the issuance of medical certificates and medical reports as stated in the table below and to issue these medical certificates and medical reports for:
### | Class 1 revalidation/renewal | [valid until]/[Not Applicable] |
| --- | --- |
| Class 2/LAPL/Cabin crew Initial/revalidation/renewal | [valid until] |
| Class 3 (<sup>1</sup>) revalidation/renewal | [valid until]/[Not Applicable] |
| (<sup>1</sup>) Class 3 shall be added only for the AMEs approved to perform class 3 aero-medical examinations. | |
#### | Date of issue: dd/mm/yyyy | Signature: [Competent Authority] |
| --- | --- |
#### Appendix VIII to ANNEX VI (Part-ARA)
@@ -6825,33 +6944,50 @@
***AERO-MEDICAL CENTRES***
This Subpart establishes the additional requirements to be met by an organisation to qualify for the issue or continuation of an approval as an aero-medical centre (AeMC) to issue medical certificates, including initial class 1 medical certificates.
This Subpart establishes the additional requirements to be met by an organisation to qualify for the issue or continuation of an approval as an aero-medical centre (AeMC) to:
(a) provide aero-medical expertise and practical training for AMEs;
(b) issue medical certificates and cabin crew medical reports, including initial class 1 medical certificates, or class 3 medical certificates in accordance with Commission Regulation (EU) 2015/340 (<sup>16</sup>), or both, as applicable.
Applicants for an AeMC certificate shall:
(a) comply with MED.D.005; and
(b) in addition to the documentation for the approval of an organisation required in ORA.GEN.115, provide details of clinical attachments to or liaison with designated hospitals or medical institutes for the purpose of specialist medical examinations.
The AeMC certificate shall be issued for an unlimited duration. It shall remain valid subject to the holder and the aero-medical examiners of the organisation:
(a) complying with MED.D.030;and
(b) ensuring their continued experience by performing an adequate number of class 1 medical examinations every year.
(b) in addition to the documentation for the approval of an organisation required in point ORA.GEN.115, provide details of activities that are contracted to designated hospitals or medical institutes for the purpose of specialist medical examinations.
An organisation holding an AeMC certificate shall not, at any time, hold more than one AeMC certificate issued with the same scope in accordance with Regulation (EU) 2018/1139 and the implementing and delegated acts adopted on the basis thereof.
The AeMC certificate shall be issued for an unlimited duration. It shall remain valid subject to the holder and the aero-medical examiners of the organisation complying with the following conditions:
(a) complying with point MED.D.030 of Annex IV (Part-MED) to this Regulation or point ATCO.MED.C.025 of Annex IV (Part-ATCO.MED) to Regulation (EU) 2015/340, as applicable;
(b) ensuring their continued experience by performing an adequate number of class 1 medical examinations, or class 3 medical examinations in accordance with Regulation (EU) 2015/340, or equivalent military aero-medical examinations, as appropriate, every year.
The AeMC shall provide the competent authority with statistical reports regarding the aero-medical assessments of applicants, including reports of the drugs and alcohol screening performed in accordance with point MED.B.055(b) of Annex IV (Part-MED) and any health risk factors or trends identified during the aero-medical assessments.
The AeMC shall establish and maintain a management system that includes the items addressed in ORA.GEN.200 and, in addition, processes:
## (a) for medical certification in compliance with Part-MED; and
### (b) to ensure medical confidentiality at all times.
#### (a)The AeMC shall:
(1) have an aero-medical examiner (AME) nominated as head of the AeMC, with privileges to issue class 1 medical certificates and sufficient experience in aviation medicine to exercise his/her duties; and
(2) have on staff an adequate number of fully qualified AMEs and other technical staff and experts.
(b)The head of the AeMC shall be responsible for coordinating the assessment of examination results and signing reports, certificates, and initial class 1 medical certificates.
(a) for medical certification in compliance with Part-MED;
(aa) to facilitate cooperation between the AMEs and other medical experts of the AeMC; and
## (b) to ensure medical confidentiality at all times.
### Notwithstanding point ORA.GEN.205, all of the following shall apply:
#### (a) minimum required aero-medical examinations shall be performed within the organisation of the AeMC, in accordance with the scope and privileges defined in the terms of approval attached to the AeMC’s certificate;
(b) additional medical examinations and investigations may be performed by contracted individual experts or organisations. The organisation shall ensure that when contracting any part of its activity, the contracted service or product conforms to the applicable requirements.
(a) The AeMC shall have the following in its staff:
(1) an aero-medical examiner (AME) nominated as head of the AeMC, with privileges to issue class 1 medical certificates, or class 3 medical certificates in accordance with Regulation (EU) 2015/340, as applicable, in accordance with the scope defined in the terms of approval attached to the AeMC’s certificate and sufficient experience in aviation medicine to exercise his or her duties;
(2) at least one additional qualified AME with privileges to issue class 1 medical certificates, or class 3 medical certificates in accordance with Regulation (EU) 2015/340, as applicable, in accordance with the scope defined in the terms of approval attached to the AeMC’s certificate privileges, and other technical staff;
(3) available medical experts.
(b) The head of the AeMC shall be responsible for:
(1) coordinating the assessment of examination results;
(2) signing reports, certificates, and initial class 1 medical certificates and class 3 medical certificates in accordance with Regulation (EU) 2015/340.
The AeMC shall be equipped with medico-technical facilities adequate to perform aero-medical examinations necessary for the exercise of the privileges included in the scope of the approval.
2024-12-02
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2024-08-14
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2022-10-30
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2022-06-20
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2022-01-31
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2021-09-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2021-01-12
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2020-06-22
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2020-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2019-12-21
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2019-11-11
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2019-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2019-01-30
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2019-01-09
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2018-09-02
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2018-08-25
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2018-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2016-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2015-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2014-04-03
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2014-02-17
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down
2012-04-08
Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying do
original version
Text at this date