1. Module 07 – MEDICAL CERTIFICATION Commission Regulation No. 2015/340

2. Training Objectives  Appreciate the provisions of Commission Regulation (EU) 2015/340 of 20 February 2015 laying down technical requirements and administrative procedures relating to air traffic controllers' licences and certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council, amending Commission Implementing Regulation (EU) No 923/2012 and repealing Commission Regulation (EU) No 805/2011  Appreciate comparison with 805/2011 ©2015 EUROCONTROL 2

3. 3 The requirements  Some articles in the core of the regulation  Annex IV, PART ATCO.MED (in full includes the medical criteria for assessment)  Annex III, PART ATCO.OR, Subpart E - Requirements for Aero-medical centres  Annex II, PART ATCO.AR, Subpart F – Specific requirements for aero-medical certification ©2015 EUROCONTROL 3

4. 4 Core of the regulation  Art 2 - Compliance with requirements  Medical certification of SATCOs and ATCOs shall be compliant with technical requirements and administrative procedures in ANNEX III and IV  Art 6 – Competent authority  For Annex III (PART ATCO.OR - Requirements for ATC training organisations and aero-medical centres) and oversight of Annex I  the authority nominated or established by the Member State as its CA for oversight  the Agency, principal place of operation or registered office is outside the MS  For Annex IV (PART ATCO.MED - Medical requirements for ATCOs)  For AMC – the authority designated/ the Agency when the AMC is located in a 3 rd country  For AMEs - the authority designated/ if located in a 3 rd country, the authority designated by MS to which the AME applies for certificate ©2014 EUROCONTROL 4

5. 5 Annex IV – Part ATCO.MED  Subpart A - General requirements  Section 1 – General  Section 2 – Requirements for medical certificates  Subpart B – Requirements for ATCO medical certificates  Section 1 – General  Section 2 – Medical requirements for Class 3 Medical certificates !!  (THIS SECTION WILL NOT BE TREATED IN THIS COURSE)  Subpart C – Aero-medical examiners (AME) ©2015 EUROCONTROL 5

6. 6 Annex IV, Subpart A, Section 1 ©2015 EUROCONTROL 6

7. 7 ATCO.MED.A.001 – Competent authority for AMEs and AeMCs – already mentioned (clarification from 805/2011) ATCO.MED.A.005 – Scope (no difference from 805/2011)  Issue, validity, revalidation and renewal of medical certificates for SATCO and ATCO and not STDIs  Certification of AMEs (more details about this than in 805/2011) ATCO.MED.A.010 – Definitions (more details)  The added definition will help the AMEs, the responsible persons in the AMCs dealing with Class 3 to better understand the requirements  Limitation (a condition to comply with), Significant (degree of med. cond. Which would prevent the safe exercise of licence) ATCO.MED.A.015 – Medical confidentiality (added which was not before in 805/2011) ©2015 EUROCONTROL 7

8. 8 ATCO.MED.A.020 – Decrease in medical fitness (clarification from 805/2011)  Holder of licence shall not exercise privileges  Are aware of any decrease in medical fitness (same as Art 17 a) of 805/2011)  Take or use any prescribed or non-prescribed medication  Receive any medical, surgical or other treatment  Holder of class 3 medical certificate shall seek aero-medical advice before exercising the licence, when: (more explanations)  Undergone a surgical operation or invasive procedure;  Have commenced the regular use of any medication  Have suffered any significant injury involving incapacity to exercise the licence;  Have been suffering from any significant illness involving incapacity to exercise the licence;  Are pregnant;  Have been admitted to hospital or medical clinic  First require correcting lenses  AeMC or AME shall assess the medical fitness to decide FIT/UNFIT to resume work ©2015 EUROCONTROL 8

9. 9  When conducting aero-medical examination and assessments, the AeMC or AME shall:  Ensure communication with applicant without language barriers;  Make aware the applicant of the consequences of providing incomplete or false statements of the medical history;  Notify the Licensing Authority if the applicant provides inaccurate, false or incomplete statement of medical history;  Notify Licensing Authority when the applicant withdraw the application at any stage of the process ©2015 EUROCONTROL 9 ATCO.MED.A.025 – Obligations of AeMC and AME (clarification from 805/2011) /1

10. 10  After completion of aero-medical examination and assessments:  Advise the applicant whether FIT, UNFIT or referred to the licensing authority  Inform the applicant of any limitations  If UNFIT, inform the applicant about the right of a review of the decision;  Submit to the licensing authority: a signed report containing detailed results of the exam and assessment and a copy of application form, exam form & med. certif.  Inform applicant of the responsibility in case of decrease medical fitness ©2015 EUROCONTROL 10 ATCO.MED.A.025 – Obligations of AeMC and AME (clarification from 805/2011) /2

11. 11 Annex IV, Subpart A, Section 2 ©2015 EUROCONTROL 11

12. 12  Applicant or holders of ATCO or SATCO licence shall hold class 3 medical certificate.  A licence holder shall have only one medical certificate in accordance with this Part. ©2015 EUROCONTROL 12 ATCO.MED.A.030 – Medical certificates (clarification from 805/2011)

13. 13  Application shall be made in a format established by CA (format provided in the AMC for Annex II)  Applicant shall provide AMC or AME:  Proof of identity  A signed declaration:  medical facts concerning medical history;  have previously applied for medical certificate or have undergone an examination and with what result;  if they have been assessed UNFIT or had a medical certificate suspended or revoked  When revalidating or renewal of medical certificate, applicant shall present the most recent medical certificate  Most details had been part of the procedure required by 805/2011 ©2015 EUROCONTROL 13 ATCO.MED.A.035 – Application for medical certificate (art 15 -805/2011)

14. 14  Issuance, revalidation or renewal of medical certificate – examinations and assessment completed – applicant is declared FIT.  Initial issue – by AeMC  Revalidation or renewal – by AeMC or AME  AeMC or AME shall only issue, revalidate or renew a medical certif. if:  Provided a complete medical history and if required by AeMC/AME results of aero- medical exam and tests conducted by the applicant’s physician of specialists.  AeMC or AME has conducted assessments based on exam and tests required to verify compliance with the requirements  AeMC, AME may require the applicant to undergo additional exam and investigations when clinically indicated, before the certificate is issued, revalidated or renewed.  805/2011, Art 15 with better clarification ©2015 EUROCONTROL 14 ATCO.MED.A.040 – Issue, revalidation and renewal of medical certificates

15. 15  Validity.  24 months below 40 years  12 months when applicant reached 40 years (issued before 40 years shall cease validity when 41 years)  Validity period including any associated exam or special investigations shall be:  Determined by the age and when the date of exam takes place  Calculated from the date of the exam in case of issue and renewal and  Calculated from the expiry date of the previous certificate in case of revalidation.  Revalidation – exam and assessments undertake up to 45 days prior to expiry  805/2011, Art 16 better clarification ©2015 EUROCONTROL 15 ATCO.MED.A.045 – Validity, revalidation and renewal of medical certificates/1

16. 16  Renewal.  If a holder does not undergo a revalidation – renewal  Situations  Medical certificate has expired for:  Less than 2 years – routine revalidation examination  More than 2 years – AMC or AME shall conduct renewal exam after the assessment of aero-medical records  More than 5 years – exam for initial issue shall apply and assessment is based on the revalidation requirements  805/2011, Art 16 better clarification ©2015 EUROCONTROL 16 ATCO.MED.A.045 – Validity, revalidation and renewal of medical certificates /2

17. 17 ©2015 EUROCONTROL 17 ATCO.MED.A.046 – Suspension or revocation of medical certificate   Revocation - holder shall return to LA medical certificate   Suspension - holder shall return to LA medical certificate, on request of LA   Better explanations from 805/2011

18. 18 Annex IV, Subpart B, Section 1 ©2015 EUROCONTROL 18

19. 19 Limitations to class 3 medical certificates  In case the applicant does not fully comply with medical requirements, but he is consider not to jeopardies the safe exercise of the licence, AeMC or AME shall:  Refer the decision on fitness to LA;  Evaluate if the applicant is able to perform the duties when complying with one or more limitations endorsed on the certificate – issue the certificate with limitations  AeMC or AME may revalidate or renew the certificate with the same limitation(s) without referring to the LA ©2015 EUROCONTROL 19 ATCO.MED.B.001 – Limitation to medical certificates /1

20. 20  When assessing if a limitation is necessary, particular consideration:  If the accredited medical conclusion indicates that the failure does not jeopardise the safe exercise of the licence  Applicant’s experience to the operation performed  Operational limitations  CA and ANSP shall determine the operational limitations applicable in a specific operational environment  Appropriate operation limitations in medical certificate – only by the LA  Any other limitation may be imposed to ensure the safe exercise of the licence  Shall be specified in the certificate  805/2011 Art 16 better clarification ©2015 EUROCONTROL 20 ATCO.MED.B.001 – Limitation to medical certificates /2

21. 21 Annex IV, Subpart C, AMEs ©2015 EUROCONTROL 21

22. 22  AME – revalidate and renew medical certificate and conduct relevant examinations and assessments.  Scope of privileges – to be inserted in the AME certificate  Holders of AME certificates shall not undertake examinations in other MS than the MS that issued the certificate unless:  Have been granted access by the host MS to exercise professional activities as a specialised doctor;  Have informed CA of the host MS of the intention to conduct exam and assessments and issue medical certificates within the scope of AME privileges  Have received a briefing from CA of the host MS. ©2015 EUROCONTROL 22 ATCO.MED.C.001 – Privileges (art 15, 16; clarification from 805/2011

23. 23  Application for AME certificate – procedure established by the CA (!!)  CA is provided with:  Personal details and professional address  Documentation demonstrating they comply the requirements including certificate of completion of training courses in av. medicine  Written declaration of the AME that he will issue med certif in accordance with this Part  AME does exam in more than one location - provide CA with information all practice locations and practice facilities ©2015 EUROCONTROL 23 ATCO.MED.C.005 – Application (art 15, 16; clarification from 805/2011)

24. 24  Applicants for an AME certificate shall:  Be fully qualified and licensed for the practice of medicine and hold a Certificate of Completion, or have evidence of, specialist medical training;  Have successfully completed basic and advanced training courses in aviation medicine, including specific modules for the aero-medical assessment of ATCOs and the specific environment in air traffic control  Demonstrate to the competent authority that they have adequate facilities, procedures, documentation and functioning equipment suitable for aero- medical examinations; and have in place the necessary procedures and conditions to ensure medical confidentiality. ©2015 EUROCONTROL 24 ATCO.MED.C.010–Requirements for the issue an AME certificate (clarification from 805/2011)

25. 25  Training courses in aviation medicine shall be approved by the competent authority of the Member State where the training provider has its principal place of business.  The training provider 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.  Except in the case of refresher training, the courses shall be concluded by a written examination on the subjects included in the course.  The training provider shall issue a certificate of completion when exam is passed  Basic training 60 hours and have subjects as per AMC  Advanced training 60 hours and have subjects as per AMC ©2015 EUROCONTROL 25 ATCO.MED.C.015 – Training courses in aviation medicine

26. 26  AMEs shall notify the CA of the following circumstances which could affect their certificate:  the AME is subject to disciplinary proceedings or investigation by a medical regulatory body;  there are any changes to the conditions on which the certificate was granted, including the content of the statements provided with the application  the requirements for the issue of an AME certificate are no longer met  there is a change to the aero-medical examiner’s practice location(s) or correspondence address.  Failure to inform the CA - suspension or revocation of the privileges of the AME certificate by CA ©2015 EUROCONTROL 26 ATCO.MED.C.020 – Changes to the AME certificate

27. 27  For a period not exceeding 3 years  Revalidation provided:  continues to fulfil the general conditions required for medical practice and maintains registration as a medical practitioner  has undertaken refresher training in aviation medicine and in the working environments of air traffic controllers within the last 3 years  AMC: Refresher training 20 hours including ATC environment  AMC: Attendance at scientific meetings and congress can be considered for a specified number of hours in the refresher training  has performed at least 10 aero-medical examinations every year (may be reduced by CA)  remains in compliance with the terms of their AME certificate and exercises the AME privileges in accordance with this Part. ©2015 EUROCONTROL 27 ATCO.MED.C.025 – Validity of AME certificate

28. 28 Annex III, PART ATCO.OR, Subpart E, Requirements for AeMC ©2015 EUROCONTROL 28

29. 29 ATCO.OR.E.001 – Aero-medical centres  Aero-medical centres (AeMCs) shall apply the provisions of Subparts ORA.GEN and ORA.AeMC of Annex VII to Commission Regulation (EU) No 290/2012, with:  (a)all references to class 1 to be replaced with class 3; and  (b)all references to Part MED to be replaced with Part ATCO.MED. !!! Makes reference to the pilots regulations!!!! HOW CAN THIS BE PROCEEDED? ©2015 EUROCONTROL 29

30. 30 Annex II, PART ATCO.AR, Subpart F, Specific requirements for aero-medical certification ©2015 EUROCONTROL 30

31. 31 Specific requirements relating to AeMC certification  Requirements for CA not AeMC or AME! Section 1  Commission regulation (EU) No 1178/2011 (Aircrew Regulation)  Annex VI : list of the requirements to be applied Section 2  Description of the ATCO medical certificate: content/fields, material, language, dates format  AME certificate – form is in Appendix 3 of Annex II  AeMC certificate – form is Appendix 4 of Annex II  CA shal provide AMEs and AeMCs with forms:  Application form for a medical certificate  Examination report form for class 3 applicants (already provided in AMC to Annex II) ©2015 EUROCONTROL 31

32. Medical Certification according to the 805/2011 ©2015 EUROCONTROL 32

33. 33 Medical certification  Application and issue of a medical certificate (Art. 15)  Validity of a medical certificate (Art. 16)  Reduced medical fitness (Art. 17) ©2015 EUROCONTROL 33

34. 34 Art. 15 - Application and issue of medical certificates  Application for the issue, revalidation or renewal of medical certificates shall be submitted to CA  Established Procedure  Medical certificates shall be issued by  Competent medical body of the CA or  Aero Medical Examiners (AME) or by Aero Medical Centres (AMC)  Approved by CA  Medical requirements  ICAO Annex 1 and  EUROCONTROL Requirements for European Class 3 Medical Certification of ATCO  CA to ensure that Review and appeal procedures are in place  Independent medical advisors ©2015 EUROCONTROL 34

35. 35 Art.16 - Validity of Medical Certificates  Validity  24 months until the age of 40 years  12 months after the age of 40 years  Explanations  How to count the months for the two options  Examination might be taken 45 days before the expiry date  No examination by the expiry date of the certificate, a renewal examination is required  Medical certificate may be limited, suspended or revoked ©2015 EUROCONTROL 35

36. 36 Art. 17 - Reduced Medical Fitness  Requirements placed on individuals  Not exercise the privileges of the licence when aware of any decrease in medical fitness  Notify the ANSP (the management)  Become aware of any decrease in medical fitness  Are under the influence of psychoactive substances  Are under the influence of medicines  ANSP shall establish procedures  To manage the operational impact of cases of reduced medical fitness  Inform CA when a licence holder was assessed as medically UNFIT  Procedures have to be approved by the CA  What is the content of such procedures? ©2015 EUROCONTROL 36

37. 37 Conclusions  Parts of 805/2011 had been kept and detailed  What was previously procedure is offered today as requirements  Procedures have not disappeared  AeMC and AME requirements better defined and aligned with the ones from OPS  AMC and GUI materials may clarify some parts ©2015 EUROCONTROL 37

38. 38 Questions? ©2015 EUROCONTROL 38