Opinion 09/2016

Update of Part-MED (Annex IV to Commission Regulation (EU) No 1178/2011)

This Opinion addresses efficiency/proportionality as well safety issues related to Annex IV (Part-MED) to Commission Regulation (EU) No 1178/2011. As both rulemaking tasks (RMTs), RMT.0287 and RMT.0700, amend the provisions prescribed in Part-MED, EASA decided to merge the outcome of the respective consultations and publish one Opinion on the update of Part-MED to prevent any inconsistencies that may emerge during the rulemaking process.

The specific objectives of RMT.0287 are to solve the consistency issues, fill the gaps identified through the implementation experience, and keep the requirements up to date with the new developments in the field of medicine in order to ensure that they are fit for purpose and can be implemented in practice.

The objective of RMT.0700 is to address the recommendations issued by the EASA-led Germanwings Task Force on the accident of the Germanwings Flight 9525 and the related safety recommendations issued by the Bureau d'Enquêtes et d'Analyses pour la Sécurité de l'Aviation Civile (BEA).

In summary, the proposed changes are expected to improve the level of safety by introducing new requirements:

  • to strengthen class 1 medical examination for applicants for and holders of certificates by including drugs and alcohol screening and comprehensive mental health assessment as well as improved follow-up in case of medical history of psychiatric conditions;
  • for aero-medical centres (AeMCs) and aero-medical examiners (AMEs) to report to the competent authority all incomplete medical assessments, thus preventing fraud attempts;
  • to increase the quality of the aero-medical examinations by improving the training, oversight and competency assessment of the AMEs; and
  • for the holders of medical certificates to return them to the licensing authority in case of suspension and revocation of their medical certificates.

Moreover, the proposed changes aim to ensure harmonisation between the requirements of Part-MED and Part ATCO.MED (Annex IV to Commission Regulation (EU) 2015/340). Finally, the changes proposed by this Opinion are expected to enhance clarity and consistency of rules in line with better regulation principles.