REGULATION (EC) No 216/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
CHAPTER II - SUBSTANTIVE REQUIREMENTS

Article 4
Basic principles and applicability

1. Aircraft, including any installed product, part and appliance, which are:

(a) designed or manufactured by an organisation for which the Agency or a Member State ensures safety oversight;

Regulation (EC) No 216/2008 applies only to aircraft and aviation activities that are placed under the European aviation safety system, meaning aircraft whose design, production and continuing airworthiness are overseen by EASA or a Member State acting within the EU framework. Article 4(1)(a) defines the scope very clearly: The Regulation targets the “standard”, type-certificated aviation system and the organisations operating within it. Aircraft or operations that fall outside this system (such as experimental aircraft, very light recreational aircraft, or small unmanned aircraft that are regulated nationally) are not within the scope of this Regulation.

As for the other options:

aircraft designed or modified for experimental purposes, and to be produced in limited numbers. ---> INCORRECT. These aircraft are not part of the standard certification and oversight system addressed by the Regulation. They are handled outside the EU type-certification framework.

single and two-seater gyroplanes with a maximum take-off mass of up to 560 kg. ---> INCORRECT. Very light recreational aircraft are not part of the standard EASA certification system addressed by Regulation 216/2008.

unmanned aircraft with an operating mass of up to 150 kg. ---> INCORRECT. At the time of Regulation 216/2008, small unmanned aircraft were not regulated at EU level and therefore did not fall within the scope of this Regulation.