Monitoring of Member States
Article 85
1. The Agency shall assist the Commission in monitoring the application by the Member States of this Regulation and of the delegated and implementing acts adopted on the basis thereof by conducting inspections and other monitoring activities. Those inspections and other monitoring activities shall also aim to assist the Member States in ensuring the uniform application of this Regulation and of the delegated and implementing acts adopted on the basis thereof and in sharing best practices. The Agency shall report to the Commission on the inspections and other monitoring activities conducted pursuant to this paragraph. 2. For the purposes of conducting the inspections and other monitoring activities referred to in paragraph 1, the Agency shall be empowered to: (a) require any national competent authority and any natural and legal person subject to this Regulation to provide the Agency with all necessary information; (b) require those authorities and persons to provide oral explanations on any fact, document, object, procedure or other subject matter relevant for determining whether a Member State complies with this Regulation and with the delegated and implementing acts adopted on the basis thereof; (c) enter relevant premises, land and means of transport of those authorities and persons; (d) examine, copy or make extracts from any relevant document, record or data held by or accessible to those authorities and persons, irrespective of the medium on which the information in question is stored. The Agency shall, where required for determining whether a Member State complies with this Regulation and with the delegated and implementing acts adopted on the basis thereof, also be empowered to exercise the powers set out in the first subparagraph in relation to any other legal or natural person who can reasonably be expected to possess or have access to information relevant for those purposes. The powers of this paragraph shall be exercised in compliance with the national law of the Member State where the inspection or other monitoring activities take place, with due regard for the rights and legitimate interests of the authorities and persons concerned and in compliance with the principle of proportionality. Where in accordance with the applicable national law prior authorisation from the judicial or the administrative authority of the Member State concerned is needed to enter relevant premises, land and means of transport as referred to in point (c) of the first subparagraph, those powers shall be exercised only after obtaining such prior authorisation. 3. The Agency shall ensure that the members of its staff and, where relevant, any other expert participating in the inspection or the other monitoring activity are sufficiently qualified and adequately instructed. In the case of inspections, those persons shall exercise their powers upon production of a written authorisation. In good time before the inspection, the Agency shall inform the Member State concerned of the subject matter, the purpose of the activity, the date on which it is to begin and of the identity of the members of its staff and any other expert carrying out that activity. 4. The Member State concerned shall facilitate the inspection or the other monitoring activity. It shall ensure that the authorities and persons concerned cooperate with the Agency. Where a legal or a natural person does not cooperate with the Agency, the competent authorities of the Member State concerned shall provide the necessary assistance to the Agency to enable it to carry out the inspection or other monitoring activity. 5. When an inspection or another monitoring activity conducted in accordance with this Article entails an inspection or another monitoring activity in respect of a legal or a natural person subject to this Regulation, Article 83(2), (3) and (4) shall apply. 6. Upon request of the Member State, reports drawn up by the Agency pursuant to paragraph 1 shall be made available to it in the official Union language or languages of the Member State where the inspection took place. 7. The Agency shall publish a summary of information about the application by each Member State of this Regulation and of the delegated and implementing acts adopted on the basis thereof. It shall include that information in the annual safety review referred to in Article 72(7). 8. The Agency shall contribute to the assessment of the impact of the implementation of this Regulation and of the delegated and implementing acts adopted on the basis thereof, without prejudice to the Commission's assessment under Article 124, having regard to the objectives set out in Article 1. 9. The Commission shall adopt implementing acts laying down detailed rules on the working methods of the Agency for conducting the tasks under this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 127(3).