http://www.legislation.gov.uk/eur/2018/545/article/16Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)Commission Implementing Regulation (EU) 2018/545Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)2020-12-12King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02018R0545-20200616texttext/xmlen2020-06-16 CHAPTER 2 <Strong>PREPARATION OF THE APPLICATION</Strong> Changes to an already authorised vehicle Article 16 1 Changes to an already authorised vehicle which are linked to substitution in the framework of maintenance and limited to replacement of components by other components fulfilling identical functions and performances in the framework of preventive or corrective maintenance of the vehicle do not require an authorisation for placing on the market. 2 Any other changes to a vehicle shall be analysed and categorised in accordance with Article 15(1). 3 The entity managing the change shall request a new authorisation for placing on the market in accordance with Article 14(1)(d) when a change falls under Article 15(1)(d). 4 If the entity managing changes categorised in accordance with Article 15(1)(b) and (c) to an already authorised vehicle is not the vehicle type authorisation holder it shall: a assess the deviations from the technical files accompanying the EC declarations for verification for the subsystems; b establish that none of the criteria set out in Article 21(12) of Directive (EU) 2016/797 are met; c update the technical files accompanying the EC declarations for verification for the subsystems; d notify the changes to the authorising entity. This may apply to a vehicle or a number of identical vehicles. The authorising entity may issue, within 4 months, a reasoned decision requesting an application for authorisation in case of a wrong categorisation or insufficiently substantiated information. 5 Every change to a vehicle shall be subject to configuration management under the responsibility of the keeper or of the entity entrusted by it.