2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of the harmonised software components of an EHR system continue to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 36. Changes in EHR system design or characteristics with regard to the harmonised software components of an EHR system shall be adequately taken into account and reflected in the technical documentation.