(iii) recorded the results of the examination including, in the case of a person 35 years of age or older, the results of a stress ECG performance test on a treadmill or a bicycle, on a medical examination record in the form set out in Schedule VII or in another form acceptable to the Chief Safety Officer, and on a diver’s medical certificate in the person’s diver’s logbook;

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certifi ...[+++]cates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them.

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certifi ...[+++]cates issued by notified bodies, of the requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them.

1. In accordance with Article 15a(3), the Commission, after the mandatory consultation of the MDAC shall establish, by means of delegated acts, a list of medical devices or types of medical device which are unsuitable for reprocessing.

The Commission should be empowered to lay down, by means of delegated acts, rules concerning specific composition and information requirements for food intended for infants and young children and medical food.

(29a) To ease access of SMEs to the market which in some sectors, for example baby food and medical food, appear to be dominated by a few large companies, the Commission should, in close cooperation with concerned stakeholders, adopt guidelines, by means of delegated acts, in order to help undertakings, in particular SMEs, to comply with the requirements laid down in this Regulation and thus facilitate competitiveness and innovation.