S.L. 458.59 Art. 2Interpretation. Cap. 458. Cap. 458. Cap. 465. Cap. 465. 2 [S.L. Cap. 465.

For the purposes of these regulations, unless the context otherwise requires:

"Act" means the Medicines Act;

"authorisation" means the approval given by the competent authority or any other authority as may from time to time be prescribed;

"competent authority" means the Medicines Authority as established under article 4 of the Medicines Act;

"economic operator" means a manufacturer, an authorised representative, an importer or a distributor of medical devices;

"medical device" means any medical device as defined in paragraph 1 of Article 2 of Regulation (EU) 2017/745, and any in-vitro diagnostic medical device as defined in paragraph 2 of Article 2 of Regulation (EU) 2017/746 and shall include any product designated as such by the competent authority;

"Minister" means the Minister responsible for public health;

"premises" means the location of the storage of medical devices and in-vitro medical devices;

"public health" and "public health emergency" shall have the same meaning as assigned to them by article 2 of the Public Health Act;

"public health risk" shall have the same meaning as assigned to it by article 2 of the Public Health Act;

"medical device registered person" means any person who is responsible for medical devices in terms of regulation 6; MEDICAL DEVICES PROVISION ON THE MALTESE 458.59 MARKET

"national medical device database" means the collection of data or other materials in relation to medical devices which are arranged in a systematic or methodical order and which are individually accessible by electronic or other means;

"non-conforming medical device" means any medical device that does not fulfill its specified requirements as required by or under these regulations or any other law;

"superintendent" means the Superintendent of Public

Health as established by article 3 of the Public Health Act.