Manufacturers of medical devices
A manufacturer of medical devices is a legal or natural person with responsibility for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The manufacturer must:
- ensure that the medical device that he manufactures has been designed and manufactured in accordance with the requirements provided by the Medical Devices Act (Official Gazette no. 76/13),
- classify the medical device into the appropriate risk class, draw up the relevant technical documentation and conduct or ensure the conduct of an applicable conformity assessment procedure for the medical device concerned,
- draw up the conformity declaration and affix the CE marking to the medical device in question,
- keep available the technical documentation and the conformity declaration for at least five years after the medical device has been placed on the market,
- ensure the procedures with the view to pertaining the conformity of the batch or serial,
- properly label and mark the medical device and supplement it with the instructions for use referred to in Article 12 of the Medical Devices Act (Official Gazette no. 76/13),
- undertake corrective actions where it can be assumed or where there is a reason to believe that the medical device which has been placed on the market does not comply with the provisions of the Act,
- be insured against harmful effects which might occur by the use of the medical device.
The responsibilities of the manufacturer of a medical device refer both to a legal and a natural person who assembles, packages, processes, refurbishes and/or labels medical devices with a view to their being placed on the market under his own name.
Any manufacturer who assembles and places on the market medical devices bearing the CE marking, as a system or procedure pack, in accordance with their intended purpose and within the limits of use specified by their manufacturer, must make the following declaration:
- that he has verified the mutual compatibility of the medical devices and has carried out his operations in accordance with the manufacturer’s instructions,
- that he has packaged the system or procedure pack and supplied instructions for its use to users incorporating relevant instructions from the manufacturers,
- that the whole activity is subjected to appropriate methods of internal control and inspection.