Manufacturing of medical devices may be carried out only by registered legal and natural persons, in accordance with the Law on medical devices.

Manufacturing of medical devices shall include the design, manufacturing, packaging and labeling, quality assurance system, storage, placing on the market and distribution of medical devices. The activity of the manufacturing of medical devices also include the sale of these products to legal entities that carry out wholesale of medical devices.

Registration of the manufacturer shall not be required for legal and natural persons who assemble or adapt medicinal devices of a specific intended purpose that are already on the market and are intended for a particular patient.

Manufacturing of medical devices shall be carried out in accordance with the established system of quality assurance of the medical device manufacturing, proven by the manufacturer by way of a certificate issued by the certified body.

Manufacturer shall manufacture medical devices in accordance with the essential requirements and the decision issued by the Institute. Manufacturer shall provide insurance against harmful effects that may arise when using a medical device, in accordance with the Insurance Law.

Manufacturer’s registration may refer to the entire process or parts of the process of a medical device manufacture. The decision on the manufacturer’s registration shall be issued for an indefinite period.

Manufacturer shall continuously supply the market with medical devices from its program in accordance with the decision on the registration of medical devices.

 Manufacturer must meet special conditions, as follows:

• to provide conditions in terms of space and equipment for the manufacturing of medical devices, in accordance with the essential requirements for the medical device whose manufacture he performs;
• to have at least one employee responsible for manufacture;
• to have at least one person responsible for quality and vigilance;
• to ensure that the medical device is designed in accordance with the essential requirements;
• to classify the medical device in the appropriate risk class, prepare the prescribed technical documentation and implement, or ensure the implementation of the applicable conformity assessment procedure;
• to issue a declaration of conformity, where applicable, and mark the medical device with a marking of conformity in accordance with the Law;
• to keep the technical documentation and the declaration of conformity after placing the medical device on the market for at least five years, and for implantable medical devices for at least 15 years;
• to have in place the procedures ensuring the maintenance of conformity of the medical device manufacture with the essential requirements and technical standards;
• to label the medical device and attach the instructions for use in accordance with the Law;
• to take the necessary corrective measures in the event of established non-conformity;
• for a medical device, except for a custom-made medical device or investigational medical device, to establish and maintain, and to keep proper records of non-compliant medical devices and those withdrawn from the market;
• to have a plan for the withdrawal of a medical device from the market;
• to keep records on the type and quantity of sold medical devices in Montenegro;
• to provide other conditions for the manufacture in accordance with the Law