MEDICAL DEVICES
Medical technologies are products, services and solutions that are used to save or improve human lives. They have various forms and accompany a person at different stages of life, from diagnosis to treatment. The definition, which specifies what a medical device is, is part of the Medical Devices Act No. 268/2014 Coll.
The Medical Devices and Technologies brochure in a nutshell can be downloaded HERE .
INDUSTRY AS SIGNIFICANT INNOVATOR
The field of medical devices (ZP) is regulated by Directives No. 93/42/EC and 90/385/EEC. From 2021, the new Regulation No. 2017/745/EU will be fully applicable. Until then, manufacturers can choose whether to follow the Directives or the Regulation.
Classification of medical devices (estimated to be more than 500,000) requires both pre- and post-marketing to the market to meet many requirements. Considering the variety of products, the level of control is a third party (by a notified body) before placing it on the market, depending on the impact that the use of the product can have on the human body.
The same notified person continues to be involved even after the product has been placed on the market, in order to ensure safety and functionality of medical devices.
WHO ISSUES THE MEDICAL DEVICE
The product may only be dispensed by a dispenser who is a provider of pharmacy health care services, an optician or a person with whom a health insurance company has concluded a dispensing contract in accordance with the law governing public health insurance.
MEDICAL DEVICE REGISTRATION
You register your activity by reporting your activity/person dealing with medical devices. Once you have met these conditions, you can submit a notification request via the medical devices module in the Medical Devices Register.
eVOUCHER
The eVoucher (or electronic voucher for medical devices) is part of the ePrescription system. It has been in operation since May 1, 2022 and is optional for healthcare professionals and dispensing facilities.
MDR
The new Regulation (EU) 2017/745, or MDR (Medical Devices Regulation), is a European regulation on medical devices that defines the regulations and binding agreements that all manufacturers and distributors must comply with in order to place a medical device (MD) on the European market.
HTA
HTA (Health Technology Assessment) is a multidisciplinary process that collects and evaluates information on the medical, social, economic and ethical impacts of the use of health technologies. Its goal is to increase the effective capacity of the health system and maximize benefit within limited resources.