A guide to the basics of personal protective equipment and medical devices regulation
Prague, 16 February 2021
For more than a year now, the whole world has been dealing with the pandemic of the covid-19 disease. "A guide to the basics of personal protective equipment and medical devices regulation" to raise awareness of the correct marketing of products. This is the only way to ensure that healthcare workers and other frontline workers, teachers, other key professions, ordinary consumers and, of course, patients receive and use only safe, functional and effective personal protective equipment and medical devices.
"In 2020, we have seen a very strong demand for a comprehensive educational text that explains in a concise and understandable way to suppliers, buyers in various organizations, and the general public the full basics of product regulation that are necessary to combat a pandemic," says Viktor Pokorný, chairman of the ÚNMZ.
As a guide, the publication introduces domestic manufacturers to the main obligations when placing functional and safe devices on the market and guides them through the complex process of conformity assessment. Equally, it is a tool for the procurement department of various organisations that have to purchase personal protective and medical equipment in bulk without having any previous experience of procuring these products.
"For the Czech healthcare industry, the coronavirus pandemic represents a great threat on the one hand and a great opportunity on the other. The publication of the ÚNMZ, which is part of the Ministry of Industry and Trade, can help it significantly. I am delighted about it, it is an important guide for all domestic manufacturers, it will help them with the proper marketing of medical and personal protective equipment," Karel Havlíček, Deputy Prime Minister and Minister of Industry and Trade, adds his view on the guide.
Positive feedback is also coming from representatives of the Czech medical industry. "The ÚNMZ Guide is an extraordinary achievement at a time of great confusion and lack of much needed education. I have very much welcomed the production of this specialist publication which explains the full basics of regulation and the requirements involved in a clear and very practical way. Understanding it can help ensure that only quality and effective products reach Czech consumers, so that none of our health is put at risk," adds Jana Vykoukalová, chairwoman of the Association of Manufacturers and Suppliers of Medical Devices.
The publication also responds to calls from legislators, with whom the Ministry of Industry and Trade has agreed on the need to develop a practical methodology dealing with the requirements for medical devices and personal protective equipment. "There is no doubt that the segment of manufacturers and suppliers of products needed to combat the covid-19 pandemic is a strategic industry with high added value. The guide provides an important compass for the right path to market for their products," says Jan Dejl, Deputy Minister of Industry and Trade, under whose responsibility the ÚNMZ falls.
The efforts to improve legal awareness in the marketing of the products concerned are also welcomed by the State Institute for Drug Control (SÚKL), which supervises the medical device market in the Czech Republic. "The authors of the publication have managed to balance the necessary theoretical basis with a large number of illustrative examples from real practice. I also find the manuals for easy detection of illegal products on the market very useful." says Irena Storová, Director of SÚKL.
The requirement to have only safe and effective medical and personal protective equipment on the market in the Czech Republic is crucial, especially for frontline healthcare workers. They are totally dependent on the quality of such products. "In the context of Notified Persons for medical devices in the Czech Republic, the medical and technical community has gained a basic insight into the complexities of the conformity assessment process and the legal marketing of medical devices. This enforced experience has opened all of our eyes to the complexity of, for example, certification, clinical trials or the implementation of a quality management system. It is for this reason that I was very pleased when I was given the opportunity to learn about this guide from the IHRA and Porta Medica," says Professor Jiří Beneš, member of the Board of the Czech Medical Society JEP.
A team of experts from the educational and consulting company Porta Medica has contributed to the professional development of the publication. "It was an honour to be part of this educational and beneficial project. I very much appreciate the fact that even in the current hectic times, the Ministry of Industry and Trade, as well as the Ministry of Industry and Trade, do not forget that public administration should be primarily a service to citizens," concludes Jakub Král, founder of Porta Medica.
The guide will be published in printed form in a print run of 10,000 copies, which will be distributed free of charge to a wide range of recipients, from hospitals to social service providers, state authorities, regions and municipalities with extended powers. The online publication is also available on the websites of the Ministry of Health, the Ministry of Industry and Trade and Porta Medica for free use by the general public.
The publication is free to download here:
PUBLICATION GUIDE TO THE BASICS OF OOP AND ZP REGULATION
Full press release:
New publication of the Ministry of Public Health to help fight the covid-19 pandemic