The publication contains both the necessary interpretative statements based on the European MDCG documents and, above all, practical guidance on how to meet the wide range of new requirements. Almost 800 standard pages of text are supplemented by clear infographics (process maps, flow charts, tables, etc.), commentary on all articles of the regulation as well as all its annexes.
It will be especially appreciated by domestic manufacturers, importers and distributors of medical devices, as well as notified bodies, hospitals, pharmacies and medical device dispensers.
The publication is published by Porta Medica, co-published by the Czech Agency for Standardization. If you are interested, you can order the commentary now at a discounted price in the pre-sale via the Erudikum e-shop, which distributes the here.
We would like to inform you that the Czech Agency for Standardization is organizing a three-year qualification course on the EU Medical Device Regulation 2017/745 (MDR) and EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), which will take place between January 2022 and December 2024.
Porta Medica is the supplier of this six-semester course, which is intended for regulatory personnel of medical device manufacturers and other operators handling medical devices. The focus and scope of the course is not intended for representatives of educational and consulting companies, students or academics. The course is implemented on the basis of requests and suggestions from industry associations and with the support of the Ministry of Industry and Trade.
Participation in the course is free of charge. Only the fee of 990 CZK excluding VAT for additional services per person per day of training, conference or seminar is payable. The MDR and IVDR areas are separate in the course. The professional attends either the MDR or the IVDR course.
If you are interested, please send the completed application form in machine-readable form (MS Word or a copyable PDF, not a scan), separately for each participant to jana.kazdova@portamedica.cz
The total number of participants is limited to a maximum of two professionals per company. Applicants will be placed on the course in order of date and time of application.
CAS course - IVDR - application
CAS course - IVDR - invitation
CAS course - MDR - application
On Friday 17 September, a new publication "Guide to the regulatory rules for electric wheelchairs" was launched, which aims to make it easier for consumers to make the right choice of electric wheelchair, but also to help manufacturers, importers and distributors to put these products on the market. The handbook was christened by Deputy Prime Minister and Minister of Industry, Trade and Transport Karel Havlicek and Chairman of the National Council of Persons with Disabilities of the Czech Republic Václav Krása.
The publication was produced in cooperation with the National Council of Persons with Disabilities of the Czech Republic, the Ministry of Industry and Trade, the Office for Technical Standardization, Metrology and State Testing, the Czech Trade Inspection, the State Institute for Drug Control and the Ministry of Transport.
The thirty-page material will help people with disabilities, but also, for example, seniors with the purchase of a suitable electric wheelchair, of which there is a large number on the market, but not all of them meet the necessary technical parameters, so it will become one of the tools in the fight against unfair practices of some traders. The next part of the guide is dedicated to manufacturers, importers and distributors.
The publication is unique in that it is the first manual of its kind in the Czech Republic that provides a comprehensive overview of regulatory standards and related interpretation from the perspective of consumer protection, public health insurance funding, or the use of electric wheelchairs on roads.
The guide will be distributed both in print and electronically and will be available for download on the websites of all collaborating organisations.
The publication can be downloaded here: Regulatory guide for electric trolleys
You can watch the launch of the publication on https://youtu.be/hLzHNePZ8A4
Prague, 9 March 2021
A simple information leaflet with instructions on how to choose the right respirator has been prepared for consumers by the Office for Technical Standardization, Metrology and State Testing (ÚNMZ). The leaflet follows the demand and the recently published publication "A guide to the basics of personal protective equipment and medical devices regulation", which was welcomed by hospitals, social service providers, cities, municipalities and other entities.
The one-page material aims to guide the general public through the purchase of respirators in a clear way so that consumers purchase functional and safe respiratory protection products. Always, of course, with the necessary European certification to confirm the necessary quality and effectiveness.
"The recently published guide with about 70 pages was intended for moderately knowledgeable readers of the subject. We have received suggestions and requests from many parties to create as concise and clear a manual as possible for the general public who are lost in the details and do not know what to look for when buying a respirator and what parameters to check. Thus, the idea of a one-page graphic manual with a brief but clear summary of all the important information was born." says Viktor Pokorný, chairman of the ÚNMZ.
The necessary simplification is a tribute to the maximum clarity of the leaflet. If someone wants to know in detail the formal requirements for the correct labelling of respirators, the above guide is more suitable. The leaflet is a basic reference guide for consumers when making actual purchases and is not intended to be used to back-check the adequacy of respirators purchased, for example, last spring when a number of emergency exemptions were in place and properly certified CE marked respirators were in desperate short supply on the market.
"Our goal is not to say which respirators are better quality, who sells illegal products or even fakes. Together we have created a fictitious respirator called "Pepa", which we are trying to show the ordinary consumer what basic information must be on the respirator and its packaging if it is to meet the European standard," adds Jakub Král from the educational and consulting company Porta Medica, which participated in the preparation of the leaflet.
The information leaflet will be distributed to the general public. There will be an online version that can be shared free of charge on the web, social networks, etc. A printed version will be available at publicly accessible places in hospitals, offices, pharmacies or public transport.
The information leaflet can be downloaded here: I have the right respirator
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
3 July
The Office for Technical Standardization, Metrology and State Testing (ÚNMZ) announces that due to the planned reconstruction of the building Biskupský dvůr 1148/5, Prague 1, it is moving to new premises at Na Žertvách 132/24, Prague 8 with effect from 3 August 2020. All telephone numbers and e-mail addresses remain unchanged.
The relocation work will take place between 24 and 31 July 2020 and therefore normal operations cannot be guaranteed. The Office will be fully operational on 3 August 2020.
The ÚNMZ office is now located at: Na Žertvách 132/24, Prague 8;
The seat of the ÚNMZ remains unchanged: Biskupský dvůr 1148/5, Prague 1;
The billing address and registered office for official documents (contracts, etc.) must always be provided: Biskupský dvůr 1148/5, Prague 1;
Please use the following address as your mailing and shipping address for all correspondence (including invoices, etc.): Na Žertvách 132/24, Prague 8;
Together with the ÚNMZ, the new address Na Žertvách 132/24 will be moved to Czech Agency for Standardization, which is based in the same building at 1148/5 Biskupský dvůr. The reconstruction of the building is planned to take 2 years. After that, both entities will move back to their registered office address.
Thank you for your understanding
Mgr. Viktor Pokorný
President of the ÚNMZ
The Office for Technical Standardization, Metrology and State Testing (ÚNMZ) will start using a new form of a uniform visual style from 24 February 2020.
The new logotype is easy to identify and remember. It consists of the visual part of the symbol and the text part of the name of the office. However, the symbol can also be used on its own. " The main motif of the logo is the symbol of a gear, which is a basic structural component of gearboxes and other machines, mirrors the technical focus of the Office and thus emphasizes our mission to ensure the tasks arising from the laws of the Czech Republic governing technical standardization, metrology and state testing and tasks in the field of technical regulations and standards applied within the framework of the Czech membership in the European Union" says Mgr. Viktor Pokorný, chairman of the ÚNMZ.
The existing logo has been used by the ÚNMZ since 1993. Its design is outdated in terms of the identity and communication of the office and does not correspond to current standards. The Office expects the new brand to become an effective tool for communication with target groups and to better present the Office in the Czech Republic and abroad.
Along with the new logo, the ÚNMZ is also launching a new website. "When creating them, we put emphasis on simplicity, clarity and better orientation in the services offered to the visitor of the site" adds Viktor Pokorný.
We believe that the new identity will be perceived positively and will serve the Authority for many years to come.
Thematic headings:
- UK government's Brexit preparations on standardisation
- Brexit and the relationship between the UK and the EU, BSI's view on Brexit
- BSI in CEN and CENELEC after Brexit
- The impact of Brexit on the free movement of goods and services (conformity assessment, certification, mutual recognition, etc.) from BSI's perspective
- UK industry's views on Brexit-related issues
Organizer: Czech Agency for Standardization s.p.o.
Patronage: Chamber of Commerce of the Czech Republic
Deadline: March 5, 2020, 9:00 a.m. - 2:00 p.m.
Venue: Chamber of Commerce of the Czech Republic, Florentinum, Na Florenci 2116/15, 110 00 Prague 1
Program:
9:00 - 9:30 attendance of participants
9:30 - 9:45 Opening, opening remarks
9:45 - 11:45 Block I.
Speaker:
Fergus McReynolds, Director of EU Affairs, Make UK
Daniel Mansfield, Head of Policy Engagement, BSI
Richard Collin, Head of European and National Policy, BSI
11:45 - 12:15 break, refreshments
12:15 - 14:00 Block II
panel discussion (space for your questions sent in advance via the registration form).
Simultaneous translation provided!
Participation is free, you must register in advance at http://www.agentura-cas.cz/brexit
If you have a specific question for a BSI representative, please specify it on the registration form when you register and we will try to include it in the panel discussion agenda.