The Medical Device Regulation (MDR), i.e., the Regulation of the European Parliament and of the Council on medical devices that will replace the previous Directive on medical devices (Medical Devices Directive, MDD) from May 26, 2021.
The main objective of MDR is to introduce reliable, transparent, foreseeable and fixed legal framework for medical devices, ensuring high level of safety and health, while supporting innovations. These objectives are implemented by enhancing requirements in many areas, for example, those concerning documentation at the device preparation stage, increasing the emphasis on obtaining feedback from Customers (also for further improvement of the devices) and ensuring product traceability throughout the supply chain.
Additional information on MDR regulations can be found, for example at a website of one of our certifying companies.
The state-owned enterprise Toruńskie Zakłady Materiałów Opatrunkowych is established and starts production of simple medical devices and personal hygiene products
The company is transformed into a joint-stock company TZMO SA by natural persons - company employees and representatives of the academic and medical circles
TZMO SA is the first company in Poland to be awarded a Good Manufacturing Practices (GMP) certificate confirming that medical devices produced by TZMO SA meet World Health Organisation (WHO) standards
TZMO SA as the first company in Poland in the medical industry that is granted a right to mark its devices with the European safety mark, CE, in accordance with the requirements of the MDD Directive, which came into force at that time
The European Union issues a new MDR Regulation, and information about it is available in the European Commission schedule or at the European Commission information website. The TZMO Group starts to prepare for full implementation of the MDR, with participation of high class specialists employed at our design offices, technological departments and R&D departments, at our factories, and at experienced conformity assurance and quality management teams, as well as at our European distribution network.
From May 26, 2021,
The MDR Regulation shall fully apply. The TZMO Group confirms it is completely ready for the new Regulation. As a company with nearly 70 years of experience in the medical industry we will ensure the complete conformance to MDR bearing in mind the needs of our Customers.
Each Patient and User of medical devices under TZMO SA brands:
wound dressing materials, such as drapes, swabs, surgical sets, and dressings
absorbing materials and other specialist medical devices to be used as protection for incontinence
absorbing devices to be used as protection for incontinence
after May 26, 2021, when MDR shall fully apply, they can feel even safer, due to numerous solutions and improvements, such as :
- product safety is our highest priority from the very beginning of the product life, i.e., already during its designing
- we collect feedback about our devices more effectively, using the latest IT technologies and the extensive network our trade partners and distributors
- we ensure traceability of our medical devices throughout the supply chain
- we implemented a new clear system for making medical devices on their packaging: “medical device” or [MD]
- we are ready to perform our obligations related to registration of the devices in the EUDAMED system
- already we are implementing unique UDI codes guaranteeing device traceability, although under MDR we have time to do this up to 2025 (depending on the device class)
From May 26, 2021,:
- medical devices under TZMO brands will be placed onto the market under new declarations of conformity, confirming that they meet the requirements of the MDR Regulation,
- medical devices under TZMO brands of the following classes: I sterile, IIa, IIb, and III, will be placed on the market under CE certificates issued by TÜV Nord and valid to July 9, 2023, confirming conformance with the requirements of the MDD Directive and declarations of conformity with the MDD Directive.
The processes of medical devices designing, production, sales and distribution are covered by the TZMO SA certified quality management system conforming to the requirements of the following standards: :
- ISO 9001:2015, certificate No. PL008673/P (issued by Bureau Veritas Polska Sp. z o.o.)
- ISO 13485:2016, certificate No. 283504-2019-AQ-POL-FINAS (issued by DNV GL Business Assurance Finland Oy Ab).