MDR certifikace

MARIE PACS is MDR certified

The company OR-CZ has long been developing, supplying and servicing the certified medical device MARIE PACS, software for electronic processing, archiving and distribution of image data in healthcare, in higher risk class IIb.

MARIE PACS and MDR certification

The highest priority strategic goal for 2023 was the transition of the MARIE PACS medical device from MDD to MDR certification, which completely changed the legislation governing the manufacture, distribution and use of medical devices as of 21 May 2021. As required, the MARIE PACS lifecycle had to undergo both practical adjustments and accompanying administrative changes in the technical and system documentation of the medical device.

The technical file of a medical device, as a set of information, documents and evidence, is one of the two mandatory administrative components for the purpose of demonstrating in the regulatory process that a marketed product is safe, of good quality, meets its intended use and thus fulfils all legislative requirements.

One of the major changes has just involved a complete restructuring of the established and maintained technical component of MARIE PACS, which included, for example, the implementation of a new more detailed clinical assessment.

The changes also affected a second mandated area, namely the quality management system, which documents all processes in the company, among other things in accordance with the requirements of the MDR Regulation and according to EN ISO 13485 (standard describing the quality management system for medical devices). New requirements have been introduced for registration in EUDAMED (European Database of Medical Devices) or marking of the medical device (UDI codes, as a unique identification of the device), or a more detailed structured arrangement for the monitoring and evaluation of complaints about the medical device before and after marketing.

The existence, level and veracity of the technical documentation and related system documentation can be checked by the competent authorities. In the Czech Republic, this is the SÚKL (State Institute for Drug Control). In case of finding deficiencies in the technical or system documentation, there is a risk of heavy fines and in extreme cases, the manufacturer is obliged to withdraw the affected products from the market.

Granting certification is a financially demanding, time-consuming and risky path, which OR-CZ has successfully completed without non-compliance. By obtaining the certification of the MARIE PACS medical device in risk class IIb, OR-CZ Ltd. as a manufacturer declares compliance with the requirements of Regulation (EU) 2017/745 on medical devices and, last but not least, that the MARIE PACS is an effective and safe medical device for both patients and its operator.

MDR devices

Certifications declare to existing and potential customers the maintenance of high quality and safety standards of our products. They must comply with the ever-changing legislation, especially in eHealth as a modern concept that applies information and communication technologies to improve/accelerate prevention, diagnosis, treatment or even to promote public health.

If a medical device manufacturer wishes to introduce or continue to supply a product on the EU market, it must undergo a strictly supervised certification process, culminating in the obtaining of an "EU Quality Management System Certificate" with the determination of the classification class of the device, according to the rules set out in the MDR Regulation. The validity of the certificate is set at 5 years and is subject to the performance and positive results of regular annual surveillance audits. After the expiry of the period and in the case of unchanged legislation, a recertification audit will follow in order to extend the certification.