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MDR - IVDR Consultancy

TCE's IVDR solutions cover a range of services aimed at ensuring compliance with the In Vitro Diagnostics Directive. The Institute offers training courses focusing on the implementation of the IVD Directive and the requirements of the IVDR, enabling organizations to efficiently deploy IVD devices on the European market and create technical documentation to support products throughout their lifecycle. In addition, by providing end-to-end ecosystem solutions for IVDR compliance, TCE aims to identify deficiencies or requirements in each product and related processes based on regulations and determine the roadmap for businesses and MDR-IVDR compliance of each product. The Institute's expertise in ISO 13485, risk analysis, clinical evaluation, R&D, verification and validation, design and development, regulatory and product launch forms the basis of its comprehensive approach to IVDR compliance and support to organizations in the in vitro diagnostics sector.

Traceability

In vitro diagnostic devices (IVDDs) are subject to stringent traceability requirements under the In Vitro Diagnostics Regulation (IVDR). This regulation places a strong emphasis on the need for an effective quality management system (QMS), highlighting the importance of a life cycle approach and continuous evaluation of products. One of the key features of IVDR is the introduction of a system of unique device identifiers (UDIs) to improve the identification and traceability of IVDDs.

This system provides clear identification of each device and its components throughout the supply chain, from production to distribution and use. Traceability measures, including the assignment of UDIs, are necessary to ensure the safety and performance of IVDDs and to enable rapid and accurate recall of devices in the event of security issues or defects. IVDD manufacturers are required to comply with these traceability provisions and integrate them into their technical documentation and quality management systems to ensure full compliance with the IVDR.

MDR SOLUTIONS

This Regulation aims to ensure the smooth operation of the internal market for medical devices, based on a high level of health protection for patients and users and taking into account small and medium-sized enterprises operating in this sector. This Regulation also sets high quality and safety standards for medical devices.

The Medical Devices Institute offers a comprehensive range of services and solutions to support compliance with the Medical Devices Directive (MDR) and other relevant standards. The services we offer include training courses focusing on the implementation of MDR requirements, as well as expertise in areas such as ISO 13485, risk analysis, clinical assessment, research and development, regulatory approval and product launch. Our solutions are designed to enable companies to overcome the complexity of MDR compliance and ensure the quality and safety of their medical devices.

Analysis

Excopan analysis service includes identifying deficiencies or requirements of all products and processes, on-site or digitally, using regulations. It determines the roadmap for your business and the MDR-IVDR compliance of each product with a short report file.

UDI (UNIQUE DEVICE ID)

The unique code increases the traceability of devices and makes a possible recall quick and effective for products detected as safety hazards.

Under the new rules, any manufacturer will assign a UDI to all its high-end packaging and the device before placing it on the market. The UDI carrier should be placed on the label of the device and on the upper levels of the package.

Following a call for applications launched at the end of 2018 and Commission Implementing Decision (EU) 2019/939 of 6 June 2019, four regulatory bodies were selected to provide manufacturers with a list of UDIs to assign to medical devices.

If you operate in the medical device industry, it is vital that you comply with the MDR (Medical Device Directive) and IVDR (In Vitro Diagnostic Devices Directive). Complying with these complex regulations can be difficult and time-consuming. This is where the Medical Devices Institute comes into play.

As the Medical Devices Institute, we have a team specialized in MDR and IVDR consultancy, thanks to our EXCOPAN partnership. Our experts have many years of experience in the medical device industry and have an in-depth knowledge of all regulatory requirements.