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Enhancing Quality Infrastructure for Medical Technologies in the EU: Precision, Safety, and Innovation

  • Writer: Dr. Ulrich Harmes-Liedtke
    Dr. Ulrich Harmes-Liedtke
  • Dec 13, 2024
  • 6 min read

Updated: Apr 17

By Ulrich Harmes-Liedtke, Ozan Aykurt and Folker Spitzenberger


The European Union is at the forefront of medical innovation, supported by a robust regulatory framework that ensures medical technologies’ safety and performance while actively supporting their quality and efficacy.


In recent years, however, this strict regulatory framework has led to high levels of bureaucracy for manufacturers, which could hinder innovation rather than encourage it. This underscores the importance of refining regulatory processes within the framework of the regional quality infrastructure (QI) system. A streamlined and efficient QI is crucial in a field that spans everything from AI-enabled to life-saving surgical medical devices.


Metrology, standardization, conformity assessment, and accreditation together create a foundation that supports the seamless introduction of innovative medical technologies into the healthcare market.


Standardization and regulation

Standardization efforts across the EU provide a common language for medical technology manufacturers and regulators. To validate the accuracy of tools and processes, laboratories adhere to rigorous standards like EN ISO/IEC 17025 for testing and calibration laboratories and EN ISO 15189 for medical laboratories.


Guided by frameworks such as the Regulation (EU) 2017/745 (EU Medical Device Regulation, MDR) [3] and Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR) [4], standards harmonise product development and ensure compliance with stringent safety requirements. Institutions like Fraunhofer IMTE and Centre for Regulatory Affairs in Biomedical Sciences (CRABS) at the University of Applied Sciences Lübeck (Technische Hochschule Lübeck) contribute to these efforts by supporting the development of standards for emerging technologies, such as artificial intelligence and digital health applications, ensuring they meet both technical and regulatory demands.


The quality management standard for the design and manufacture of medical devices ISO 13485 and the application of risk management to medical devices under EN ISO 14971 are relevant to medical device manufacturers.


Reliable measurements for medical technologies

Metrology plays a critical role in ensuring the precision of measurements essential for diagnostics and the performance of medical devices. These measurements are fundamental in clinical settings, where even the slightest inaccuracies can significantly affect patient outcomes.


A notable example of metrology in action is the support provided by the Physikalisch-Technische Bundesanstalt (PTB), Germany’s National Metrology Institute. [1] PTB is crucial in ensuring accurate and reliable measurements for medical technologies, contributing directly to patient safety and device efficacy. PTB is also involved in research and innovation in medical measuring instruments.


One example is the research and development activities in analysing blood samples in laboratory medicine. In a flow cytometer, blood cells are injected from a sample suspension into a capillary and are usually focused by a sheath flow. They are collected and analysed individually and sequentially in the focus of a laser beam at high throughput. The cells analysed this way cannot usually be used for further analyses due to the high dilution caused by the sheath flow. 


PTB has developed a novel flow cytometer designed explicitly to overcome this problem and enable measurements on the same undiluted sample aliquots. The instrument uses syringes, acoustic focusing and an open fluidic system to collect and reuse undiluted samples. The cytometer is compact and reduces sample consumption. It detects both forward and side-scattered light signals as well as fluorescence signals. It is designed to allow additional downstream analysis of cells, for example, by mass spectrometry, magnetic resonance spectroscopy or other analytical methods.

By providing traceable measurement standards and expertise, PTB underpins the entire value chain, from the development of medical technologies to their clinical application.


Calibration of low-cost mechanical ventilators in Latin America

During the COVID-19 pandemic, PTB’s International Cooperation supported the metrological traceability of newly developed low-cost mechanical ventilators in Latin America. In the past, metrology institutes had expanded their measurement capacities for high gas flow pressures and large volumes. Still, they did not have sufficient experience in measuring low-pressure gas flows and tiny volumes. The cooperation with PTB helped develop the ventilators’ calibration procedures, enabling manufacturers to produce devices that meet regulatory standards while ensuring user and patient safety.[2]



A low-cost respirator was developed by Argentine companies with INTI support. Source: INTI
A low-cost respirator was developed by Argentine companies with INTI support. Source: INTI

Trust building by conformity assessment, notification and accreditation

Conformity assessment and accreditation are equally crucial in maintaining trust in medical technologies. These assessments confirm adherence to regulations and result in CE marking, signifying that the device is fit for use across EU member states. 


Notified Bodies evaluate devices for compliance with essential safety and performance standards. They are designated by the responsible regulatory and surveillance authorities and often must be accredited to ISO/IEC 17021-1 (management systems certification) or ISO/IEC 17065 (product certification) to demonstrate:

  • Technical Competence: Assurance that they understand the complex regulatory requirements for medical devices.

  • Impartiality: Neutrality in the evaluation process, critical for trust in the certification.

  • Harmonized Standards: Ability to apply consistent criteria globally, supporting international trade and compliance with frameworks like the EU Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).

For example, in the area of vitro diagnostic medical devices (IVDs), blood glucose monitors, pregnancy test kits, and COVID-19 diagnostic tests are products that need to be certified by an accredited laboratory.


Regulation and authorisation for safe and effective devices

Regulation and conformity assessment procedures ensure that only safe and effective devices enter the EU market. The EU MDR and EU IVDR require comprehensive technical documentation and clinical evidence to demonstrate compliance. For innovative products, organisations like Fraunhofer IMTE and Centre for Regulatory Affairs in Biomedical Sciences (CRABS) at the University of Applied Sciences Lübeck (Technische Hochschule Lübeck) guide manufacturers through these complex pathways, assisting with everything from regulatory strategy development to submission of documentation to Notified Bodies. Once devices are CE marked, post-market activities like clinical follow-ups and performance monitoring ensure ongoing compliance and safety.


Academic training programs

In preparing the next generation of experts to support and expand QI in the medical technology sector, academic programs like those offered at the University of Applied Sciences Lübeck (Technische Hochschule Lübeck) play a vital role. The University’s Master’s in Regulatory Affairs (MRA) program equips students with the interdisciplinary knowledge to navigate complex regulatory environments. Focusing on clinical, regulatory, and quality management aspects, this program provides a foundation for understanding EU MDR and IVDR compliance, preparing graduates to take on roles in industry, regulatory bodies, or research. The University also offers programs in Applied Natural Sciences, which provide a strong basis in science and technology, fostering innovation in medical technology development.


Challenges and outlook

While the EU’s QI is robust, the rapid pace of innovation presents ongoing challenges. Developing agile standards and conformity assessment processes is essential for emerging technologies like Computational Modelling and Simulation (CMS). Increasing the capacity and expertise of Notified Bodies is necessary to handle the growing complexity of medical devices. Enhanced post-market surveillance using digital tools will enable better risk detection and mitigation. Moreover, harmonising EU standards with global frameworks can streamline market access and compliance.


This outlook underscores the importance of European QI systems for developing and newly industrialising countries. Many of these nations aim to participate in the global medical technology market as exporters to the EU or to improve user and patient safety domestically. Manufacturers must align with European standards to export medical technologies to the EU, undergo conformity assessments, and secure CE marking. To ensure compliance with EU requirements, these countries must establish equivalent QI systems, including metrology institutes, accreditation bodies, and regulatory frameworks.

Developing and emerging nations also need robust QI systems for patient safety within their borders. By adopting internationally recognised standards and market approval practices, they can ensure the performance and safety of imported and locally produced medical devices. Building partnerships with established QI institutions in Europe can help transfer knowledge and accelerate the development of these systems. Ultimately, aligning with European QI practices benefits the countries and strengthens the global medical technology ecosystem, fostering innovation and safeguarding public health worldwide.


References

[2] Göthner, Karl-Christian (2023) Strengthening the Metrology Infrastructure to Support Medical Testing Equipment, In Candela Blog, 6.9.2023, https://candela-ptb.de/strengthening-the-metrology-infrastructure-to-support-medical-testing-equipment/

[3] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0745

[4] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746&qid=1732982354573


Co-authorship and ressoruce persons

Prof. Dr. sc. hum.Dipl.-Chem. Florian Spitzenberger is Head of Regulatory Affairs for Medical Devices at the Technical University of Lübeck and Group Leader Clinical & Regulatory Affairs, Fraunhofer Research Institution for Individualised and Cell-Based Medical Engineering IMTE


Ozan Aykurt, M.Sc., is a research associate at the Centre for Regulatory Affairs in Biomedical Sciences (CRABS) at Lübeck University of Applied Sciences and the Clinical and Regulatory Affairs (CARA) division of the Fraunhofer Research Institution for Individualised and Cell-Based Medical Engineering IMTE


Many thanks to Dr Esmeralda Valiente, Head of Department 8.3: Biomedical Optics/ Biomedical Optics and Tobias Diergardt from PTB’s International Cooperation for the information on this article. 

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