Ricard Barberà i Guillem, José Serrano Ortiz, Víctor Primo Capella, Laura Martínez Gómez, Carlos M. Atienza Vicente
Instituto de Biomecánica (IBV). Universitat Politècnica de València. Edificio 9C. Camino de Vera s/n. Valencia (Spain)
The implementation of the new European Medical Devices Regulation (MDR) has caused a minor revolution in the sector that has required a major effort on the part of companies to adapt to this new framework. The Instituto de Biomecánica (IBV) provides advice on the development, evaluation and certification of medical devices to companies in the HEALTHCARE sector that are committed to the quality and safety of their medical devices as elements of brand identification. One such company is ECOPOSTURAL, a leading company in the field of healthcare furniture, which was granted a manufacturing license by the AEMPS (Spanish Agency for Medicines and Medical Devices) in 2001.
The objective of the collaboration between the Instituto de Biomecánica (IBV) and ECOPOSTURAL was the joint preparation of documentation included in the Technical File that is required by the new medical device regulations, covering everything from the description and classification of the product to the justification and explanation of the design and manufacturing process, without forgetting clinical evaluation, risk analysis, or the post-marketing system it applies to its line of stretchers. To this end, the IBV has made available to the company all the knowledge it possesses in the certification, development and evaluation of class I, IIa IIb and III medical devices.
On May 26, 2021, the new Medical Devices Regulation (EU) 2017/745 (MDR) came into force in the European Union as a result of work carried out by the Member States and the European Commission in collaboration with the sectors involved in medical devices. This regulation, published on April 5, 2017, amends Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.
The aim of this regulation is to ensure the market availability of effective, high-quality and safe medical devices. Some of the most important new features it introduces include improved product traceability, the creation of a large database to ensure transparency, and stricter requirements for preclinical and clinical data. Table 1 shows the most important new features with respect to the previous European medical device directive, 93/42/EEC.
As part of the collaboration between the IBV and ECOPOSTURAL in the preparation of the documentation included in the Technical File, the company’s entire range of stretchers has been analyzed, grouping them by similar characteristics and performance. Risk analysis was carried out for each of the groups and the appropriate treatment of these risks was justified. ECOPOSTURAL’s continuously stringent requirements in terms of the characteristics of the materials and components it sources from second-party suppliers, a policy implemented from the outset, and the performance of regulatory tests through the auspices of the IBV are aspects that allow the company to reduce risks and ensure the maximum quality of its products.
Figure 1. Overload test.
ECOPOSTURAL stretchers have been tested in IBV laboratories following test procedures adapted to UNE-EN 60601-2-52:2010/A1:2015, Electromedical equipment. Part 2-52: Specific requirements for basic safety and essential performance of hospital beds. Figures 1, 2 and 3 show respectively the overload, lateral stability and fatigue tests.
Figure 2. Lateral stability test.
Once the risk analyses were carried out and following an analysis of the requirements of the materials and the results of the evaluations, the entire process was correctly identified and documented in the technical dossier with which the company can properly certify its products.
Figure 3. Fatigue test.
The joint work between the Instituto de Biomecánica (IBV) and ECOPOSTURAL, tailored to the needs of the company, has ensured its compliance with the requirements of the new European regulation on medical devices. In addition, it has made it possible to correct and improve a number of specific elements based on the results of the tests. In short, the company now has a better product on the market and enhanced possibilities of commercial success. As an expert in the development and evaluation of medical devices, the IBV advises companies on how they can improve their products. In this way, rather than being a mere evaluator of a company’s products, the IBV is in fact a center that collaborates with companies in the sector in the improvement of their products.
The project undertaken by the IBV with ECOPOSTURAL highlights the need there is for technology centers in the Valencian Community that can support companies in the field of HEALTHCARE in the new and complex process of design, evaluation and certification of medical devices under the new regulation (MDR).