COVID-19: ISQ makes compliance assessment of medical devices and personal protective equipment

ISQ is providing services to support the fight against COVID-19. These ensure that Medical Devices (DM) and Personal Protective Equipment (PPE) comply with the requirements of European Union (EU) regulations. "ISQ thus shares its knowledge with national manufacturers and competent supervisory bodies. In the current pandemic scenario, where citizens' health and safety is at stake, it is crucial to ensure that the necessary MDand PPE are effective in combating Corona SARS Cov-2," said Besma Kraiem, ISQ Administrator. At a time when it is essential to ensure the protection of professionals and the general population, ISQ supports the Class I and PPE DM Conformity Assessment for use in a clinical or pharmaceutical context. "In the context of Class I DM, the ISQ supports the manufacturer in the implementation of the Conformity Assessment procedure and its assessment itself, to be submitted to the Supervisory Authority (INFARMED), with regard to the verification of medical devices which must ensure an adequate level of health and safety, in accordance with the essential requirements set out in Regulation (EU) 2017/745, and the requirements of Directive 93/42/EEC for the purpose of making these products available on the market to healthcare professionals," adds José Medina, Director of ISQ Laboratories. The ISQ is available to carry out this support by preparing and evaluating the on-site technical documentation, which is considered sufficient for Class I DM. If this documentation does not exist, the ISQ advises the manufacturer in its preparation, representing it in this matter. "In relation to PPE for use in a clinical and pharmaceutical context, ISQ supports the manufacturer as a third-party Conformity Assessment body," says José Medina. This support covers the assessment and contact with the supervisory authority (ASAE) for the purpose of placing PPE on the Union market for a limited period or, while the evaluation procedure is being drawn up, in accordance with the essential requirements set out in Regulation (EU) 2016/425. In the context of PPE for use in a clinical and pharmaceutical context, the support also covers the carrying out of the report evaluating safety and performance requirements and the verification of the issuance of the declaration of commitment of conformity of products, as well as the monitoring of the distribution and sales channels of ppe to health professionals.  

Conformity Assessment is the verification process carried out by the manufacturer through which the specific requirements applicable to a given product are demonstrated. Even if a manufacturer subcontracts design or production, it remains responsible for conformity assessment. The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market comply with the requirements of the relevant legislation.

ABOUT ISQ

ISQ is a private, independent entity that delivers value through integrated and innovative engineering, inspection, testing, testing and training services solutions.

Present in 14 countries and with 7 offices in Portugal, ISQ supports its customers in reducing risk, improving operational performance and increasing competitiveness. multidisciplinary teams that help clients to align their business objectives with applicable regulations and standards and in meeting their goals in the areas of quality, safety, asset management and environmental and social responsibility.

Industry, Technology and Innovation are the premises that guide the work developed by ISQ, which already has more than 500 international Innovation projects and more than 17,000 professional training courses.

ISQ supports industry development and innovation on a global scale, with service solutions for the Oil & Gas, Energy, Aeronautics and Aerospace, Process Industry, Health, Mobility and Smart Cities, Transport and Infrastructure and Agribusiness sectors.

ISQ PRESS AND COMMUNICATION OFFICE

Carla Guedes      | cmguedes@isq.pt          | +351 919 211 647