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 ISQ Administration.
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.
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, 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.