Is My Software a CDx or Not?
https://www.devicesistemas.com/wp-content/uploads/2024/10/IVDSW.png Software as an In Vitro Diagnostic Medical Device First, before determining whether our software is a CDx or not, we must adequately justify that our software is an In Vitro Diagnostic Medical Device. (according to IVDR). An In Vitro Medical Device Software (IVDSW) is one that meets the definition of an In Vitro Diagnostic […]
Performance Evaluation and Clinical Trials in IVD Products, According to Regulation (EU) 746/2017 (IVDR)
https://www.devicesistemas.com/wp-content/uploads/2021/09/hans-reniers-lQGJCMY5qcM-unsplash.jpg The Performance Evaluation and clinical trials in IVD products are key to demonstrating compliance with the requirements of Annex I of the IVDR. This confirmation of product compliance with the general safety and performance requirements (Annex I) of the IVDR must be based on data regarding the scientific validity and analytical and clinical performance […]
Medical Device Software MDSW. CE Marking Marketing Strategies
Medical Device Software MDSW are medical products that must have CE Marking to be marketed in the European Union. MDSWs that work together with a medical product or component of a medical product can use different marketing strategies to be sold in the European Union.
Is my software or application a medical device?
https://www.devicesistemas.com/wp-content/uploads/2023/11/app-sofware_producto_sanitario.jpg Determining which health “apps” and/or software are considered medical devices varies according to the laws of each country. Is my health-oriented software or application a medical device? There is no doubt that mobile phones and tablets with all their applications have represented technological advancement, and of course, these advancements have also affected the healthcare […]
E-commerce in the distribution and sale of healthcare products, tattoo and aesthetic instruments from Annex XVI, is it possible?
https://www.devicesistemas.com/wp-content/uploads/2023/07/e-commerce.jpg On March 21, the RD 192/2023 on healthcare products was published. This Royal Decree has brought a series of substantial changes especially for manufacturers and importers of healthcare products, products from Annex XVI, instruments for tattoos and semi-permanent and permanent makeup, and reprocessors of single-use products. This time we will focus on a modification […]
European Community Requirements for CE Product Marking
https://www.devicesistemas.com/wp-content/uploads/2022/03/marcado-producto-ce-requisito.jpg European Community Requirements for CE Product Marking What is the CE marking? All the products we consume every day in the European Union must meet a series of requirements that ensure their quality and safety. The CE marking guarantees that the item has passed the manufacturing, health, design, and environmental protection controls set by […]
Person Responsible for Regulatory Compliance
https://www.devicesistemas.com/wp-content/uploads/2022/02/persona-responsable-cumplimiento-normativo-device-sistemas.jpg Person Responsible for Regulatory Compliance The MDR and the Person Responsible for Regulatory Compliance On May 26, 2021, Regulation (EU) 745/2017 or MDR came into effect. This European regulation brought numerous changes regarding the legal requirements to be met in the marketing of medical devices (and related products) in Europe, or in other […]
Difference Between CE Marking and the China Export Logo
https://www.devicesistemas.com/wp-content/uploads/2022/02/diferencia-marcado-ce-y-logo-chino-device-sistemas.jpg Difference Between CE Marking and the China Export Logo When buying a product, it is especially important to consider its quality, but not all certificates are the same. Hence the need to know what CE marking is and what the China Export logo is to know which items are of higher quality. What […]
Obligations of Medical Device Importers
The entry into force of MDR and IVDR brings new obligations and responsibilities for medical device importers.
MDR and IVDR Changes in ISO 13485 QMS
https://www.devicesistemas.com/wp-content/uploads/2021/10/MDR-e-IVDR-Cambios-en-ISO.jpg MDR and IVDR CHANGES IN ISO 13485 QMS Changes that MDR and IVDR are causing in ISO 13485 QMS All of us working in the Medical Device field are aware that the new regulations MDR and IVDR are bringing a series of significant changes to the various economic operators involved: manufacturers of medical devices, […]