PRODUCTS WITHOUT MEDICAL PURPOSE. ANNEX XVI PRODUCTS
https://www.devicesistemas.com/wp-content/uploads/2023/06/depilacion-laser.jpg On June 22, 2023, the Implementing Regulation 2022/2346 of December 1, 2022 comes into effect, establishing the Common Specifications for Products Without Medical Purpose under Regulation (EU) 745/2017. This means that from that date, products without medical purpose that are part of this Annex XVI of the MDR must comply with the Regulation’s requirements […]
THIRD-PARTY PRODUCT MANUFACTURERS: NEW PRIOR OPERATING LICENSE
Manufacturers who perform the complete manufacturing of medical products for third parties must obtain the operating license granted by AEMPS.
NEWS. THE NEW ROYAL DECREE ON MEDICAL DEVICES RD192/2023
Updates in Spanish legislation on medical devices. Royal Decree 192/2023, dated March 21, introduces new requirements for manufacturers, importers, and reprocessors of single-use products, among others.
Requirements for “In house” Medical Products.
https://www.devicesistemas.com/wp-content/uploads/2022/12/articulo-in-house-device-sistemas.jpg MDR and IVDR Requirements for Products Manufactured in house It is common practice for healthcare centers in general and hospitals in particular to manufacture medical products, as clinicians often face difficulties in finding medical products that meet specific needs for a patient or patients, for a particular ailment or treatment. This practice is colloquially […]
Surveillance Measures for the Import of Electrical Equipment.
https://www.devicesistemas.com/wp-content/uploads/2022/05/Importador-de-AEE-device-sistemas.jpg Surveillance Measures for the Import of Electrical Equipment (EEE), Accumulators, Batteries, and Cells The concern about waste generation is increasingly significant both among ordinary citizens and governments and institutions. Today, we have regulations that govern the use of certain hazardous substances; the European Union has the directive (EU) 2011/65/EU, also known as RoHS, and […]
MDR and Lasers for Tattoo Removal
https://www.devicesistemas.com/wp-content/uploads/2022/05/mdr-eliminacion-tajuajes-normativa-device-sistemas.jpg MDR and Lasers for Tattoo Removal. Regulation (EU) 745/2017 Tattoos are increasingly common among people of all ages. They come in colors, black and white, large, small, etc., all made with ink and very specific instruments to achieve the best result in the safest possible way. To date, both the manufacture of inks and […]