📢 The Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices, AEMPS) announces the update of the previous Instruction PS1/2022 to include requirements established in Real Decreto 192/2023 (Royal Decree) of 21 March, regulating medical devices.
The new requirements apply to:
✅ Series manufacturers✅ Manufacturers of complete products for third parties✅ Importers, both legal and physical.✅ Producers of systems and procedure packs (Article 22 of Regulation (EU) 2017/745)✅ Third-party sterilisers✅ Reprocessing manufacturersFor the following products:
✔️Medical devices and their accessories✔️In vitro diagnostic medical devices and their accessories✔️Products listed in Annex XVI of Regulation (EU) 2017/745 of 5 April 2017✔️Apparatus and instruments used for permanent or semi-permanent make-up or skin tattooing by invasive techniques.
You can obtain it here 👉 https://lnkd.in/dsFcqAMV📄It contains instructions for processing operating licences for medical device facilities, as well as their modifications and revalidations.