9 Articles
The AEMPS updates its Services Charter for 2026-2029. Manufacturers, importers and distributors of medical devices can d...
Delegated Regulation (EU) 2026/1359 updates which class IIb implants are exempt from individual technical review. Manufa...
Delegated Regulation (EU) 2026/1451 updates the list of class III implants and devices exempt from prior clinical invest...
The EU corrects harmonized standards for medical devices and medical equipment. Manufacturers, importers and distributor...
The EU updates harmonized standards for 9 categories of medical devices. Manufacturers and importers must review their c...
The EU updates the EN ISO 15223 standard on symbols in medical device labeling. Manufacturers, importers and distributor...
The correction of Regulation (EU) 2026/977 affects notified bodies and manufacturers of medical devices. Review the corr...
Regulation 2026/977 harmonizes quality requirements for notified bodies in the EU. Medical device and in vitro diagnosti...
The AEMPS announces a specific contest to fill positions in 2026. It affects civil servants of the AGE seeking promotion...