Noticias e Información

The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU).

Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).

The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).

In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.

The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms."

The European Commission has released a new version of the Manufacturer Incident Report (MIR) form which will become mandatory for all medical device manufacturers from November 2025.

The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).

The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the MDR.

We are pleased to announce that we will be exhibiting at the China International Medical Equipment Fair (CMEF) in Shanghai from April 8 to April 11, 2025.

The Medical Device Coordination Group (MDCG) has released Revision 4 of the "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" (MDCG 2020-16).

The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain.

The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC-REP" to "EU-REP" for the European Authorized Representative symbol.