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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.

We are pleased to announce our participation as an exhibitor at MedTec Japan 2025, one of Asia’s leading trade shows for medical device design and manufacturing. The event will take place in Tokyo from April 9–11, 2025.

Swissmedic has released findings from a recent focused action, underscoring the critical importance of robust Post-Market Surveillance (PMS) for all medical devices.

The European Commission has released the second revision of the MDCG 2023-3 guidance document in January 2025. This update includes important clarifications in line with Regulation (EU) 2024/1860

The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2.

The European Commission has launched a public consultation as part of its targeted evaluation of the EU rules on medical devices and in-vitro diagnostics.