News & Infos

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.

We are thrilled to announce that we will be attending Arab Health 2025, taking place from Monday, January 27, 2025, to Thursday, January 30, 2025, in Dubai.

We are excited to announce its participation at MEDICA 2024, the world’s leading trade fair for the medical industry, taking place from November 11th to 14th in Düsseldorf, Germany.

We are pleased to announce that MedNet EC-REP GmbH has successfully renewed its ISO 13485:2016 certification.

The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the MDR