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March 28, 2025

MedNet EC-REP at CMEF Shanghai 2025

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.

March 28, 2025

New Revision of MDCG 2020-16 Guidance on IVD Classification: Key Updates in Version 4

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).

March 26, 2025

UK Updates Post-Market Surveillance Requirements for Medical Devices

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

March 25, 2025

ISO 15223-1 Amendment: EC-REP Symbol Changes to EU-REP

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.

March 6, 2025

MedNet EC-REP at MedTec Japan 2025 – Meet Us at Booth 3303

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.

March 3, 2025

Swissmedic Highlights Post-Market Surveillance Obligations for Legacy Devices

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

February 11, 2025

EU Publishes Second Revision of MDCG 2023-3: Key Updates for Manufacturers

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

February 10, 2025

EU Commission Updates Guidance on SARS-CoV-2 Test Classification

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

January 15, 2025

EU Initiative on Medical Devices and In-Vitro Diagnostics: A Targeted Evaluation

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.

January 14, 2025

Meet Us at Arab Health 2025!

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.

September 6, 2024

MedNet EC-REP GmbH to Exhibit at MEDICA 2024 in Düsseldorf

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.

September 2, 2024

MedNet EC-REP GmbH Successfully Renews ISO 13485:2016 Certification

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

July 6, 2024

Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers

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

May 7, 2024

Deadline Alert: Submission Requirements for MDR Conformity Assessment

Important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607.