Meet us at MedTec Japan 2025! 📅 April 9–11 | Booth 3303 | Schedule a meeting

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, demonstrating our continued commitment to maintaining the highest standards in quality management for medical devices.

The ISO 13485:2016 certification is an internationally recognized standard that sets stringent requirements for quality management systems. This renewal confirms that MedNet EC-REP GmbH remains as a reliable and trusted European Authorized Representative for medical device manufacturers around the world.

At MedNet EC-REP, we pride ourselves on our meticulous approach to regulatory compliance and our unwavering focus on quality assurance. This certification not only validates the effectiveness of our internal processes but also underscores our dedication to helping our clients navigate the complex regulatory environment of the European market.

The renewal of our ISO 13485:2016 certification also highlights the hard work and commitment of our entire team. Their expertise, attention to detail, and continuous improvement mindset enable us to consistently provide the highest level of service to our clients. We remain committed to staying ahead of industry developments and regulatory changes to ensure that our clients are always compliant and well-prepared for market success.

By choosing MedNet EC-REP GmbH as your European Authorized Representative, you can trust that your business is supported by a team that prioritizes quality, compliance, and regulatory excellence. We look forward to continuing our partnership with medical device manufacturers globally, ensuring their products meet all necessary requirements for European market access.

For more information on our services or to learn how we can assist your business, feel free to contact us today.

Latest news

MedNet EC-REP at CMEF Shanghai 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.

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

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).

UK Updates Post-Market Surveillance Requirements for Medical Devices

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.

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

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.

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

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.

Swissmedic Highlights Post-Market Surveillance Obligations for Legacy Devices

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.

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

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

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

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.