Latest Publications

Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR.   This article seeks to [...]

Looking For A World Class CER Writer for your EU MDR Submission? EU MDR has certainly made things more difficult for manufacturers seeking the CE mark, especially in regard to Clinical Evaluation. If you [...]

With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance [...]

What the Medicines and Healthcare Products Regulatory Agency Does? MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for [...]

Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). [...]

The MDSW is defined as a Medical Device regardless of its location of use. Software driving or influencing a medical device's use can qualify as a device. Software intentionally to process, analyze, create or [...]

Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article [...]

What will the new EU regulations mean for in vitro diagnostics? In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. [...]

The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs.   It may include - The certification [...]

The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means [...]

The EU MDR Delay – What It Means For Your Medical Devices With the global COVID-19 pandemic disrupting industries, medical device stakeholders have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance [...]

EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or [...]