The Medical Device Coordination Group (MDCG) is a regulatory body established by the European Union to help ensure that the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices are consistently and effectively applied across all EU member states.

Here’s a closer look at the MDCG’s primary functions:

–          Guideline Development and Revisions: By establishing clear and standardised guidance, the MDCG promotes a consistent approach to the interpretation and uniform application of MDR and IVDR requirements, helping build a cohesive and harmonised regulatory environment for medical devices across EU countries. Regular updates to these guidelines aim to reduce ambiguities and reflect recent amendments, keeping industry stakeholders informed of the latest requirements.

–          Addressing New Technologies: Recognising the regulatory challenges posed by rapid innovation in medical technology, the MDCG develops specialised guidelines to clarify product classification boundaries. It also offers expert recommendations on new technologies, such as medical software and AI-based devices, to support manufacturers in bringing innovative products to market in compliance with regulations.

–          Simplification and Streamlining: The MDCG also develops standard templates, forms, and tools to make regulatory documentation clearer and to facilitate smoother assessment processes.

–          Promoting Transparency: The MDCG fosters transparency by sharing regulatory information and data on publicly accessible platforms. This includes publishing guidance documents, meeting minutes, and updates on the European Commission’s health and medical devices website. The MDCG also coordinates responses to public consultations and stakeholder feedback, integrating this input into regulatory practices.

For the latest updates, news, and resources—including the most recent guidelines—visit the European Commission’s medical devices sector platform at https://health.ec.europa.eu/medical-devices-sector/latest-updates_en.

The MDCG’s guidance serves as a reference for best practices. While these documents are valuable for understanding regulatory expectations and supporting the uniform application of EU regulations, it is essential to note that they are not legally binding.