# Regulation (EU) 2017/745
Who / What
**Regulation (EU) 2017/745** is a political regulation of the European Union that governs the clinical investigation and market placement of medical devices intended for human use. It replaces two previous directives, Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD), to modernize regulatory standards in the EU.
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Background & History
Regulation (EU) 2017/745 was developed as part of the European Union’s broader efforts to harmonize medical device regulations across member states. The predecessor directives, MDD and AIMDD, were established in the early 1990s but faced challenges such as inconsistent enforcement, outdated requirements, and gaps in post-market oversight. Following extensive public consultation and technical revisions, the new regulation was adopted to address these issues, ensuring stricter safety, performance, and transparency standards for medical devices.
The regulation was published on **5 April 2017** and came into force on **25 May 2017**, with full implementation beginning on **26 May 2021**. This phased transition allowed manufacturers to gradually adapt their compliance processes while maintaining continuity in the market.
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Why Notable
This regulation is notable for its comprehensive approach to modernizing medical device safety and quality standards within the EU. By replacing outdated directives, it introduces stricter requirements for clinical trials, risk management, post-market surveillance, and manufacturer responsibilities. The regulation also enhances transparency by mandating better reporting of adverse events and facilitating cross-border cooperation among member states.
Its impact extends beyond the EU, influencing global medical device regulations through its influence on international bodies like the International Medical Device Regulators Forum (IMDRF). Achievements include improved patient safety, reduced market risks for manufacturers, and greater alignment with evolving scientific and technological advancements in healthcare.
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In the News
As of recent years, Regulation (EU) 2017/745 remains a critical framework shaping discussions on medical device innovation, cybersecurity risks, and post-COVID-19 recovery in healthcare. The EU has continued to refine its implementation through guidance documents and enforcement actions, particularly focusing on addressing emerging challenges such as digital health technologies and the integration of AI-driven diagnostics.
Recent developments include increased scrutiny over non-compliant devices, accelerated reviews for critical medical products during pandemics, and efforts to streamline certification processes while maintaining high safety standards. The regulation’s relevance persists as a cornerstone of EU policy in ensuring that medical devices meet rigorous quality and safety benchmarks.
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Key Facts
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