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The European Union Medical Device Regulation (EU MDR) is the regulatory framework governing medical devices placed on the European market. Introduced to enhance patient safety, improve transparency, and strengthen clinical evidence requirements, the MDR represents the most significant change to European medical device legislation in decades.

For manufacturers, importers, distributors, authorised representatives and regulatory professionals, understanding the MDR is essential for achieving and maintaining market access in Europe. This guide provides a comprehensive overview of the regulation, its requirements and the practical steps organisations must take to achieve compliance.

The In Vitro Diagnostic Regulation (IVDR) has transformed the regulatory landscape for diagnostic devices in Europe. Whether you are developing a new in vitro diagnostic medical device, transitioning a legacy product from the IVDD, or preparing for CE marking, understanding the requirements of Regulation (EU) 2017/746 is essential. This comprehensive guide explains IVDR classification, manufacturer obligations, performance evaluation, technical documentation, conformity assessment, post-market surveillance, and the practical steps needed to achieve and maintain compliance within the European market.

Bringing a medical device to the European market requires careful planning and compliance with the EU Medical Device Regulation (EU MDR 2017/745). This guide outlines the key stages of the regulatory journey, from device determination and classification through Quality Management Systems, Technical Documentation, CE marking and ongoing Post-Market Surveillance.

Learn how to plan, conduct and document ISO 27001 internal audits in line with Clause 9.2, including audit programmes, auditor impartiality, reporting findings, corrective actions and continual improvement.

Notified Bodies play an important role in medical device certification under the EU MDR and IVDR. This article explains what a Notified Body does during conformity assessment, what it reviews before certification, its role in CE marking, and how its responsibilities continue after certification.

Medical device manufacturers aiming to market their products in the European Union must navigate a complex regulatory landscape. At the heart of this framework is the EU Medical Device Regulation (MDR) 2017/745, which replaced the Medical Device Directive (MDD). One of the most critical components of this regulation is the General Safety and Performance Requirements (GSPRs), outlined in Annex I of the MDR.

Discover how 5G connectivity is transforming connected medical devices, remote patient monitoring and digital healthcare. Learn how manufacturers can harness faster, more reliable communications while meeting MDR, IVDR, cybersecurity and regulatory requirements.

3D printing, also known as additive manufacturing, is transforming the medical device industry. From custom prosthetics to complex surgical instruments, this technology is revolutionizing how medical devices are designed, manufactured, and delivered to patients. As the healthcare sector continues to evolve, 3D printing plays an essential role in innovation, personalization, and cost efficiency.

The Internet of Medical Things (IoMT) is transforming healthcare by connecting medical devices, patients and healthcare professionals through intelligent digital technologies. Discover how IoMT supports remote patient monitoring, connected hospitals, smarter diagnostics and the future of digital healthcare.

Understand medical device packaging validation, including ISO 11607 requirements, sterile barrier systems, seal integrity, ageing, distribution testing and packaging process validation.