Medical Device Post-launch

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.

companies operating in regulated sectors such as medical devices, healthcare, and life sciences, protecting sensitive information—whether patient data, design documents, or clinical trial results—is not only critical for business continuity but also required under stringent regulatory obligations. This is where ISO/IEC 27001, the international standard for Information Security Management Systems (ISMS), comes into play.

Ensuring safety and efficacy is paramount for medical devices. Manufacturers aiming to market their products within the European Union must navigate a complex regulatory landscape. One of the most critical aspects of this process is obtaining CE marking—a declaration that a product complies with all relevant EU legislation. Central to this pathway is the involvement of Notified Bodies (NBs).

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.

In the medical device industry, packaging serves a crucial role. It not only ensures the integrity and sterility of the device but also safeguards it from environmental factors during transportation and storage. Packaging validation is, therefore, a vital process that ensures medical devices arrive in the hands of healthcare providers and patients in the safest and most effective condition.