Expert Regulatory & Quality Support for MedTech Innovators

The EU Medical Device Regulation 2017/745 (MDR) represents one of the most significant regulatory shifts the MedTech industry has ever faced. Introduced to strengthen patient safety, clinical evidence, and post-market oversight, the MDR has raised the bar for bringing medical devices to the European market and for keeping them there. For startups, scale-ups, and SMEs, the regulation can feel complex, resource-intensive, and difficult to interpret, particularly when guidance continues to evolve.

MD Compliance supports medical device companies in implementing risk management processes that are practical, defensible, and fully aligned with regulatory expectations. We help you move beyond checkbox compliance with ISO 14971, ensuring risk management actively supports safe device design, robust technical documentation, and clear, credible claims while remaining proportionate to your organisation and product risk profile.

Following the UK’s exit from the European Union, the regulatory framework for placing medical devices on the Great Britain market has undergone significant change. The UK Conformity Assessed (UKCA) marking is now the primary route for demonstrating compliance with UK medical device regulations and enabling legal market access in England, Scotland, and Wales.

The EU In Vitro Diagnostic Medical Devices Regulation 2017/746. represents a fundamental shift in the regulatory oversight of in vitro diagnostic medical devices. Introduced to strengthen patient safety, clinical evidence, and performance transparency, the IVDR has significantly increased regulatory expectations compared to the former IVDD. One of the most impactful changes is the reclassification of the majority of IVDs, resulting in far greater involvement of Notified Bodies and a substantial increase in the depth and scrutiny of conformity assessments.

Post-market surveillance (PMS) has taken on a far more prominent and structured role under the EU Medical Device Regulation 2017/745 (MDR). Manufacturers are now required to proactively and systematically collect, analyse, and act on data relating to device performance and safety throughout the entire product lifecycle. PMS is no longer a passive, complaint-driven activity – it is a continuous regulatory obligation and a key pillar of MDR compliance.

Clinical evaluation is a cornerstone of medical device compliance under the EU Medical Device Regulation 2017/745 (MDR). The MDR has significantly raised the bar for clinical evidence, requiring manufacturers to demonstrate safety, performance, and clinical benefit through a systematic and continuously updated process. For many devices, particularly those transitioning from the MDD, this has resulted in increased scrutiny of clinical data quality, relevance, and traceability.

Navigating the US Food and Drug Administration (FDA) regulatory landscape is a critical step for any medical device company targeting the world’s largest MedTech market. While the FDA framework is well established, it is also highly structured, detail-driven, and unforgiving of missteps. For startups and SMEs, understanding how to position a device, select the right regulatory pathway, and engage effectively with the Agency can make the difference between a smooth clearance process and significant delays.