The European Union (EU) has implemented two key regulations — the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — designed to enhance both patient safety and transparency.
The new regulations apply to companies manufacturing or distributing medical devices within the EU. While the final compliance deadlines for MDR (2026-2027) and IVDR (2025-2027) have been extended, many critical procedural requirements are already in effect.

Organizations must have made significant progress by now and be looking to transition into full compliance, as meeting the new standards is a significant undertaking. These regulations mandate that all medical devices undergo stringent clinical testing to meet rigorous safety standards, so having started early in preparation would have been essential for a smooth transition.

Key changes to MDR and IVDR
One of the biggest shifts in MDR is the introduction of new risk categories for medical devices. This means some products might require reclassification, making it necessary for companies to reassess their entire product line. The regulation also brings new clinical evaluation requirements, risk assessment and postmarket surveillance (PMS) requirements. These changes demand that companies closely monitor the performance of their products even after they have been approved and brought to market in a way that goes beyond the requirements of the “old” directives.

MDR also introduces a new Unique Device Identification (UDI) system. This system assigns each device a unique code for better tracking and transparency throughout the product’s lifecycle. Alongside this, MDR creates a new central database called EUDAMED. This platform is designed to store and share data about medical devices, giving regulators and the public more information about device safety and performance.

For in-vitro diagnostics, the IVDR follows a similar path. It introduces a new risk classification system that groups devices into four categories, from Class A, which poses the least risk, to Class D, which poses the highest risk. This classification system allows regulators to focus on devices that pose the greatest risks to patients and public health. Like MDR, IVDR requires companies to enhance PMS and conduct performance evaluations to ensure ongoing safety.

Both MDR and IVDR increase the role of notified bodies, independent organizations that assess whether devices meet the required European regulations and standards. These organizations have more oversight, and their approval process has become more stringent. This increased scrutiny is intended to improve the quality of devices on the market and ensure patient safety is the top priority.

MDR and IVDR’s impact on the industry
The new MDR and IVDR regulations increase oversight, stricter data collection and reporting requirements, reshaping how companies develop and market medical devices.

MDR’s new risk categories require some products to be reclassified, forcing manufacturers to reassess their portfolios and adjust to higher regulatory demands. The role of notified bodies has expanded, with increased oversight ensuring higher safety and performance standards. MDR also enhances transparency, giving patients better access to device information.

In addition, MDR introduces stricter quality management system requirements, mandating better quality processes throughout the product lifecycle. The UDI system is a key component that improves traceability and supports PMS. MDR also requires more comprehensive clinical data collection, postmarket follow-up studies and strengthened surveillance before approval. EUDAMED’s central database (which is yet to be in full force) facilitates transparency by housing data on devices, clinical trials and performance.

Under IVDR, PMS requirements have been strengthened, and the UDI system further supports traceability and patient safety. IVDR also raises demand for performance evaluations and clinical studies, ensuring devices are thoroughly tested before market approval. Like MDR, IVDR relies on EUDAMED to enhance transparency and regulatory oversight.

Overall, the regulations push for higher safety standards, greater transparency and more robust PMS, representing both challenges and opportunities for the industry to improve device quality and patient care.

Challenges to compliance
While the extended deadlines for MDR (2026-2027) and IVDR (2025-2027) offer companies more time to comply with some elements, they also present challenges. There are a limited (but increasing) number of notified bodies, and companies may experience difficulty finding one with the expertise to assess their specific products. This creates a bottleneck that could delay the certification process for many devices.

In addition, the implementation of EUDAMED, while delayed, still looms over the industry. This comprehensive database will eventually require companies to submit large amounts of data, including clinical and performance evaluations. Companies that are unprepared for these requirements could find themselves struggling to meet the final deadlines, potentially resulting in the discontinuation of certain products.

The delays in the full rollout of EUDAMED have given companies some breathing room. However, this time should be used wisely. Medical device firms must begin preparing for the new system by collecting the necessary data and working with notified bodies to ensure smooth compliance. Waiting until the last minute could lead to costly delays and missed market opportunities.

A significant shift
The new MDR and IVDR regulations represent a significant shift in the way medical devices are regulated in the EU. While the final compliance deadlines may seem to be a goalpost that keeps moving, companies must act now to meet the new requirements and complete their transition activities. The changes brought by these regulations, including new risk classifications, enhanced PMS and the introduction of EUDAMED, will ultimately improve patient safety and transparency. Companies that complete their compliance efforts before the deadlines will avoid last-minute challenges and position themselves for success.

Mike King is senior director of product and strategy (quality, regulatory, safety and detect) for Digital Products & Solutions at IQVIA. He has close to 20 years of knowledge and experience leading localized and global teams in regulatory affairs and quality assurance and has worked within the medical and surgical, orthopedic, in vitro diagnostic, diagnostic imaging, dental and urology sectors.
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.