How Have the EU MDR and IVDR Changed Clinical Investigations?

The European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) have brought about significant changes to clinical investigations of the devices that they regulate. 

In the context of the European Union Medical Device Regulation (EU MDR, Regulation (EU) 2017/745), “clinical investigations” refer to systematic studies conducted on human subjects to assess the safety or performance of a medical device. These are different from “clinical trials,” which are more narrowly focused on evaluating the safety and efficacy of medical interventions such as pharmaceuticals.

Clinical investigations are a critical component of the regulatory framework for medical devices in the EU, designed to ensure that devices are thoroughly evaluated for safety and effectiveness before they reach the market or are used in clinical settings.

The EU’s MDR regulations have been evolving since they were first issued, but rules for clinical investigations have remained consistent. However, these regulations have also come with some regulatory upgrades that have made it more challenging (in a good way) to get devices certified.

Clinical Investigations Under the EU Regulations

The European Union’s MDR and IVDR introduced significant changes to how clinical investigations are conducted, scrutinized, and documented. Because the burden for certification is higher now, let’s take a closer look at these pivotal requirements and their implications for manufacturers.

Stricter Requirements for Clinical Evidence

The EU MDR and IVDR require a higher burden of proof for clinical data that verifies the safety and performance of medical devices. This means that manufacturers must now present more robust, comprehensive, and scientifically valid evidence to demonstrate their device’s efficacy and safety. 

Enhanced Oversight and Scrutiny

Under the MDR and IVDR, regulatory authorities and Notified Bodies have increased scrutiny over clinical investigations. The submission process for clinical investigation applications has become more stringent and include detailed requirements that demand meticulous attention from manufacturers. This strict oversight ensures that clinical investigations are designed and conducted according to the highest standards, emphasizing patient safety and the integrity of the data collected.

Expanded Scope of Clinical Investigations

The MDR and IVDR have broadened the definition of a clinical investigation. Besides traditional pre-market clinical trials, the scope now includes Post-Market Clinical Follow-up (PMCF) studies and other forms of post-market surveillance. This expansion acknowledges the importance of continuous data collection and analysis over a device’s lifespan, ensuring ongoing assessment of its safety and performance even after it has entered the market.

Greater Transparency and Public Access to Information

A defining characteristic of the medical device regulations is the requirement for transparency regarding clinical investigations. Manufacturers are obliged to make information about clinical investigations, including safety and clinical performance summaries, accessible to the public through the European Database on Medical Devices (EUDAMED). This openness is intended to encourage trust in the medical device industry while also empowering patients and healthcare professionals by providing them with crucial information about medical devices.

More Detailed Documentation and Reporting

The regulations mandate that manufacturers maintain extensive documentation throughout the clinical investigation process. This documentation should cover every facet of the study, from the clinical investigation plan and informed consent documents to detailed reports on the conduct and outcomes of the studies. This requirement ensures traceability, accountability, and the ability to thoroughly review and assess the clinical evidence supporting a device.

Increased Responsibility for Manufacturers

Finally, MDR and IVDR place a greater responsibility on manufacturers to ensure the safety of trial participants, the scientific validity of study designs, and the ethical conduct of clinical investigations. Manufacturers must now take a proactive role in safeguarding the welfare of participants and ensuring that their studies meet the stringent criteria set forth by the regulations.

Exceptions to Clinical Investigations

Under the EU MDR and IVDR, certain scenarios exempt medical devices from the requirement for clinical investigations:

1. Equivalent Devices: If a manufacturer can demonstrate that their device is equivalent to an existing device already on the market, and they have access to the data needed to support safety and performance claims, a new clinical investigation may not be required.
2. Well-Established Technologies: Devices utilizing well-established technologies with a documented history of safety and effectiveness might bypass new clinical investigations if comprehensive justification is provided.
3. Minor Changes: Modifications to an already approved device that do not significantly affect its safety and performance may not necessitate further clinical investigation. 

However, these exceptions are contingent on thorough justification and documentation to ensure continued compliance with safety and performance standards.

Looking Ahead

The EU MDR and IVDR have significantly reinforced the importance of clinical investigations, setting new benchmarks for clinical evidence, oversight, and transparency. These regulations demand more from manufacturers, necessitating thorough validation of safety and performance claims through detailed clinical investigations. This shift towards rigorous evaluation processes underscores a commitment to safeguarding patient safety and ensuring device efficacy before market entry.

For healthcare professionals and patients, the requirements promise greater access to reliable device information, enabling informed decision-making and enhancing quality care. As the medical device industry adapts to these regulations, the ultimate goal remains to enhance public health protections within the EU and create a healthcare environment marked by trust, safety, and innovation.

Navigating Regulatory Requirements with Argos

At Argos Multilingual, we are an experienced partner for medical device companies navigating the intricacies of the EU’s MDR and IVDR. Our commitment to accuracy and safety ensures that your medical devices transcend language barriers, reaching patients and practitioners worldwide.

Do you have questions about languages, translation, and compliance? Contact us to learn how Argos Multilingual can support your MDR or IVDR efforts.