Clinical data and the MDR

All medical devices placed on the EU market must be supported with clinical data. “For each medical device you need clinical data, and that data needs to come from either market experience or clinical studies,” explains Erwin.

For brand-new devices, that market data simply doesn’t exist. Manufacturers must therefore rely on investigations to demonstrate compliance with the EU MDR’s General Safety and Performance Requirements (GSPRs). 

For low-risk devices, literature reviews, simulated use, or performance testing may suffice. But for Class III devices and implantable Class IIb devices, clinical investigations involving human subjects are mandatory.

Two types of clinical investigation

The MDR defines two categories of clinical investigation:

1. Article 62 investigations – These apply to new product registrations. They’re required to generate evidence for CE marking of devices that do not have sufficient existing data.
2. Article 82 investigations – These apply to CE-marked devices already on the market. They are often used for comparison studies, subgroup analysis, or to confirm performance in new patient populations.

“Article 62 is about proving a new use case for a device, whereas Article 82 is about making comparisons with similar products,” explains Erwin. “For Article 62, you need full approval from competent authorities and ethics committees. Article 82 is less restrictive, since the device is already CE-marked and used as intended.”

Clinical trials: organization and approval

Documentation such as the Clinical Investigation Plan (CIP), patient information materials, and translated protocols must be meticulously prepared. Unlike pharmaceuticals, where a single EU-wide approval may apply, clinical investigations for medical devices require separate submissions in every country where the study is conducted. 

Each national competent authority and every local ethics committee must approve the protocol. “This makes organization highly complex,” notes Erwin. “You might have one coordinating member state, but at the end, each country and even each hospital ethics committee must approve the study and its documentation.” 

Reasons for multi-country testing

While managing approvals in multiple countries is demanding, there are strategic reasons to pursue multi-country studies. One reason is simple: numbers. Large-scale or special population investigations may require a statistically relevant number of patients, which no single care institute or country can provide.

But there are also scientific and commercial advantages. “You don’t want the expertise to be specific to one country or one institute,” explains Erwin. “Surgical procedures may vary across Europe, and incorporating different clinical experiences strengthens the data.” Diverse trial sites also support risk evaluation by accounting for regional differences in practices. Also specialists, already having experience with your investigational devices, may be good advocates for your device later on in the commercial adoption phase of the CE-device.  

Clinical investigations and post-market follow-up

Even when a clinical investigation concludes, the process doesn’t end there. Under the MDR, manufacturers must continue with Post-Market Clinical Follow-up (PMCF) to confirm that clinical evidence holds true in real-world usage.

“There are always two aspects that follow a clinical investigation,” says Erwin. “Market experience, which must confirm the clinical evidence, and possible improvements, which scientists may already have identified. These feed into PMCF plans, which are part of every investigation’s conclusion.” This iterative cycle ensures devices remain safe, effective, and responsive to evolving patient needs.

Science and compliance: speaking both languages

Medical devices originate in different ways: from academic research spun out into medtech companies, or from the industry identifying a clinical gap and sponsoring investigations. In either case, impartial external expertise is vital.

Balancing scientific curiosity with regulatory compliance for medtech businesses is no easy task. Scientists naturally want to investigate every possible angle of a device’s performance, while manufacturers are eager to bring products to market quickly. 

Regulatory consultants need to act as sparring partners for both manufacturers and scientists. Speaking also the scientist’s language while ensuring that investigations remain regulatory compliant and focused is essential to meet timelines. “Having a scientific background makes a big difference,” Erwin explains. “We speak the language of the scientists, we have PhDs ourselves, but as consultants, we also explain the need to guard the scope and boundaries of the study. We keep the investigation aligned with what regulators and ethics committees approved.”

By bridging scientific ambition with regulatory boundaries, consultants help ensure projects stay compliant, efficient, and ultimately successful. Erwin describes the consultant’s role as keeping both sides aligned: “Scientists are often inclined to explore several sub-questions, but the major question must be directed to the intended use and safety aspects. We are very strict with that, because scope creeping delays approvals and market access. Also, expanding scope is often more easy when product is first introduced and approved with a more limited scope.” 

Meeting international standards for clinical investigations

International standards play a critical role in supporting compliance. For clinical investigations, the cornerstone is ISO 14155, which provides guidance on trial design, statistical validity, and quality system integration. Following the standard not only supports MDR compliance but also enhances credibility with regulators and stakeholders.

While not legally binding, its application is widely recognized as best practice. “ISO 14155 ensures you have the right protocols in place with the right number of patients,” says Erwin. “It prevents situations where data can’t prove your endpoints due to poor design or high dropout rates.” 

Aligning science with compliance

Clinical investigations are the backbone of medical device regulation in Europe and elsewhere. They demand both rigorous science and unwavering compliance. 

With requirements varying by risk class, study type, and geography, the process is complex, but navigable with the right expertise. Regulatory consultants play a crucial role in aligning scientific goals with MDR obligations, ensuring devices reach patients safely and efficiently.

Need support with clinical investigations or any other aspect of compliance with the EU’s MDR? The regulatory experts at Dawn Technology can guide you through every step, from clinical planning to post-market follow-up.