The development and approval of medical devices under the Medical Device Regulation (EU) 2017/745 (MDR) require not only technical expertise but also critical medical knowledge. This is where the role of the Medical Expert becomes essential.

But what exactly are Medical Experts, what are their responsibilities, and why is their expertise so important for clinical evaluation? In this text, we outline the key aspects and requirements for Medical Experts involved in the clinical evaluation of a medical device.

What is a Medical Expert?

A Medical Expert is a medically qualified professional with extensive experience in the clinical use of medical devices. Typically, they are practicing physicians with sufficient (at least five years) experience in the relevant medical field, preferably with familiarity in the specific or similar medical devices being evaluated. For this reason, manufacturers often seek external experts to support their evaluations.

Why is a Medical Expert Needed?

The requirements for the clinical evaluation of medical devices are regulated by the MDR in Article 61 and Annex XIV, Part A.
More detailed descriptions of the qualifications required for authors of clinical evaluations can be found in MEDDEV 2.7/1 rev. 4 (2016). Generally, authors of clinical evaluations should have expertise in research methodology, information management, medical writing, and regulatory requirements. Additionally, for the medical device being evaluated, they must demonstrate knowledge of the device’s technology and application, the diagnosis and management of the condition targeted by the device, and knowledge of medical alternatives.

It may be necessary to involve a Medical Expert in preparing the clinical evaluation in order to meet the required knowledge, particularly in the diagnosis and management of conditions and alternative medical solutions. This will ensure that the team demonstrates the required expertise.

The Role of the Medical Expert in Clinical Evaluation

A Medical Expert ensures the accuracy and completeness of medical statements in the clinical evaluation, thereby guaranteeing the correct presentation of information and conclusions. If critical aspects are missing or unclear, the Medical Expert contributes their specialized knowledge to address these issues.

Defining Responsibilities

A common question is whether a Medical Expert needs to be familiar with the technical details of the medical device. In practice, their role focuses exclusively on the medical aspects of the evaluation. The responsibility of the Medical Expert is limited to ensuring the correctness of medical and clinical information. Technical and regulatory aspects are managed by other team members.

The clinical evaluation is signed by all team members to demonstrate the required overall expertise. Thus, the Medical Expert does not bear overarching responsibility like the manufacturer but is accountable solely for the accuracy of their medical statements.

Conclusion

The role of the Medical Expert is critical for the clinical evaluation of medical devices. With their specialized medical knowledge, these experts ensure the accuracy of clinical information and complement the technical and regulatory expertise of the team. For physicians, this role offers the opportunity to contribute to the development of innovative products while gaining valuable insights into the world of medical technology and regulatory compliance.

With our extensive experience in the medical technology industry and in-depth knowledge of the MDR and other regulatory frameworks, we are your reliable partner for the clinical evaluation of your medical devices. We are happy to support you in creating the right balance of technical, regulatory, and medical expertise within your team. Let’s work together to ensure that your product is safe, effective, and successfully brought to market.