Understanding the Essentials of Clinical Investigation Under the EU Medical Devices Regulation (MDR): Insights from MDCG 2021-6 Update

Dec 18, 2023 | News |

Understanding the Essentials of Clinical Investigation Under the EU Medical Devices Regulation (MDR): Insights from MDCG 2021-6 UpdateIn the realm of medical devices, the European Union’s Medical Devices Regulation (MDR) stands as a cornerstone, ensuring that devices are rigorously evaluated for safety and effectiveness. The recent update to the Medical Device Coordination Group’s (MDCG) guidance – MDCG 2021-6 Rev.1 – brings crucial clarifications that are vital for anyone involved in the clinical investigation of medical devices within the EU. This post aims to unpack these complexities, offering a clear understanding of the general requirements and key updates. 

  1. Navigating through MDR and National Legislation: A pivotal aspect underlined by the MDCG 2021-6 is the obligation for sponsors to comply not only with MDR but also with any relevant national legislation. This includes procedures for ethics committees, investigator qualifications, and systems for damage compensation. While MDR sets a unifying framework, recognizing and adhering to individual Member States’ legislations remains crucial.
  1. Clinical Investigations and Their Scope: A significant clarification was provided on what constitutes a clinical investigation as per the MDR. Not all studies involving medical devices fall under this category. For instance, a study evaluating a medicinal product, such as a blood pressure monitor device, would not be categorized as a clinical investigation study if the device’s safety or performance isn’t the focus. This distinction is critical in determining the regulatory pathway.
  1. Devices with Medicinal Substances: The updated guidance sheds light on devices incorporating medicinal substances. If the medicinal part is ancillary to the device, it falls under MDR. Conversely, if the medicinal action is principal, the product is governed by specific medicinal product directives. This bifurcation is essential for sponsors in determining the correct regulatory framework for their product.
  1. Combined Studies of Devices and Medicinal Products: Notably, there’s no common EU procedure for studies involving both devices and medicinal products. Sponsors must navigate both the MDR and the clinical trials regulations for medicinal products, adhering to both sets of requirements.
  1. Usability Tests and Retrospective Studies: The guidance also touches on the categorization of usability tests and retrospective studies. The scope, purpose, and exposure of human subjects to the device play a role in determining whether these tests constitute clinical investigations.
  1. Application and Documentation Essentials: MDCG 2021-6 provides detailed insight into the documentation required for clinical investigation applications, aligning with various articles of the MDR. This information is essential for sponsors to ensure compliance and successful application submissions.
  1. Legal Representation for Non-EU Sponsors: A noteworthy point for international stakeholders is the requirement for non-EU sponsors to appoint an EU-based legal representative. This representative is responsible for ensuring the sponsor’s compliance with the MDR, reflecting the regulation's emphasis on accountability and safety.

The MDCG 2021-6 Rev.1 update serves as a lighthouse for navigating the intricate waters of clinical investigations under the EU MDR. For sponsors, manufacturers, and stakeholders in the medical device sector, understanding and applying these guidelines is paramount for successful and compliant clinical investigations. As the medical device landscape evolves, staying abreast of such regulatory updates is not just a regulatory requirement, but a commitment to patient safety and innovation. 

Evita Asumugha – Medical Writer