Insights into Annex XVI – Article 1 of 3: “Designing the Investigator’s Brochure”

June 4, 2024

Are you planning clinical investigations with medical devices or products listed in annex XVI of the MDR? Symbio Proinnovera offers tailored services for such endeavors!

To maintain a high quality of the submission dossier for obtaining authorization for clinical investigations by the National Competent Authorities (NCAs), a crucial step for class IIa/b (invasive) and class III medical devices (- national requirements can be more stringent), Symbio Proinnovera’s Regulatory Department is constantly checking news and updates on laws and guidelines.

This article highlights the “guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – MDCG 2024-5,” recently published by the Medical Device Coordination Group (MDCG). The guideline is helpful in creating the Investigator’s Brochure, a key document in the submission package to NCAs, and helps avoid queries in the submission process.

This guideline is also applicable for products listed in Annex XVI of REGULATION (EU) 2017/745-Medical Device Regulation (MDR). Annex XVI lists products without an intended medical purpose which are nevertheless covered by MDR.

The guideline is valuable especially for manufacturers of Annex XVI products who may be confronted with the creation of an Investigator’s Brochure for the first time. For example, are you unsure how to present the clinical benefit of your product if it has no medical purpose? You will find the answer in the guidance – you focus on the performance of your device.

Symbio Proinnovera’s experienced Regulatory Affairs Department will be happy to assist you in compiling application dossiers and preparing you in advance for potential queries from the National Competent Authorities.

If you have further questions about the content of the submission dossier for medical devices or products falling under Annex XVI of the MDR, please reach out to us for support tailored to your needs.