Insights into Annex XVI – Article 3 of 3: “Prerequisites for a Clinical Investigation of Medical Devices without a Medical Purpose”
Are you planning a clinical investigation in the complex landscape of medical device regulations, particularly concerning products without a medical purpose (Annex XVI, REGULATION (EU) 2017/745 (MDR)? Let Symbio guide you every step of the way.
Some of the Medical Device Annex XVI products (products without a medical purpose), for example dermal fillers, are high-risk medical devices which must undergo pivotal clinical investigations with a design and scope almost similar to that of Phase III studies for drug/medicinal product approval.
Before demonstrating the conformity of an Annex XVI product by conducting a clinical investigation, the following items should be evaluated and/or implemented by the sponsor:
- Familiarize yourself with the regulatory requirements and check standards you can use to demonstrate conformity
- Determine the class of the medical device
- Determine whether a clinical investigation is mandatory for your product
- Establish a certified quality management system
- Carefully plan and conduct the clinical investigation
- Establish a legal representative for the European Union, if applicable
- Familiarize yourself with documents outlined in Annex XV, chapter II of MDR and applicable guidelines, for example MDCG 2024-5 (guidance on content of the Investigator’s Brochure for clinical investigations of medical devices)
Depending on the classification of the product, clinical investigations need to be approved by Regulatory Bodies – National Competent Authorities (NCAs) and Independent Ethics Committees (IECs) – prior enrolling the first subject. Meeting the stringent submission requirements to obtain the permits involves meticulous preparation and documentation.
According to Annex I (3) ff of REGULATION (EU) 2017/745 (MDR), implementing a Risk-Management-System (which is independent from clinical investigations, but should take them into account) for each medical device is mandatory (see also ISO 14971). This should be in place prior to submitting the clinical investigation as it must be part of the technical documentation in the application.
A Clinical Investigation Plan (CIP) is necessary, defining the rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation. This CIP must be accompanied by a synopsis in an official European Union language determined by the member state concerned.
Participating subjects need to be informed about the nature and content of the clinical investigation, documented on the Informed Consent Forms (ICFs).
Symbio’s experienced data management team is capable of programming and analyzing eCRFs and ePROs tailored to your needs.
If you are unsure how to proceed with your medical device, Symbio is available to consult with you and help you determine the best path forward. Symbio is your partner of choice for these kinds of trials, as we have experience ranging from preparation of the required documents (Clinical Investigational Plan (CIP), Informed Consent Forms (ICFs), Patient Reported Outcomes (PROs), and Questionnaires) and application forms through the submission of the study, as well as managing the investigation, clinical monitoring through the preparation and submission of the final report. Please contact us.