MDCG releases guidance to assist medical device manufacturers

The European Commission’s Medical Device Coordination Group (MDCG) has just released a guidance to assist medical device manufacturers submit the necessary documentation to support clinical investigations that is part of the Investigator’s Brochure (IB).

The guidance applies to clinical investigations as defined by the Medical Device Regulation (MDR) and is not intended to clinical investigations for in vitro diagnostics.

The guidance is intended to “preempt questions” from the competent authorities in assessing clinical investigation applications and is aligned with MDR and ISO 14155:2020 requirements. MDR’s Section 2.7 of Annex XV requires investigators have access to technical and clinical data regarding the device that is being investigated.

The guidance provides a comprehensive list of information that manufacturers should submit to authorities. It covers administrative information, information on the device’s clinical performance, information on device labeling, and a summary of preclinical and clinical information on the device.

Manufacturers should provide a summary of the literature, previous research and evaluation supporting the rationale for the design and intended use of the investigational device, and to describe the critical and fundamental design of the relevant components of the device to achieve is intended performance.

The guidance states that “the description should be as clear and fundamental as reasonably possibly, not assuming that all intended readers are already experts in the field.”

The brochure should include labels and instructions for use, including a manufacturer’s instructions for installation and maintenance, and any storage and handling requirements.

Sponsors should also submit the results of preclinical testing, including in vitro tests, ex vivo tests, animal tests, as well as the results of clinical data from the scientific literature relating to the device’s safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and or similar devices.

Additionally, manufacturers should provide a summary of the device’s benefits and risks, as well as information regarding any undesirable side-effects, contraindications, and warnings.

Sponsors should also submit an Anticipated Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs), which should be based on internal risk management documents. Manufacturers are also asked to provide detailed information on quality aspects required for the competent authority’s assessment in a separate document.

Lastly, sponsors were advised to consult the checklist in the document’s Appendix A to ensure the IB meets the minimum requirements. RAPS.org