Results clinical investigations for conformity purposes or PMCF investigations
The following applies to the reporting of the results of clinical investigations for conformity purposes (MDR article 62 or 74.2) or post-market clinical follow-up (PMCF) investigations (MDR article 74.1):
- The sponsor is required to submit a clinical investigation report within one year of the end of the study. The requirements for the clinical investigation report can be found in MDR annex XV (section 2.8 of chapter I and section 7 of chapter III). Relevant information can also be found in annex D of ISO-14155-2020. See also MDCG 2021-6.
- The sponsor is required to submit a lay summary of results within one year of the end of the study.
- Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it will be submitted as soon as it is available. The clinical investigation protocol (CIP) specifies when the results of the clinical investigation are going to be available, together with a justification. The review committee assesses whether the extended deadline is justified.
- Has the investigation been suspended or terminated prematurely? If so, a deadline of three months instead of one year applies for submitting the investigation report and the lay summary.
- Has the investigation been suspended and resumed within three months? If so, the sponsor does not need to submit an investigation report and a lay summary. See MDCG 2021-6.
When Eudamed is fully operational, you are required to upload the results of the investigation in Eudamed; the investigation report and the lay summary will be published via Eudamed (MDR article 77.7).
As long as Eudamed is not operational, you are required to submit the investigation report and the lay summary directly via the Research Portal. The data marked by a globe and the document 'M2a. For publication (lay) summary of results' are published in the Overview of Medical Research in the Netherlands (OMON) and the International Clinical Trials Registry Platform (ICTRP), unless the sponsor has objected against disclosure.
A sample form is available that showcases the questionnaire
Please note: this form is only a sample template of the questionnaire you are required to fill in online. It cannot be filled in or submitted in this format.