Are approvals from the Bioethics Committee and URPL always required?
Not always. The approvals required depend on the type of project and the status of the product involved — whether it is a medicinal product, medical device, dietary supplement, or a purely observational or survey-based study.
At Biostat®, we help sponsors and investigators precisely determine whether a Bioethics Committee approval, URPL notification or only an ethical opinion is needed. This ensures a smooth documentation process and prevents delays caused by formal errors.
General rules:
• Clinical trial of a medicinal product — requires Bioethics Committee approval and URPL notification, in line with EU Regulation 536/2014. Approval must be obtained before patient recruitment begins.
• Clinical investigation of a medical device — requires Bioethics Committee approval and URPL notification, in accordance with MDR 2017/745. This includes verification of technical documentation, safety assessment and the Clinical Investigation Plan. PMCF studies may have simplified requirements but still require approvals.
• Observational (non-interventional) study — generally requires only a Bioethics Committee opinion. No URPL submission is required, but GDPR compliance and appropriate data protection procedures are mandatory.
• Survey projects, registries, retrospective analyses — usually require an opinion from the Bioethics Committee indicating no objections, or a confirmation that the project is not a clinical trial or experiment. The key element is to ensure anonymity or adequate data security.
Many projects, however, fall into a “grey zone” — e.g., hybrid observational-interventional designs or retrospective analyses with clinical assessments — and this is when expert support is crucial.
Biostat® helps interpret regulations and choose the correct formal pathway to avoid misclassification by oversight bodies.
As part of this support, we prepare a complete list of required documents, including:
• the Bioethics Committee application with attachments,
• URPL submission (if required),
• protocol summary for the study registry,
• GDPR and data protection statements,
• investigator and sponsor declarations.
This results in a complete, submission-ready documentation package, minimising delays and resubmissions.
Biostat® understands how complex regulatory procedures can be. Our goal is to guide you from classification to final approval — efficiently, safely and in compliance with regulations.
