MedTechEthics, National Part II CTA Requirements
The resource is written and endorsed by MedEthicsEU, a group of national representatives of Medical Research Ethics Committees in EU/EEA. This document should be read in combination with the Clinical Trials Regulation (EU) No 536/2014 and the information and views it contains are not legally binding for member states or sponsors. It is intended solely to facilitate the submission of clinical trial applications in the member states concerned. A disclaimer further states that the information has not been verified or endorsed by the European Commission and that the overview is a living document to be updated based on information received from ethics committees. Users are directed to EudraLex Volume 10 for additional supportive Clinical Trials Regulation guidance and templates.
The introduction recalls that the Clinical Trials Regulation is applied in the European Union and European Economic Area since 31 January 2022 and sets out rules for submission, assessment, start, conduct and closure of clinical trials. Annex I sections K to R of the Regulation describe the Part II documentation, and the Clinical Trials Information System provides separate placeholders for each section, plus an additional placeholder for compliance with rules on biological samples.
The document clarifies that member states can impose additional documentation requirements based on national legislation or guidelines and that patient facing tools used to assess endpoints should be considered part of the protocol and uploaded under Part I. It recommends following naming conventions for documents as published by the Clinical Trials Coordination Group to support clear structuring of submissions in CTIS. The overview currently covers 21 member states and MedEthicsEU indicates that work is ongoing to complete and update the information as national requirements evolve.
For each country (for example Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovak Republic, Spain and Sweden) the report provides a table structured by CTIS Part II placeholders. These placeholders include recruitment arrangements, subject information and informed consent, suitability of the investigator, suitability of the facilities, proof of insurance or indemnification, financial and other arrangements, compliance with national data protection requirements and compliance with rules on biological samples. Within each row the table lists: required documents; whether EudraLex Volume 10 templates, national templates, both, or no mandatory template apply; the legal basis grouped as Regulation, national law, national guidelines or other; and web links to national regulations, guidance and ethics or authority websites. Footnotes explain codes used to classify template obligations and legal bases.
By consolidating this information, the MedEthicsEU overview supports sponsors, to understand member state specific expectations for Part II documentation, choose the correct templates and locate the relevant national legal and ethical guidance before preparing submissions in CTIS.