DLC Clinical Regulatory Unit services include:
- Determination and interpretation of applicable country specific rules in all EU Member States for approval of:
> clinical studies with medical devices
> clinical performance studies with IVD medical devices
> biological sample collection studies
> other types of research settings (e.g. compassionate use procedures)
- Writing / review of submission documents (i.e., study protocol, informed consent, Investigator’s Brochure, Case Report Form, other documents) for compliance with EN ISO 14155, General Data Protection Regulation (GDPR), and country-specific requirements
- Regulatory review of technical documents, such as, Risk Analysis, Instructions for Use, Essential Requirements Checklist, or other documents for compliance with applicable regulatory requirements and/or standards
- Notifications / submissions of clinical study documents to EU Competent Authorities and Ethics Committees
- Submissions of amendments, yearly reports, etc. to Competent Authorities and Ethics Committees, as required
- Certified translations of study documents from / to all European languages
