EU Medical Device Expert Panels Offer Guidance on Clinical Development Strategy and Investigations

Regulation:
Under Article 61(2) of Regulation (EU) 2017/745, medical device manufacturers can seek scientific advice from expert panels on clinical development strategies and investigations.

Scope and Requirements:
Applicants must submit detailed information, including:

• Administrative details and device name
• Risk classification and justification
• Relevant clinical areas and regulatory status
• Novelty, potential clinical impact, and product development history
• Specific questions for expert panel review
• Process and Implementation:
• The expert panel will evaluate the application and provide guidance to ensure compliance with regulatory requirements and best clinical practices.

This initiative aims to enhance patient safety and the effectiveness of medical devices while streamlining regulatory processes for manufacturers.

Region: European Union

Source: https://www.ema.europa.eu/en/documents/other/request-advice-clinical-development-strategy-or-clinical-investigations-according-article-612-regulation-eu-2017-745-medical-device-expert-panels_en.pdf