Training on the EU Implementing Regulation (EU) 2026/977 and MDR Conformity Assessment Processes

Training Content

This training comprehensively addresses the new rules introduced for conformity assessment activities conducted by Notified Bodies under the MDR, as well as their implications for manufacturers, in accordance with the (EU) 2026/977 Implementing Regulation published by the European Commission.

The training covers proposal preparation processes, maximum time limits set for conformity assessment activities, time extensions (clock stops), the evaluation of significant changes, re-certification processes, performance monitoring mechanisms, and transparency obligations.

Participants will have the opportunity to learn about the obligations, implementation principles, and strategic implications of the new regulation for both manufacturers and notified bodies.

Training Topics

• Purpose and Scope of EU Regulation 2026/977
• New Requirements Introduced for MDR Annex VII Processes
• Draft Preparation and the Structured Dialogue Approach
• SME Criteria and Pre-Application Preparations
• Maximum Durations in Conformity Assessment Processes
• Time Stops and Their Management
• Assessment of Substantial Changes
• Re-certification Approach
• Performance Monitoring and Transparency Obligations
• Transition Process and Implementation Timeline

Who Is It For?

• Medical device manufacturers
• Regulatory and quality professionals
• Technical file preparation teams
• Employees involved in MDR conformity assessment processes
• Authorized representatives
• Consultants and internal auditors

What Will You Gain from the Training?

• Mastery of the requirements of the EU Implementing Regulation 2026/977
• Understanding the new time management rules for MDR conformity assessment processes
• Ability to plan certification and re-certification activities more effectively
• Ability to properly manage time constraints and assessment schedules
• Reducing potential delays in application processes
• Developing application strategies aligned with the expectations of Notified Bodies

Training Dates and Registration

Our training sessions are conducted online. For registration and detailed information, please visit our website or contact us at support@pcatrainings.com.tr.