GSPR Essentials: Complying with Annex I of the EU Medical Device Regulation

The General Safety and Performance Requirements (GSPR) outlined in Annex I of the Regulation (EU) MDR 2017/745 form the foundation for demonstrating that a medical device is safe, performs as intended and complies with regulatory expectations for CE marking.

This training session is designed to provide participants with a clear and practical understanding of the GSPR framework, its role in the conformity assessment process and how to effectively demonstrate compliance with Annex l of (EU) MDR and document it throughout the product lifecycle.

Whether you are developing a new device, updating existing technical documentation or preparing for a Notified Body audit, a solid grasp of GSPR is essential for maintaining EU market access and regulatory confidence.

Key Topics Covered:

§  Overview of the EU MDR structure with a focus on Annex I (GSPR)

§  Detailed walkthrough of the GSPR clauses, grouped by safety, performance, risk management and labelling

§  How GSPR links to key documentation incl. Clinical evaluation, Risk management, Technical file and Post-market surveillance

§  Demonstrating conformity: Tips for aligning with harmonized standards and Common Specifications (CS)

§  Common pitfalls and audit findings related to GSPR

§  GSPR for legacy and modified devices under MDR transition 

§  Using the GSPR checklist effectively: Documentation best practices 

Benefits

§  Gain a comprehensive understanding of GSPR and its role in (EU) MDR compliance

§  Learn how to systematically demonstrate conformity with Annex I requirements

§  Be equipped to prepare, review, or audit GSPR checklists and supporting evidence

§  Understand how to integrate GSPR into product development and lifecycle management

§  Reduce the risk of non-compliance findings during Notified Body reviews or audits 

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Regulatory Affairs and Quality Assurance Managers, D&D Engineers and Clinical Affairs Managers. 

Trainer: Irenej Polacek