• 2026-11-09 04:27:21

Qualtech invites you to join our free webinar on Thursday, November 26, 2026, with the topic "Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market". In collaboration with Spain-based CRO Iberania, our invited regulatory expert and guest speaker will share practical insights into the clinical evidence requirements under the EU MDR and how to best conduct clinical investigations in Europe, so that successful market access and regulatory compliance can be ensured.

• 2025-01-22 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 2024-06-20 05:24:57

This guidance outlines the requirements for sponsors submitting applications for clinical investigations and supports sponsors in developing the Investigator's Brochure.

• 2024-05-08 02:32:34

This guidance provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.

• 2024-03-01 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices.

• 2023-06-28 09:38:06

This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.