• 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

• 2025-01-20 06:54:39

Register our FREE Webinar on 2025 Updates & Forecast for European Medical Device Regulations. Keep your medical device compliance in Europe up-to-date!

• 2025-01-22 06:50:55

This document offers a detailed Q&A guide on the progressive implementation of Eudamed, focusing on the gradual roll-out of Eudamed, obligations related to supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2023-11-20 02:49:24

A regulation governing the assignment of Unique Device Identifiers (UDI) for contact lenses has been published.

• 2023-08-23 06:09:04

Due to Regulation (EU) 2023/607, the transition period is extended. Some timelines of the related factsheet or guidance are modified accordingly.

• 2023-04-25 01:59:50

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amends the MDR and the IVDR as regards to the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

• 2023-03-27 09:59:19

This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.

• 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

• 2023-01-19 05:51:33

This guidance is to assist manufacturers to implement the legal requirements related to the Periodic Safety Update Report (PSUR), which has been introduced in Article 86 of the MDR. This guidance provides the detailed information of the PSUR requirements and the related templates.