QT Activity: Webinar Recap | EU MDR 2026 Update: Practical Insights on Transition, Documentation & Compliance Strategy – April/May 2026

• 2026-05-22 02:22:56

As EU MDR expectations continue to intensify in 2026, manufacturers are facing greater scrutiny across technical documentation, clinical evidence, and lifecycle compliance. Qualtech's webinar recap highlights practical insights on MDR transition planning, Annex XVI obligations, notified body expectations, and key compliance priorities shaping EU market access strategies.

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Australia: TGA Issues Reminder on Advertising Rules for Therapeutic Goods: Key Guidelines for Social Media Compliance – October/November 2024

• 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

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EU - MDR: MDCG 2022-11 - MDCG Position Paper Notice to Manufacturers to Ensure Timely Compliance with MDR Requirements – July 2022

• 2022-07-26 11:03:38

Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.

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