• 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.

• 2026-10-26 09:03:49

The Therapeutic Goods Administration (TGA) has published detailed regulatory guidance to help journalists, media organizations, and sponsors distinguish genuine public-interest news reporting from therapeutic goods advertising. Under the Therapeutic Goods Act 1989, media content that promotes the supply or use of regulated products—either directly or indirectly—is subject to strict advertising rules, including prohibitions on public promotion of prescription-only medicines. This article explores the legal distinction between independent journalism and promotional content, key indicators of unlawful advertising in news formats, statutory exceptions for broadcasters and publishers, and practical case studies provided by the regulatory authority.

• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 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.

• 2026-04-01 07:49:34

Qualtech invites you to a free webinar on April 17, 2026, on mastering Technical Documentation under the EU Medical Device Regulation (MDR). Regulatory expert Dr. Arkan Zwick will share practical guidance on MDR documentation, Annex XVI requirements, legacy device transitions, and working with notified bodies. The session provides valuable insights for all medical device manufacturers currently active in, or planning to enter, the European market.

• 2026-04-01 02:52:37

This webinar recap summarizes a session organized by Qualtech on key EU MDR developments in 2026, including updated transition deadlines, EUDAMED implementation, and new requirements for Notified Bodies, along with upcoming regulatory reforms aimed at improving efficiency, transparency, and innovation.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.

• 2026-01-20 03:48:00

Join Qualtech's free webinar "Expert Insights - EU MDR Updates 2026" on February 12, 2026, to gain practical insights and stay up to date with the most recent developments in the European Medical Device Regulation. This session will assist you and your organization to confidently navigate EU MDR requirements and prepare for the end of the transition period. Stay informed, stay compliant, and turn MDR challenges into opportunities.

• 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!