Beitrag von DQS

The clock is ticking for your MDR application! The deadline in May 2024 for an extension is approaching rapidly. According to Amendment Regulation (EU) 2023/607, manufacturers of MDD-certified products can gain more time for certification during the transition phase to the new MDR (EU) 2017/745. However, certain conditions apply: by May 26, 2024, you must submit a formal application for conformity assessment to a Notified Body and be accepted by the Notified Body no later than September 26, 2024. In the last few weeks, many manufacturers have opted to switch to DQS as their designated body and are benefiting from the following advantages of the regulated transition: For custom-made implantable Class III products: until May 26, 2026. For medium and low-risk products: until December 31, 2028. This includes other Class IIb products, Class IIa products, and Class Is, Im, Ir products. For high-risk products: until December 31, 2027. This includes Class III products and implantable Class IIb products. Excluded from this are: wedges, plates, wires, pins, clips, connectors, suture material, staples, dental fillings, braces, dental crowns, and screws. The extension ensures that, in the interest of patient safety, any shortages of medical products are avoided and a reliable supply of medical products can continue. However, due to the complexity of the EU Medical Devices Regulation, urgent action is still required if you are a manufacturer needing to transition to MDR. Contact us now here: https://lnkd.in/dd9pxmbn

The MDR transition extension deadline is quickly approaching - are you prepared to take the next step? DQS is here to answer your questions regarding the transition and process. Visit our website today to learn more about MDR and get connected to move forward in the transition process: https://lnkd.in/gaf5mprv #MedicalDevices #MDR

As we bid farewell to the holy month of Ramadan, DQS extends warm wishes for a joyous Eid al-Fitr to all our clients, partners, and colleagues. 🌙✨ Eid Mubarak! 🌙✨

As we welcome the rejuvenating spirit of spring, a season symbolic of renewal and growth, DQS wishes a happy Easter Sunday to all who are celebrating this occasion! 💐🐣

Last Thursday, March 14, 2024, Annemie Valkeneers (DQS Belgium), Gianluca Nasi and Dr. Oskar Köhle (DQS Medizinprodukte GmbH) visited MEDTech in Brussels and successfully represented DQS there. MEDTech Europe is the European trade association for the medical technology industry, including diagnostics, medical devices and digital health. The aim of MedTech Europe is to make innovative medical technology accessible to more people while putting healthcare systems on a more sustainable path. Five Notified Bodies were represented at this meeting. They were all designated under the MDR and some also under the IVDR. During an interactive panel discussion, where the audience could ask questions, we looked at the current challenges, both for the manufacturers and for us. Gianluca Nasi thanks anyone involved for a successful event. #onedqs #dqs #medical

⚡⚡⚡ EU member states approved the adoption of the EU Corporate Sustainability Due Diligence Directive 💡 EU member states brought an end to a weeks long saga, approving the adoption of the EU Corporate Sustainability Due Diligence Directive - a groundbreaking law that will make history by regulating how large companies active on the EU market conduct sustainability due diligence across (big parts of) their value chains, for a wide range of human rights and environmental impacts. 🚦 After several aborted attempts in past weeks, EU Council vote last friday was successful due to support from key EU member states, in particular Italy and France, whose vote was previously uncertain. 🤝The required qualified majority was found thanks to key diplomatic efforts and significant last-minute concessions agreed by the Belgian Presidency of the Council of the European Union 2024. Beyond the widely reported list of concessions granted last week, ultimately in the final version of the law as voted today, the revenue threshold for applicability was also raised, from 300 to 450 million EUR. ➡ Next: the law now needs to pass a final adoption vote by European Parliament. JURI committee vote could possibly follow as early as March 19th, with Parliament’s plenary vote expected during the April 22-25 plenary. ❗ While the EU Council was widely considered the biggest hurdle, the Parliament vote remains highly uncertain. Its outcome will be largely determined by whether or not conservative groups' determination to block the law will be somehow tempered by the significant concessions granted in past weeks. ⭐ The intense battle that unfolded over the last weeks, resulted in a watering down of the law. Nevertheless, it remains very ambitious, and it is clear that the core of the unique law is preserved: 👉 CSDDD will regulate in clear and detailed terms how the largest companies conduct value / supply chain sustainability due diligence, mandating due diligence based on existing international due diligence standards 👉CSDDD makes those companies liable for impacts they cause 👉the adoption of this law arguably remains the most impactful policy development since the adoption of global - voluntary - due diligence standards. #cs3d #csddd #sustainabilityreporting

🔍 According to the 2021 Global Estimates on Modern Slavery, there are 28 million people trapped in forced labour around the globe. 🚨 While the prohibition of forced labour is already embedded in the EU Charter of Fundamental Rights and multiple other EU legislative initiatives, products made using forced labour continue to circulate on the EU market. 💡 But change is on the horizon: the EU institutions are negotiating a ban on products manufactured using forced labor. Audits and standards play an important role in ensuring that a future ban is effectively implemented and modern slavery is combated. Read more in this blog article by Dr. Thijs Willaert, Global Director Sustainability Services at DQS: https://lnkd.in/eEh5zrtE

As Ramadan begins, we extend our warmest wishes to everyone observing this holy month around the world.

The certification industry is not a "men's world." DQS shows this in an exemplary way. At the heart of our international subsidiaries lies a diverse and powerful workforce, with women constituting 51% of our dedicated employees. Their outstanding efforts demonstrate the pivotal role women play in shaping the industry and promoting excellence - from auditors to technical experts to management. ♀💪   Today, on International Women's Day, it is a matter close to our hearts to celebrate the outstanding contributions of women in all parts of the world. Let us continue to advocate for and embrace gender diversity and inclusion - not just today, but every day!