<body><div><figure><img src="https://img.particlenews.com/image.php?type=thumbnail_580x000&amp;url=0hCu2U_0wKGT5fA00" alt="https://img.particlenews.com/image.php?url=0hCu2U_0wKGT5fA00" width="1600" height="900" ><figcaption>European Union flags are pictured outside the European Commission building on Oct. 24, 2014, in Brussels, Belgium. Carl Court via Getty Images</figcaption></figure><h2>Dive Brief:</h2><ul><li>The European Parliament has called for the publication of reforms to the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR) by the end of the first quarter of 2025.</li><li>In a joint motion published Monday, the Parliament asked the European Commission to publish acts that “address the most pressing challenges and bottlenecks” of the regulations and propose “the systematic revision” of the legislation.</li><li>MedTech Europe welcomed the Parliament’s message and issued its own call for the commission to quickly fix the challenges and bottlenecks using “any means that carry sufficient legal weight.”</li></ul><h2>Dive Insight:</h2><p>The joint motion for a resolution published by the Parliament makes the case for quickly changing MDR and IVDR. Significant implementation challenges are leading to delays and resulting in failures to achieve device certification and approval, particularly for small and medium-sized companies, the resolution states. The politicians said the problems are restricting patient access to life-saving technologies.</p><p>Other criticisms include a lack of harmonized procedures across notified bodies in the European Union. The situation has resulted in “unpredictable timelines for certification and market access,” according to the politicians, as well as “inconsistency in decisions and a lack of transparency in relation to the work of the notified bodies.”</p><p>The resolution calls for the commission to propose acts that address the most pressing problems by the end of the first quarter of 2025. In parallel, the politicians want the commission to propose systematic revisions to the regulation as soon as possible.</p><p>Specific ideas include a call to “resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency and eliminate unnecessary administrative work for notified bodies and manufacturers.” The resolution advocates for “transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies.”</p><p>Peter Liese, a member of the Parliament, is one of the authors of the resolution. Liese made the case for swift changes to the regulations during a debate in Parliament in October. Arguing that the new commission should act within 100 days, Liese called the regulations “a bureaucratic monster with loads of rules that do not increase safety, but increase costs.”</p><p>The Parliament’s call for urgent action was well received by MedTech Europe, which put forward similar suggestions last week in a letter to Stella Kyriakides, the outgoing commissioner for health and food safety. MedTech Europe welcomed the Parliament’s focus on providing predictability and eliminating unnecessary administrative burdens, as well as the urgency of the call for change. </p><p>Věra Jourová, vice president for values and transparency at the commission, advocated for a measured approach to reform after hearing Liese push for fast action during the recent debate in Parliament. Jourová warned against a rushed initiative. “We must get this right on the basis of data and analysis, together with the necessary involvement of all the relevant stakeholders,” Jourová said.</p></div></body>

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European Parliament calls for proposals to reform MDR and IVDR by end of Q1

The European Parliament has called for the publication of reforms to the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR) by the end of the first quarter of 2025. In a joint motion published Monday, the Parliament asked the European Commission to publish acts that “address the most pressing challenges and bottlenecks” of the regulations and propose “the systematic revision” of the legislation.