Avicenna Alliance
Avicenna
The Avicenna Alliance is a global non-profit organization bringing together health care stakeholders with the goal of making in silico medicine standard practice in health care through a collaborative ecosystem of patients, clinicians, academics, industries, policy makers, regulators payers.
ID: 645734991688-05
Lobbying Activity
Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
The Avicenna Alliance, a non-profit organisation which advocates for the adoption of in silico technologies during the regulatory approval process, welcomes the European Parliaments resolution which calls for measures to address the most pressing challenges and bottlenecks in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The goal is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. We strongly believe that such a goal cannot be achieved without the deployment of in silico methods (or computational modelling and simulation). We are grateful for the EU Commission to do their utmost for resolving these challenges and bottlenecks to facilitate medical innovation in Europe. To achieve this goal, the EC should ensure that new devices reach the European patients as fast as possible without compromising patient safety. Contrary to other regions, unacceptable long delays in Europe are due, at least in part, to regulations not prepared to support innovative methods, such as in silico technologies and its combination with Artificial Intelligence methods, for assessing safety and efficacy of medical devices. Therefore, we urge to take immediate actions to address the most pressing challenges and reduce bottlenecks by: a) reducing and predicting initial assessment timelines and costs, b) making assessments of changes to medical technologies more efficient, c) building an accelerated pathway for breakthrough innovation, and d) adapting certification timelines to follow a life-cycle approach that includes acceptance of in silico methods in the regulatory pathway. Urgent measures are needed to ensure a predictable and efficient certification process to guarantee the timely availability of medical devices in Europe. Accepting digital evidence from in silico trials will greatly contribute to achieve our common goals by reducing costs in clinical trials and accelerating the times to market. The Avicenna Alliance also supports the Parliaments call on the Commission to propose the systematic revision of all relevant articles of these MDR & IVDR regulations, accompanied by an impact assessment; this revision should be conducted as soon as possible. Therefore, we welcome the swift publication of a clear revision timeline and an identification of areas of intervention by the EC, accompanied by a targeted evaluation and result in a full legislative proposal immediately following the final assessment. Our members welcome the specific areas for attention called out in the Resolution, including its focus on bringing predictability, support for innovative and life-saving medical technologies, the support of SMEs and the elimination of unnecessary administrative burdens. In addition, it is critical that a systematic revision of these regulations also include the creation of a single, dedicated governance structure overseeing the regulatory system and ensuring that it remains coherent, sustainable, efficient and impactful for patients. The Avicenna Alliance remains committed and at your disposal to working closely with the EU Commission, EU Parliament, Member States and other stakeholders from industry, academia and patient associations to ensure that the MDR and IVDR meet their objectives and foster a regulatory environment which supports innovation, protects public health and ensures the availability of lifesaving medical devices across Europe. With this objective, we are honoured to hereby provide our first set of proposals of revision of MDR/IVDR with the introduction of acceptance of digital evidence coming from in silico methods in the regulatory pathway, including in silico clinical trials (ISCT), which can be found in the Annex to this letter.
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