MedTech Europe has responded to the European Commission’s Call for Evidence on future European Partnerships implemented as Joint Undertakings under the next Multiannual Financial Framework.

MedTech Europe has published its position on the European Commission’s proposal to simplify the MDR and IVDR, supporting a more proportionate and risk-based approach to oversight, surveillance and assessment activities throughout the lifecycle of medical devices.

MedTech Europe has responded to the EDPB consultation on the proposed DPIA template, calling for greater flexibility and warning against additional compliance burdens for medical device and digital health manufacturers.

MedTech Europe has published new recommendations for the MDR/IVDR revision, calling for a more proportionate regulatory framework, support for innovation, and improved access to in vitro diagnostics across Europe.

MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.

The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.

MedTech Europe has published its position on the MDR/IVDR revision, supporting simplification measures while warning about new burdens for manufacturers, AI compliance challenges, cybersecurity reporting, and single-use device reprocessing.

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A MedTech Europe defende a simplificação da legislação digital da União Europeia para garantir que o AI Act, o Data Act, a Diretiva NIS2, o Cybersecurity Act e o Espaço Europeu de Dados de Saúde (EHDS) sejam aplicados de forma coerente com os regulamentos do setor da saúde – o MDR e o IVDR. O setor sublinha a importância de evitar duplicação de requisitos, clarificar regras sobre partilha de dados de saúde, reforçar a cibersegurança, proteger segredos comerciais e assegurar prazos realistas para adaptação, garantindo inovação, segurança do paciente e competitividade da indústria europeia de tecnologias médicas digitais.

A MedTech Europe propôs uma nova abordagem para a amostragem técnica no IVDR, com foco na redução de custos para fabricantes de dispositivos de diagnóstico in vitro, especialmente PME. A proposta defende critérios mais proporcionais ao risco, sugerindo reduzir a amostragem para 5% e eliminar a obrigatoriedade de reavaliações técnicas repetidas em dispositivos Classe B e Classe C com histórico estável de vigilância pós-comercialização. Esta revisão permitiria um processo de certificação IVDR mais eficiente, com menor carga regulatória para os fabricantes e melhor gestão de recursos por parte dos Organismos Notificados.

MedTech Europe 's new practical guide to the European Medical Device Nomenclature (EMDN) provides key guidance for medical device manufacturers and IVDs. The correct assignment of EMDN codes is mandatory for registering devices with EUDAMED and for demonstrating compliance with the MDR and IVDR.