MedTech Europe Calls for Clarification on EDPB’s Proposed DPIA Template
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.
FDA Reports 1,284 Devices Granted Breakthrough Device Designation as of March 2026
The FDA has reported 1,284 Breakthrough Device designations and 198 market-authorised Breakthrough Devices as of March 2026. Learn what this means for medical device manufacturers and U.S. market access strategies.
Kickstart your 2026 Regulatory Strategy with Smart MDR
Did you miss our holiday announcement? Don't worry—there is still time to accelerate your market entry in 2026 with an exclusive advantage. Regulatory compliance shouldn't be a barrier to innovation. At Smart MDR, we are extending our special support for Startups to ensure your medical device, IVD, or SaMD hits the European market faster and more efficiently.
Comece 2026 com o pé direito no Mercado Europeu!
Natal passou, mas a sua oportunidade de levar inovação médica para a Europa com condições exclusivas ainda está de pé! Sabemos que os desafios regulatórios são a maior barreira para Startups de dispositivos médicos, IVDs e softwares (SaMD). Por isso, a Smart MDR decidiu manter nossa condição especial de início de ano para ajudar você a conquistar a Marcação CE em 2026.
European Commission Launches the Digital Fitness Check: Implications for Medical Device Manufacturers
The European Commission has launched a Call for Evidence for its Digital Fitness Check, a major evaluation of EU digital legislation and its impact on competitiveness, innovation and administrative burden. This review is particularly relevant for medical device manufacturers facing overlapping digital, cybersecurity and data compliance obligations across EU rules.