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COMPANY NEWS

Maria Donawa to speak at the 9th EAAR Annual Conference on 24-25 February 2025

The 9th EAAR Annual Conference on New Medical Device Regulations (RMD 2025) will take place in Brussels, Belgium, on 24-25 February 2025, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the…

Clinical Data Requirements: EU vs. US – Critical Differences and Strategies

On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa spoke at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’. Dr. Donawa was joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin. The webinar was hosted by MedTech Leading Voice…

Maria Donawa posts a second article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’ The topic arises because of confusion among manufacturers, notified bodies, and competent…

Global News

Ideas for medical device regulations overhaul proliferate

One day after the European medtech industry proposed short and medium term actions needed to support public health, patient safety, and the future sustainability of Europe’s health systems, concluding that “broad and comprehensive reforms” were needed, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting discussed similar measures proposed by several member states,…

Medical Device Regulations – Article 10a implementation – EU Commission Q&A published

The European Commission has published a Q&A on the obligation to inform about supply interruptions or discontinuations for specific devices, as required under the new Article 10a of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746). This obligation, introduced by Regulation (EU) 2024/1860, affects manufacturers by mandating notification…

EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision

The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines…