Swissmedic’s review of Notified Body Opinions under MDR Article 117 reveals major gaps in documentation quality for drug–device combination products. Updated expectations now apply to ensure compliance with GSPRs.

Swissmedic has released version 3.0 of its swissdamed Business Rules, effective January 2026. The update includes stricter UDI-DI requirements, limits on legacy device data, and mandatory fields for MDR/IVDR submissions. Manufacturers must now align with Swiss-specific data rules diverging from EUDAMED.

The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.

FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.

ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

New FDA guidance clarifies which Clinical Decision Support software functions are not considered medical devices. Key updates affect software developers and manufacturers.

The FDA has updated its guidance on low-risk general wellness devices, clarifying criteria for software, wearables, and lifestyle technologies that may fall outside device regulation. Effective January 6, 2026.

New Swissmedic guidance formalises the process for Scientific GMDP Meetings with Swiss establishment licence holders. Effective January 2026. Download the official document here.

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.

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.

NIST has released its Cybersecurity Framework Profile for AI (Draft, Dec 2025). Learn what this means for medical device manufacturers using AI or ML in their devices.

This regulatory update summarises the Team-NB Position Paper adopted on 12 December 2025, which describes how IVD Notified Bodies will handle conformity assessments following the down-classification of SARS-CoV-2 in vitro diagnostic devices under Regulation (EU) 2017/746 (IVDR). The document reflects the IVD Expert Panel scientific advice published in January 2025 and the subsequent update of MDCG 2020-16 Revision 4, detailing classification changes, certification scenarios, and manufacturer obligations related to SARS-CoV-2 tests.

Brazil’s health authority ANVISA has released the revised 2025 edition of its Manual for the Registration of Health Products, incorporating key regulatory updates for medical device manufacturers. The manual reflects the latest changes under RDC No. 751/2022, RDC No. 848/2024, and RDC No. 556/2021, offering clear guidance on classification, technical dossiers, and grouping rules. This update is essential for any manufacturer placing medical devices on the Brazilian market.

New MDCG guidance on post-market surveillance provides clearer operational expectations for manufacturers under MDR and IVDR. PMS plans must now be more proactive, structured, and integrated into the QMS.

The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.

The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.

The FDA has finalized its 2025 guidance for sponsors on safety reporting in IND and BA/BE studies. Learn what manufacturers must update and how it affects your trials.

Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.

The European Commission released a draft Implementing Regulation aiming to standardise Notified Body practices under MDR and IVDR, enhancing transparency, timelines, and cost predictability.

Release 3.22 of the EUDAMED UDI/Devices User Guide provides updated guidance on MDR and IVDR device registration, UDI requirements, EMDN codes and lifecycle management for manufacturers.