The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.

A nova proposta do Team NB visa reforçar a coordenação através da criação do Medical Device Coordination Office (MDCO), promovendo maior harmonização, eficiência e transparência. A iniciativa também destaca a importância de mecanismos robustos de vigilância do mercado, avaliação científica e apoio à inovação, com especial atenção a dispositivos órfãos e pediátricos. Este avanço poderá representar uma evolução significativa na aplicação do MDR e IVDR, oferecendo uma estrutura mais sólida para garantir a conformidade regulamentar em toda a União Europeia.

The MDCG has published guidance 2025-4, which clarifies the responsibilities of manufacturers of software as a medical device (MDSW) and operators of online platforms that make these apps available in the European Union. The guidance addresses the application of the MDR, the IVDR and the Digital Services Act (DSA), and reinforces labeling, traceability and transparency requirements. Smart MDR supports manufacturers and platforms in regulatory compliance and adaptation to the new obligations of the European digital market.

Implementing Decision (EU) 2025/681 introduces six new harmonized standards under the Medical Devices Regulation (MDR), directly impacting manufacturers of single-use medical gloves, sterile devices and ambulance patient transport equipment. Compliance with these standards allows presumption of conformity with the essential requirements of the MDR, facilitating CE marking and access to the European market. Smart MDR supports manufacturers in reviewing technical documentation, assessing regulatory impact and adapting processes to the new European legislation.

Smart MDR offers support via WhatsApp for manufacturers of medical devices, IVDs and medical device software looking for support with CE Marking and European regulations. Talk to an expert consultant and accelerate access to the European market with confidence.

With the entry into force of the IVDR, rapid antigen tests for COVID-19 are now classified as Class D devices, requiring assessment by a Notified Body.