Post by DEKRA Certification

🚨 Big changes may be on the horizon for UK medical device regulation — and the Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback from industry stakeholders.   On 8 May 2026, the MHRA published new draft pre-market regulatory requirements for medical devices and in vitro diagnostic devices (IVDs). The proposed Medical Devices (Amendment) Regulations 2026 could reshape how MedTech companies bring products to the UK market, with updates focused on:   🔹 Faster access pathways for innovative devices 🔹 New Unique Device Identification (UDI) requirements 🔹 Greater international regulatory alignment 🔹 Stronger post-market surveillance and transparency   If you work in MedTech, diagnostics, digital health, QA/RA, or healthcare innovation, this consultation is worth paying attention to.   This is an opportunity for manufacturers, healthcare professionals, patients, and industry stakeholders to help shape the future UK regulatory framework before changes are finalised.   📅 Consultation deadline: 19 June 2026 (11:59pm UK time) MHRA invites views on proposed changes to medical device regulation - GOV.UK Pre market medical devices regulation – stakeholder impact survey - GOV.UK   This is an important moment for the MedTech sector, with significant implications for manufacturers, regulatory strategy, market access, and post-market traceability in Great Britain. But are these the right changes for innovation and patient safety? What impacts do you expect for industry?   #MedTech #MedicalDevices #IVD #MHRA #HealthcareInnovation #RegulatoryAffairs #MedicalTechnology #PatientSafety #LifeSciences #UDI