Compliance deadlines, implementation dates, and consultation windows extracted from upcoming EU, UK, Swiss and US health regulation.
Final deadline to submit applications to Notified Bodies for Class D IVDs and ALL IVDD-certified devices. Must have QMS implemented and application lodged to benefit from extended transition period...
Enhanced PMS requirements come into force for ALL medical devices in Great Britain. Manufacturers must implement clearer, risk-proportionate surveillance systems with enhanced data collection, perf...
MHRA's new UK-specific medical device regulations enter into force, replacing current system based on EU directives. Enhanced post-market surveillance, software updates regulation, and AI-enabled d...
The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
News announcement 17 September 2025 Registration - Prevention Matters: Advancing Research and Policy with Human-Centered Approaches (16 October 2025, 11.00–12.30 CEST) Registration - Prevention Mat...
News announcement 28 October 2025 EU Health Policy Platform: Make your voice count - Vote for the 2025 Thematic Networks by 12 November 2025 (2 weeks left!) EU Health Policy Platform: Make your voi...
Joint Clinical Assessments extend to selected high-risk medical devices and in-vitro diagnostics
Digital health app (DiGA) manufacturers must implement continuous performance measurement and reporting (AbEM system) to BfArM. Results published in DiGA directory. Up to 20% of reimbursement price...
News announcement 17 November 2025 SCCS - Scientific advice open for comments on hair dye ‘Basic blue 99’ (C059) - Submissions IV & V (deadline for comments: 19 January 2026) SCCS - Scientific advi...
News announcement 17 November 2025 SCCS - Scientific advice open for comments on hair dye ‘Basic Brown 16’ (C009) - Submission V ter. (deadline: 19 January 2026) SCCS - Scientific advice open for c...
News announcement 17 November 2025 SCCS - Scientific advice open for comments on Butylated Hydroxyanisole (BHA) - deadline for comments: 19 January 2026 SCCS - Scientific advice open for comments o...
DiGA reimbursement model shifts to outcome-based pricing where up to 20% of price calculated based on demonstrated success. Manufacturers must provide evidence of positive healthcare effects. Strea...
MHRA transitions from one-time device registration fees to annual category-based model. Manufacturers must update/verify registrations before March 30, 2026, then pay annual fees via DORS system wi...
Historic revision of EU pharmaceutical legislation expected to conclude trilogue negotiations. Major changes include: modified regulatory data protection periods (6+2 years base, up to 12 years wit...
How to apply for a clinical trial from 28 April 2026, including eligibility, phases, model IMPDs, costs and how to make changes to your application.
New streamlined Combined Review process for UK clinical trials begins. Single application for MHRA and REC approval, maximum 100-day review timeline, mandatory trial registration and results public...
First phase of EUDAMED database becomes mandatory 6 months after Official Journal publication. All manufacturers must register as economic actors and register devices in UDI/Device module. National...
All health data hosting providers must comply with updated HDS (Hébergeur de Données de Santé) certification standards. Digital health companies processing French patient data must use HDS-certifie...
MHRA seeks stakeholder evidence on proposed GB pre-market medical device/IVD regulation changes to inform impact assessment; deadline 11:59pm Fri 19 Jun 2026.
Αναρτάται, σήμερα Δευτέρα 13/7/2026, στην ιστοσελίδα του ΕΟΦ αρχείο με τις προτεινόμενες προς διαβούλευση ενδεικτικές λιανικές τιμών των ΜΗΣΥΦΑ προϊόντων,
“Παρακαλούνται οι φαρμακαποθήκες όπως δηλώσουν τα αποθέματά τους την Τρίτη 21/07/2026 και ώρα 11:30πμ στην on-line ηλεκτρονική εφαρμογή «Δήλωση Αποθεμάτων
23 Jul 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026 Online Start date: 23 July 2026, 09:30 (CEST) End date: 23 July 2026, 10:30 (CEST)
08.05.2026
News announcement 24 June 2026 Eudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026) 1 min read
This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IP...
10.03.2026
Stručné zhrnutie záverov zo zasadania Výboru pre hodnotenie rizík liekov (PRAC), ktoré sa uskutočnilo 8.–11.6.2026. Plné znenie správy sa nachádza nawebovej stránke Európskej liekovej agentúry.
12.05.2026|Oznamy držiteľov - DHPC|Bezpečnosť liekov|Pre odborníkov a firmy