The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

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This week brings major medical device developments and several important medicines updates.

👀 This Week’s Highlights

🇪🇺 EUDAMED - Mandatory Use Confirmed (OJEU Notice Published 27 Nov 2025)

Why this matters: This is the biggest MDR/IVDR milestone in years - EUDAMED finally becomes operational with legally binding timelines.

The European Commission has confirmed that four EUDAMED modules are fully functional, supported by an independent audit.
The Official Journal publication on 27 Nov 2025 activates a 6-month transition period.

🔹 Mandatory from 28 May 2026

The following modules become compulsory:

• Actor Registration
• UDI / Device Registration
• Notified Bodies & Certificates
• Market Surveillance

🔹 What happens next?

• Vigilance module: separate audit in Q4 2026
• Mandatory use expected:Q2 2027

Manufacturers should now begin aligning data readiness, internal systems, and submission processes with the mandatory workflows.

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🇨🇭 Swissmedic - swissdamed Service Agreement v3.0 + New “Playground” Environment

Why this matters: Manufacturers now have a dedicated testing environment to train teams and validate swissdamed processes before real submissions.

Swissmedic has published Version 3.0 of the swissdamed Service Agreement with a new chapter:

🆕 Chapter 10 — “Playground swissdamed”

A voluntary testing environment for:

• training,
• process testing,
• submission simulations.

Notes:

• For testing only; no contractual claims.
• Swissmedic may limit data visibility or retention.
• Dedicated User Guide available.

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🇪🇬 Egypt - New Medical Device Vigilance Guideline (2025)

Why this matters: Egypt now has a comprehensive, internationally aligned vigilance framework — crucial for manufacturers, importers, and local reps.

The Egyptian Drug Authority has published the Guideline for Medical Device Vigilance System (2025) — a full national framework defining:

🔹 Key components

• Scope, definitions, and system structure
• Roles of users, manufacturers, safety officers
• Incident reporting rules
  • reportable criteria
  • timelines
  • required documentation
  • reporting channels
• Post-market surveillance requirements
  • PMS plan
  • PMSR
  • PSUR
  • trend reporting
• FSCA + FSN guidance
• 13 annexes, including templates for MIR, PSR, trend reports, FSCA plans, examples of abnormal use, etc.

This document significantly improves transparency, traceability, and harmonization with international vigilance practices.

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🇿🇲 Zambia — Local Responsible Person Now Required for All Foreign MAHs​

Why this matters: Companies operating in Zambia must ensure local accountability structures are in place - a key shift for PV compliance.

ZAMRA now requires all foreign-based applicants and MA holders to appoint a Local Responsible Person, in line with Statutory Instrument No. 79 of 2019.

🗓 Deadline:31 December 2025

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🇱🇹 Lithuania — VVKT PV System Questionnaire for Annual Inspections

Why this matters: VVKT continues shifting toward a risk-based inspection model, with MAHs required to proactively submit key system data.

VVKT has launched a 9-section pharmacovigilance system questionnaire for MAHs ahead of annual inspections.

🗓 Deadline:05 December 2025

📩 Submit to: anketa.fb@vvkt.lt

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🇨🇭 Switzerland - Updated PSUR Submission Form v4.1

Why this matters: Using outdated forms can trigger administrative delays.

Swissmedic has released Version 4.1 of the PSUR submission form (MU103_10_002), effective 01 Dec 2025.

• Key change: editorial corrections in Section 2

Ensure your teams are using the latest version.

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Other Updates in Brief

🇪🇺 EMA — IRIS Roadmap (Epic 3)​
Planned IRIS improvements for 2025–2027 covering regulatory-procedure workflows.

🇪🇺 EMA — Post-Authorisation Procedural Advice (Rev. 114)​
Updated Q&As impacting PSUSA, PASS, PAES, RMPs, variations, and post-authorisation measures.

🇬🇧 MHRA — Clinical Investigation Guidance Update (24 Nov 2025)​
Revised GB investigation flow chart, expanded examples, NI performance-study guidance, and updated biological-safety links.

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Until next week - stay compliant, stay curious.

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⚖️ Disclaimer
This newsletter is for informational purposes only and does not constitute professional or legal advice.
All summaries are based on publicly available regulatory information. Always verify requirements with the relevant authority or qualified professional before implementation.
RegIntelHub assumes no liability for actions taken based on this content.