The European Commission has published two MDR amendments in 2026 alone. This webinar cuts through the noise and gives you a single, opinionated playbook for how to update your CE strategy this year.
Taevas
UpcomingMedical DevicesPharmaceuticals
EU MDR — What's Changed in 2026 and Why It Matters for Non-EU Brands
A focused 45-minute briefing on the 2026 EU MDR amendments — extended Article 120 transitional periods, the digital UDI pilot, and how Authorised Representative obligations have shifted. Aimed at non-EU brands holding (or seeking) CE marking.
11 June 202645 min2 time zones
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Register nowWhat you'll learn
Four big things you walk away with
Practical, no-fluff takeaways you can act on the same week.
Article 120 extended transition timelines and which classes still benefit
Digital UDI pilot — what to expect operationally in the next 12 months
Authorised Representative obligations under the 2026 amendments
Notified-Body capacity update — where the queues actually are
Agenda
How the 45-minute session runs
Tight, well-rehearsed, and always ends on time.
- 00:00 – 03:00
Welcome and housekeeping
Introductions, attendee map, audio check.
- 03:00 – 12:00
Market context and the regulator lens
Snapshot of growth drivers, recent regulatory shifts, and what changed in the past 12 months.
- 12:00 – 30:00
Step-by-step: licence pathway walk-through
Live walk-through of the documents, dossiers, and decision points an entering brand will face.
- 30:00 – 42:00
Operational realities post-approval
Vigilance, renewals, port clearance, recall procedures, change-control.
- 42:00 – 55:00
Live Q&A
Open-floor questions answered by the speaker.
- 55:00 – 60:00
Closing and next steps
How to book a 1:1 follow-up consultation and access the slide deck.
Hosted by
Meet the speaker
Michael Lambell
EU Pharma LeadUnited Kingdom
Michael leads Taevas' EU pharma engagements from London and acts as Local Representative for over 40 international MAHs. He chairs the Taevas EMA Procedure Forum and has guided Article 57, ICSR, and centralised-procedure submissions across EU member states.
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