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Register by June 30 to secure Early Bird pricing and save up to €300
Summit where Global Manufacturers and Authorised Representatives Align on EU Market Access.
The MDR/IVDR Summit 2026 is built for professionals carrying real regulatory responsibility under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
Hosted by the European Association of Authorised Representatives, the summit brings together global and EU manufacturers, Authorised Representatives, notified bodies, and regulatory leaders to focus on how EU requirements are applied in practice and what it takes to access and operate in the European market today. It is a working forum for those making decisions that carry regulatory, legal, and commercial consequences.
For manufacturers, entry into the EU market is no longer just regulatory. It is operational, legal, and ongoing.
01 |
Enforcement-Driven Insights Understand how MDR and IVDR are being enforced today from the perspective of regulators, notified bodies, and Authorised Representatives. Focus on where expectations are tightening, where companies are falling short, and what this means for both EU and non-EU manufacturers. |
02 |
Clarity on Liability & Accountability Define how responsibilities are shared between manufacturers and Authorised Representatives. Gain clarity on documentation, contractual alignment, and decision-making frameworks required to operate with confidence under increasing scrutiny. |
03 |
Post-Market Surveillance in Practice Move beyond guidance into real-world application. Review how PMS and PMCF are being implemented, what regulators actually expect, and where gaps continue to create risk for manufacturers and ARs. |
04 |
Direct Access to Notified Bodies Engage in direct dialogue with notified bodies on audit failures, documentation gaps, and common compliance breakdowns. Understand how to course-correct before issues escalate into delays, findings, or market access risks. |
From Market Entry to Ongoing Compliance — Get MDR/IVDR Right the First Time
"EAAR's Summit is the one event where I leave with answers I can actually action on and not just frameworks I've seen before."
- Regulatory Affairs Director, EU MedTech Manufacturer, 2025 Attendee
"We’re preparing to enter the EU market, and this Summit gave us a realistic view of what to expect especially around documentation and working with an AR."
- VP Regulatory Affairs, US Manufacturer, 2025 Attendee
Built for the Global MedTech Community
From Market Entry to Ongoing Compliance — Get MDR/IVDR Right the First Time
The summit brings together manufacturers, Authorised Representatives, notified bodies, and regulatory leaders those directly responsible for EU market access and compliance. This creates a focused environment where requirements are not just discussed, but examined through how they are interpreted, implemented, and enforced in practice.
Authorised Representatives
Manufacturers (EU & Non-EU)
Notified
Bodies
Regulatory & Legal Experts
Policy & Regulatory Stakeholders
Bringing the Global MDR/IVDR Community Together
Founded 2002 · Headquartered in Brussels
"An alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence."
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Authorised Representative (Art. 2(32) MDR): Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.— Article 2(32) MDR / Article 2(25) IVDR
About EAAR
The Alliance Behind Europe's Authorised Representatives
The European Association of Authorised Representatives (EAAR) is the professional body representing ARs operating under EU medical device law. Since 2002, EAAR has worked to raise standards of competence and professional conduct across the sector.
EAAR members share a mission: to enhance the quality of European Authorised Representation and ensure all stakeholders understand what AR responsibility truly entails under MDR and IVDR. MDR/IVDR Summit 2026 is the flagship expression of that mission.
Agenda at a Glance - Day 1
10:00 AM: Welcome
11:00 AM: Session Presentations
12:30 PM: Lunch
1:30 PM: Session Presentations
3:00 PM: Networking Break
3:30 PM: Session Presentations
6:00 PM: Evening Networking Reception
MDR/IVDR Summit 2026: Summit Built by ARs for the Global MedTech Community.
Early registration ensures access to the conference at the best available rate and guarantees your place as capacity is limited.
- Secure early bird pricing
- Priority access before the programme is fully released
- Plan participation ahead of peak regulatory and industry timelines
Further programme details, including speakers and session breakdown, will be released in the coming weeks.
2026 Pricing
Save by registering early – rates increase as the event approaches. As always, EAAR Members receive preferred pricing.
Register by 11:59PM ET, June 30, 2026 to take advantage of the reduced ticket price.
Venue & Logistics
Dates |
8–9 September 2026 |
Conference Venue |
Sheraton Brussels Airport Hotel, Brussels, Belgium |
Airport |
Brussels Airport (BRU) — on-site hotel |
Accommodations |
Discounted delegate rate available — Reservation Link will be available by April 15 |
A centrally located venue with direct airport access, designed for convenient international travel.
Need Help?
For answers to conference questions, please e-mail at EAAR@SegmentAgency.com
Get Involved
Align your brand with regulatory excellence — sponsor the MDR/IVDR Summit 2026 and connect directly with Europe's top compliance leaders.
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