Regulation

Accelerating EUDAMED Rollout: Key Dates and Requirements for Medical Device Manufacturers

The Complete EUDAMED 2025–2026 Compliance Timeline: What Medical Device Manufacturers Need to Know to Successfully Navigate EUDAMED Requirements Before the 2026 Deadlines.

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NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen

Hall 2 / B 2066

MIK - MDR- & IVDR-Competence Centre

The strict regulations on medical devices (MDR) and in vitro diagnostics (IVDR) often pose major challenges for the industries concerned. As a competence center, MIK offers consulting and development capacities and is oriented towards the needs and requirements of the industry.

Ackomas

Hall 2 / C 2079a

SWISSDAMED: Switzerland’s Medical Device Database

Following the termination of the Mutual Recognition Agreement between Switzerland and the EU in 2021, Switzerland had to adapt to ensure safety standards equivalent to those of the EU. In this context, Swissdamed was born: a national database dedicated to medical devices and in vitro diagnostics.

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ERNI Schweiz AG

Hall 2 / A 2028

Powerful and regulatory-compliant medical device software (MDSW) from a single source

Medical device software (MDSW) must not only be technically convincing but also regulatory compliant – this requires experience, expertise, and a well-coordinated team. This is precisely where our partnership between ISS AG and ERNI Schweiz AG comes into play.

Metecon Schweiz GmbH

Hall 2 / F 2158

Software, AI, and Regulatory Affairs with Metecon: Everything from a single source

Medical devices with software components are subject to complex regulatory requirements. At Metecon, we guide you through this complexity – from the software development lifecycle to CE marking, from EN 62304 and EN IEC 81001-5-1 to the AI Act.

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Metecon Schweiz GmbH

Hall 2 / F 2158

Story

"There are many regulatory compliance providers – so why Metecon?"

Simple: Because we don’t just know what needs to be done – we know how to do it. Together. Whether MDR, IVDR, EC-REP, software validation, or clinical evaluation – at Metecon, more than 60 experts from all regulatory disciplines work hand in hand: with expertise, heart, and conviction.

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Ackomas

Hall 2 / C 2079a

Differences Between EUDAMED and GUDID: What Manufacturers Need to Know

For medical device manufacturers operating internationally, navigating multiple regulatory databases can be complex. While both databases share a common goal, they have fundamental differences that manufacturers must understand to ensure regulatory compliance.

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Metecon Schweiz GmbH

Hall 2 / F 2158

Between Benefit and Burden: How much regulation still makes sense?

Regulations, guidance documents, standards, annexes, specifications…What was once intended as a helpful framework now feels to many manufacturers like an overengineered system full of rules, redundancies, and well(?)‑intentioned details. So what is truly necessary – and what could (finally) go?

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teltec systems ag

Hall 2 / A 2027

Safe Marking for Medical Devices: Quality That Builds Trust

In medical technology, every detail matters—especially when it comes to permanent and reliable product marking. Only a precise and validated mark ensures traceability, product safety, and regulatory compliance.

Solectrix GmbH

Hall 2 / A 2008

Your partner for the entire medical technology product life cycle

The path from the initial idea to an approved and successful medical product is a long one, accompanied by ups and downs. Regulatory requirements are not obstacles, but guidelines that ensure safety, quality and sustainability.