Kiwa participates in the EU Commission High-Level Conference on Medical Devices

A Kiwa speaker is talking at the EU Commission High Level Conference on Medical Devices

On 16 March 2026, the European Commission hosted the High-Level Conference on Medical Devices: Innovation and Patient Safety in Brussels, an event that brought together key institutional representatives, regulatory authorities, industry experts, and stakeholders from across Europe.

The conference represented a strategic moment to assess the current state of the European Medical Device Regulatory system and to explore future developments in the context of innovation, patient safety, and market sustainability.

Alessia Frabetti, Medical Devices Business Unit Manager at Kiwa Italy, actively contributed to the institutional dialogue by participating in the panel “Enhanced predictability for conformity assessments: combining certainty with flexibility.”

Her participation further reaffirmed Kiwa Italy’s commitment to supporting the evolution of the European regulatory framework and to assisting manufacturers in navigating the complexities of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

Kiwa Italy’s Role and Contribution

The participation of Kiwa Italy at this high level conference underscores the organization’s role as a key stakeholder within the European medical device ecosystem. With extensive experience as a Notified Body and a deep understanding of Regulatory and Conformity assessment processes, Kiwa Italy contributes practical, field based insight to policy discussions.

By engaging directly with European institutions and peer organizations, Kiwa Italy fosters a constructive dialogue focused on:

Key points

Patient safety

Reaffirming patient safety as a non‑negotiable priority within the regulatory framework.

Stakeholders' cooperation

Strengthening cooperation among stakeholders to effectively address shared challenges.

Regulatory consistency

Promoting greater harmonization across the European system to enhance consistency and predictability.

Legislative simplification

Supporting legislative simplification to enable innovation while ensuring robust regulatory compliance.

This presence reflects Kiwa broader mission: to act as a trusted Partner for medical device manufacturers throughout the product lifecycle, from regulatory strategy and certification to post market compliance.

Looking ahead

The EU Commission’s High-Level Conference on Medical Devices marked an important step toward shaping the future of medical technology regulation in Europe. For Kiwa Italy, the participation in this forum represents both an acknowledgment of its expertise and a responsibility to actively support the continuous improvement of the regulatory system.

As regulatory developments continue to evolve, Kiwa Italy remains committed to working alongside European institutions and industry partners to ensure that innovation, safety, and patient protection remain at the core of the European medical device framework.

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