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KARL STORZ SE Co. KG

Das Medizintechnik-Unternehmen KARL STORZ wurde 1945 in Tuttlingen, Deutschland, gegründet und zählt zu den international führenden Anbietern in der Welt der Endoskopie.

Lobbying Activity

Meeting with Paul Speight (Head of Unit Environment) and Carl Zeiss AG

20 Oct 2025 · PFAS restriction

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

Critical areas requiring urgent action in the upcoming targeted revision of the MDR include: 0. Harmonization of definitions across MDR and accompanying legal documents. 1. Proportionate Recertification and QMS Audits Manufacturers call for a shift from full re-assessments to change-based reviews during recertification. Re-certification should focus solely on modifications since the last valid certificate, avoiding redundant reviews of unchanged technical documentation and quality management systems. This would reduce regulatory burden, improve efficiency, and maintain safety standards. 2. Short-Term Legal Measures Stakeholders welcome recent Commission efforts (e.g., Master UDI-DI, eIFU, CI/PS pilots) but stress the need for further urgent legal instruments addressing: Change notification Vigilance coordination Recertification pathways Innovation support Structured dialogue mechanisms These measures are time-critical and should be finalized by year-end to prevent further disruption in device availability and innovation. 3. Expanded WET List for Lower-Class Devices To ensure proportionality and reduce unnecessary clinical evidence burdens, stakeholders advocate for an expanded list of Well-Established Technologies (WET) that includes lower-class devices. These devices, often used in routine clinical practice, should benefit from simplified conformity assessment procedures. The WET list must be regularly updated and legally anchored to provide clarity and predictability for manufacturers and notified bodies. 4. Binding Implementation of Article 61(10) Article 61(10) of the MDR provides a pathway for clinical evaluation based on existing data for certain devices. However, its application remains inconsistent. Stakeholders call for a legally binding framework that obliges notified bodies to apply Article 61(10) where appropriate, with clear criteria and guidance. This would streamline assessments for devices with indirect clinical benefit and reduce unnecessary demands for new clinical investigations.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

Dear EC-Team, please see attached files also submitted to targeted evaluation but here with better resolution.
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