Mölnlycke Health Care AB
Mölnlycke Health Care AB is a private company providing health systems with solutions aimed at improving patients' outcome while being sustainable.
ID: 150331249562-81
Lobbying Activity
Meeting with Michele Picaro (Member of the European Parliament) and MedTech Europe and
20 Jan 2026 · Meeting
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
Mölnlycke is eager to share insights based on its MDR early-adopter experience to inform the forthcoming revision of the Regulation. While the current Medical Device Regulation (EU) 2017/745 is a significant step towards creating uniform legislation for all actors in the medical device sector, there are areas where the European Commission can improve clarity and oversight to ensure the availability of state-of-the-art care to EU citizens while ensuring their protection. Maintain High Standards and Recognise Compliance Reduced Burden for Early Adopters: Manufacturers with a history of strong compliance - demonstrated through robust Quality Management Systems (QMS) and consistently positive technical file reviews should be eligible for a streamlined re-certification. This would involve assessment only of new elements added post-surveillance, acknowledging their sustained compliance and reducing unnecessary duplication. Simplified Access to Innovation: Legislators should establish a shortened re-certification pathway for companies that were early adopters of MDR requirements and have consistently maintained zero non-conformities. By recognising their proactive compliance and investment in quality, legislators can facilitate faster market access for both new and existing technologies. Differentiated Assessment Levels: The NBs should apply distinct criteria and review pathways based on manufacturer's compliance. Early adopters and long-standing compliant suppliers should follow a quicker review path based on their established QMS and technical file structure. This approach encourages innovation while maintaining high regulatory standards. Motivation for Investment: By providing a fast-track re-certification process, manufacturers are incentivised to invest in compliance and innovation. Knowing that their efforts will lead to faster market access creates a positive feedback loop, benefiting both companies and NBs by freeing up resources to focus on emerging technologies. Promote a Unified Approach to MDR Implementation Consistent interpretation: The European Commission should provide clear guidance to NBs and competent authorities on how to interpret the MDR. This will prevent the disparate application of common EU rules in different countries, reducing the need for multiple processes and avoiding delays in bringing best-in-class products to market. Standardised Framework: NBs should clarify timelines and adopt a standardised and digital framework for technical documentation. Common certification process: Harmonising practical MDR requirements allows companies to provide a single set of MDR certificates and certificates of conformity. This streamlines regulatory efforts, ensuring faster access to medical devices for patients across the EU and facilitating and minimising trade barriers within the EU. Streamline Regulatory Processes and Promote Innovation Centralised Supervision: A dedicated organisational structure should be responsible for the implementation of MDR and supervision of NBs. It should possess high levels of expertise in medtech and provide a uniform interpretation of the regulations across the EU, ensuring that classification rules are applied consistently by different authorities and NBs. This aligns with the obligations outlined in MDR paragraph 85. Cohesion and Uniformity: Unambiguous guidance documents uniformly applied across Member States are essential for maintaining cohesion amidst the growing number of regulations in the EU and the MDR. This will help ensure that EU citizens can benefit from innovations in the medical device sector as soon as possible. Clarification and Consistency: A centralised governance ensuring uniform interpretation and implementation of MDR can ensure a regulatory framework that supports innovation and protects public health.
Read full responseMeeting with Peter Liese (Member of the European Parliament) and Steel for Packaging Europe
9 Jul 2025 · Austausch
Meeting with András Tivadar Kulja (Member of the European Parliament)
22 May 2025 · Wound care and surgical procedures