Healthcare professionals rely on medical devices to protect and monitor the patient’s health as well as to provide treatment, diagnosis, and rehabilitation. Medical devices, however, can be a significant source of exposure to harmful chemicals such as endocrine disrupting chemicals (EDCs).
The new Medical Devices Regulation (MDR) entered into force on 26 May 2017. It aims to strengthen the EU’s legislation for medical devices and offers a real opportunity to speed up the process of phasing-out harmful chemicals, increase the availability of safer medical devices in the EU, and to better protect patients and healthcare professionals.
Health Care Without Harm Europe has been actively following the development of the MDR since 2004 to support the use of safer medical devices in healthcare. We hosted a webinar on 27 September to discuss its implementation, as well as increase awareness of the new European Database for Medical Devices (EUDAMED) and to hear the perspective of industry and Notified Bodies.
The MDR is not an amendment of current directives, but a regulation aiming to implement new requirements focused on quality and safety standards of the devices, support of clinical data, as well as strict control by Notified Bodies, national competent authorities, and the European Commission.
The EUDAMED database will publicly gather all available market information on the lifecycle of medical devices. Devices listed on EUDAMED must pass rigorous checks, validations, and clinical trials to ensure their quality and safety. The goal of the database is to ensure transparency and strengthen safety requirements by registering the medical devices authorised for use in the EU market and will be accessible to Competent Authorities, the Medical Devices Coordination Group (MDCG), Notified Bodies (NBs), Economic Operators (manufacturers, authorised representatives, importers, sponsors), as well the public and healthcare providers.
When fully functional, EUDAMED has a crucial role in guaranteeing safer medical devices on the EU market. Initially planned to go live in May 2020, the newly announced timeline expects EUDAMED to be fully operational in Q2 2026.
A recording of the session and featured presentations are available below.
In this webinar we:
- Offer an overview and update on the MDR implementation.
- Increase healthcare professionals' knowledge of the EUDAMED database and its state of play.
- Share the perspectives from industry and Notified Bodies to understand their challenges and future developments.
Katia PACELLA, Circular Healthcare Projects Officer - HCWH Europe
Katia holds an MSc in Planning and Management of Agro-territorial, Forest and Landscape Ecosystems with a focus on chemical pollution and Environmental Management from the University of Bologna. She has extensive technical knowledge in chemical pollution and working experience in soil, water, and groundwater remediation.
Oliver BISAZZA, Director, Regulations & Industrial Policy - MedTech Europe
Oliver leads the Industrial Policies department, which supports members in their implementation of the new and changing EU regulatory requirements, including legislation linked to the European Green Deal, the HTA Cooperation Regulation, in vitro Diagnostics Regulation and the Medical Devices Regulation. His team strives to facilitate ‘technical implementation’ of regulations in place across the EU and to communicate the positions of the MedTech Europe membership. When not working on EU regulations, Oliver also coordinates the activities of MedTech Europe’s Cardiovascular Sector Group.
Prior to joining MedTech Europe, he worked at Medtronic as Director of Regulatory Policy for EMEA. In addition to this company experience, Oliver has had trade association roles in Brussels, at COCIR (the European association for the radiological, electromedical and healthcare IT industries) and at EDANA (the industry association for the nonwovens and related industries).
Françoise SCHLEMMER, Director - Team NB
After a master's degree in biochemistry, Françoise worked for Medical Device Manufacturers, a Notified Body, set up a consultancy office, and became Team-NB director in 2001. She conducts conferences on the trends of the new European regulations.
Team-NB is an association that brings together 30 notified bodies in the medical devices sector. These members issue more than 80% of the certificates worldwide. Team-NB is actively pursuing to encourage the continuous improvement and development of products, allowing patients increased access to safe yet innovative devices. In this aim, Team-NB is involved in the implementation of the two new Regulations. Team-NB is also aiming to develop harmonisation of best practices among their members.
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