Medical Devices
Description
In this task force, high-level experts in this field discuss the latest developments in the regulatory framework for medical devices. They exchange key insights and interpretations of the EU medical devices framework and identify areas where the BioMed Alliance can provide input and expertise to enhance the safety of medical devices in Europe. They also explore opportunities for reaching out to key stakeholders and organisations in the medical devices field, both within Europe and beyond.
Chair
This task force is chaired by Prof. Alan Fraser and Prof. Per Kjærsgaard-Andersen.
Board Representative
The Board Representative for the Committee is Prof. Sanja Kolaček.
Highlights
News
New Policy Recommendations focus on Key Shortcomings in MDR & IVDR
The BioMed Alliance has released two policy documents which include recommendations of healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, there are certain shortcomings that must be addressed in the evaluation process that is currently ongoing.
Clinicians have raised key concerns, including delays in implementation, the limited capacity of Notified Bodies, high certification costs, delayed roll-out of EUDAMED and reduced patient access to essential devices—particularly for paediatric and orphan devices. Furthermore, increased requirements for diagnostic laboratories under IVDR threaten the availability of essential diagnostics.
To address these pressing issues, the BioMed Alliance calls for urgent action to establish a patient-centred regulatory framework that is transparent, consistent, evidence-based, risk-proportionate, flexible, efficient, and interactive.
BioMed Alliance’s policy recommendations emphasise the need for a new coordinating mechanism to tackle critical systemic challenges, such as:
- Excessive certification costs
- Insufficient clinical evidence and lack of transparency
- Limited access to orphan and paediatric devices
- Increasing risk of devices being withdrawn from the EU market
- Barriers to innovation
- Increasing regulatory complexity
- Fragmented governance
News
Your Expertise Needed: Apply to EMA SAGs and EU MD/IVD Panels
The European Medicines Agency (EMA) is calling for experts to join its Scientific Advisory Groups (SAGs) as part of the upcoming mandate renewal. These advisory groups, managed by the Committee for Medicinal Products for Human Use (CHMP), provide crucial scientific expertise in areas such as quality, clinical, non-clinical, and methodology domains. Experts contribute to scientific evaluations, marketing authorization applications, and the development of scientific guidance documents. Applications for the medicinal products call are open until December 15, 2024. More info available here.
BioMed Alliance also reminds you of the separate call for experts in the fields of In-Vitro Diagnostics (IVD) and Medical Devices (MD) for the European Commission. The demand for expertise in MD and IVD remains critical, as emphasized during our recent Training Day. The need for qualified professionals in these areas is urgent, and this call offers an excellent opportunity to contribute directly to the development of EU regulations, ensuring the safety and efficacy of health products across Europe. ghfghh fghhdfgfghjghjhsdd ghgdf gh sdfh hjhdf sdfh df frd
For more details on the call visit the link here.
Event
Join Us for a Workshop on the Future Directions for EU Medical Devices & IVD Regulations!
Join us for an in-depth workshop focused on the key challenges surrounding the implementation of the Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), particularly in light of the ongoing evaluation process. This event will bring together key stakeholders from across the medical devices landscape to engage in meaningful discussions. We will explore critical issues such as limitations in clinical evaluation, challenges associated with the use of in-house IVDs, and the reduced availability of essential devices in Europe.
In addition to expert presentations, the workshop will feature interactive roundtable discussions where participants will collaborate to identify solutions on the way forward. The event will be followed with a networking cocktail!
Register here!
Event
BioMed Alliance welcomes the introduction of the Q&A of article 10a in the IVD and MD Regulation
We are pleased to welcome the European Commission decision to include the Q&A on Article 10a, "The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices," within the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). This new mechanism aims to create a much-needed framework for managing shortages and ensuring continuity in the availability of critical medical devices across Europe. The Q&A provides guidance on the practical aspects on the obligation to inform about interruption or discontinuation of supply.
As a results of our advocacy activities to protect patients’ access to life-saving devices and diagnostics, earlier this year, we issued a statement highlighting our deep concerns over issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe. The BioMed Alliance warned of widespread challenges due to delayed IVDR implementation, the limited number of certificates being issued, ongoing delays in the EUDAMED database, and general industry unpreparedness. These issues have raised the serious risk of losing essential IVDs from the market, which could compromise patient care and Europe’s competitive standing in the global medical device sector.
To counter these challenges, our January statement called for a mix of short- and long-term reforms, including an urgent extension of the IVDR transition period and targeted updates to the system's framework. The new Q&A guidance of Article 10a provision now provides a structured response to manage supply interruptions, ensuring that information flows effectively between manufacturers, regulators, and healthcare providers.
Article 10a not only reinforces patient access to essential devices but also strengthens Europe’s position in the global medical technology market. We remain committed to further actions that ensure the sustainability and efficacy of Europe’s medical device sector for the future.
Statement
New statement advocates for a balanced approach to phasing out PFAS
In a new statement, BioMed Alliance provides insight on the harmful impacts of Per- and polyfluoroalkyl substances (PFAS) and urges manufacturers of medical devices to find safe alternatives whilst ensuring that essential devices don’t disappear from the market. The statement advocates for a balanced approach for the phasing out of PFAS by advocating for research on finding alternatives as well as facilitating the use of exemptions for a limited time period in order to avoid the loss of medical devices from the market.
Statement
New statement raises awareness on urgent deadline to avoid medical devices from disappearing
In a new statement, BioMed Alliance highlights its concerns regarding an imminent deadline in the Medical Devices Regulation (MDR), which will manufacturers have to meet to keep their devices on the market. It is foreseeable that devices may be withdrawn from the European market in the coming period, which could lead to shortages of medical devices.
As of 26 May 2024, manufacturers will be required to meet a critical deadline for legacy devices, in order to benefit from the extended transition periods. By this date, they will need to have applied for conformity assessment under the new regulation with a notified body, and have a MDR Quality Management System (QMS) in place. Due to several reasons including the high costs of certification, manufacturers may decide not to apply for MDR and their devices will thus not benefit from the extended transition period after the 26th of May. Particularly devices for small patient groups, such as paediatric and orphan devices may be affected. In response, the statement provides both short and long-term recommendations aimed at preventing the potential loss of medical devices.
Statement
Statement raising awareness on urgent deadline to avoid medical devices from disappearing
In a new statement, BioMed Alliance highlights its concerns regarding an imminent deadline in the Medical Devices Regulation (MDR), which will manufacturers have to meet to keep their devices on the market. It is foreseeable that devices may be withdrawn from the European market in the coming period, which could lead to shortages of medical devices.
As of 26 May 2024, manufacturers will be required to meet a critical deadline for legacy devices, in order to benefit from the extended transition periods. By this date, they will need to have applied for conformity assessment under the new regulation with a notified body, and have a MDR Quality Management System (QMS) in place. Due to several reasons including the high costs of certification, manufacturers may decide not to apply for MDR and their devices will thus not benefit from the extended transition period after the 26th of May. Particularly devices for small patient groups, such as paediatric and orphan devices may be affected. In response, the statement provides both short and long-term recommendations aimed at preventing the potential loss of medical devices.