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eBriefing
​MEDICAL DEVICESeBriefing DaaS* · Cloud-based annual access
Updated: December 2024
by eEuropa.org @ 2021-2026 Content & Features
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Summary
Our eBriefing provides a concise and up-to-date analysis of the significant political challenges surrounding the revision of the European Union's Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Initially implemented to enhance patient safety and increase transparency, these regulations have become the center of intense debate among policymakers, industry stakeholders, and healthcare professionals.
Key concerns include:
In response, there are calls for:
The European Commission acknowledges these challenges and has extended transition periods to alleviate immediate pressures while emphasizing that patient safety remains paramount.
This eBriefing offers a detailed examination of these issues and developments. It is continuously updated for one year from the date of subscription, ensuring you have access to the latest insights and policy changes affecting the EU medical device landscape.
Stay informed and navigate the complexities of the EU's Medical Device Regulations with our expertly curated and timely eBriefing.
Key concerns include:
- Bureaucratic Burdens on SMEs: The stringent requirements of the MDR and IVDR are perceived to disproportionately affect small and medium-sized enterprises, hindering innovation and reducing competitiveness within the EU's medical device industry.
- Delays and Device Shortages: Extended certification processes have led to shortages of essential medical devices, posing risks to patient care and potentially exacerbating healthcare disparities across member states.
In response, there are calls for:
- Simplifying Regulatory Procedures: Streamlining processes to reduce administrative burdens without compromising patient safety.
- Accelerated Approval Pathways: Introducing expedited pathways for innovative and low-risk devices to ensure timely access to essential medical technologies.
The European Commission acknowledges these challenges and has extended transition periods to alleviate immediate pressures while emphasizing that patient safety remains paramount.
This eBriefing offers a detailed examination of these issues and developments. It is continuously updated for one year from the date of subscription, ensuring you have access to the latest insights and policy changes affecting the EU medical device landscape.
Stay informed and navigate the complexities of the EU's Medical Device Regulations with our expertly curated and timely eBriefing.
* DaaS, Cloud-Based
This publication is offered as an eBriefing DaaS, combining an updated digital document with 12-month cloud-based access. Subscribers can access both the web version and the PDF version online from computers, tablets or smartphones.
The document is not sold as a static file. It remains an updated eEuropa intelligence resource during the subscription period. Updates may include regulatory changes, new EU guidance, market developments and additional source links.
Access is provided for one year from subscription. Ownership of the document is not transferred; subscribers receive access rights to the updated eBriefing according to the applicable licence terms.
This publication is offered as an eBriefing DaaS, combining an updated digital document with 12-month cloud-based access. Subscribers can access both the web version and the PDF version online from computers, tablets or smartphones.
The document is not sold as a static file. It remains an updated eEuropa intelligence resource during the subscription period. Updates may include regulatory changes, new EU guidance, market developments and additional source links.
Access is provided for one year from subscription. Ownership of the document is not transferred; subscribers receive access rights to the updated eBriefing according to the applicable licence terms.
