Regulatory Reform in IVDR and MDR Is Now a Critical Priority for Europe
Regulatory reform in IVDR and MDR has become a top priority for the European medical technology industry as manufacturers, trade associations, and regulatory experts raise serious concerns over the long-term sustainability of the EU’s medical device framework. In an open letter addressed to European Commissioner for Health and Food Safety, Stella Kyriakides, the industry has urged immediate structural improvements to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Although MDR and IVDR came into force in May 2017, industry stakeholders argue that the regulatory system has failed to achieve its intended goals even after more than six years of implementation.
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Why Regulatory Reform in IVDR and MDR Is Needed Now
According to the open letter, the current MDR and IVDR framework is increasingly unpredictable, complex, slow, and costly. Manufacturers report prolonged conformity assessment timelines, inconsistent interpretations by notified bodies, and limited regulatory capacity across EU member states.
These challenges have accelerated the withdrawal of several medical devices and in vitro diagnostics from the European market, directly impacting patient access to essential healthcare technologies. Small and medium-sized enterprises (SMEs), which drive much of Europe’s MedTech innovation, are particularly affected by the rising compliance burden.
Industry Voices Driving Regulatory Reform in IVDR and MDR
The letter is supported by leading organizations such as MedTech Europe, Austro Med, and F Med, along with multiple national medical device associations. Collectively, they warn that without meaningful regulatory reform in IVDR and MDR, Europe risks losing its position as a global leader in medical technology innovation.
The signatories state:
There is a broad consensus that MDR and IVDR are causing certain products to no longer be available for medical care.
Key Proposals for Regulatory Reform in IVDR and MDR
The industry has outlined three core areas requiring immediate attention:
1. Regulatory Reform in IVDR and MDR Through an Efficient CE Marking System
Manufacturers are calling for a more predictable and streamlined CE marking process to reduce approval delays and eliminate unnecessary regulatory bottlenecks caused by notified body shortages.
2. Regulatory Reform in IVDR and MDR to Support Innovation
A rebalanced regulatory framework is needed to encourage innovation, particularly for novel diagnostics, digital health technologies, and breakthrough medical devices.
3. Single Oversight Authority for Regulatory Reform in IVDR and MDR
The industry proposes the creation of a single, accountable EU-level authority to oversee MDR and IVDR implementation, ensuring consistent interpretation and efficient governance across all member states.
Conference Insights Reinforce Need for Regulatory Reform in IVDR and MDR
Similar concerns were echoed during the Outsourcing in Clinical Trials: Medical Devices Europe 2023 Conference held in Munich.
Deborah Ann Schuster, Clinical Project Manager at Philips, emphasized that MDR technical documentation requirements have become increasingly resource-intensive and time-consuming, stretching regulatory teams and delaying market entry.
Call for Collaboration With the European Commission
Despite strong criticism of the current regulatory framework, the industry acknowledged Commissioner Kyriakides’ remarks at the EPSCO meeting on December 9, 2022, where she recognized the need for structural reform within Europe’s health policy.
The open letter encourages continued leadership from the European Commission and offers full industry support to collaborate on practical solutions that improve regulatory efficiency without compromising patient safety.
Stay ahead of regulatory reform in IVDR and MDR—talk to Operon Strategist today.
Why Choose Operon Strategist for Regulatory Reform in IVDR and MDR?
Operon Strategist is a trusted regulatory consulting partner for medical device and IVD manufacturers navigating complex European regulatory landscapes. Our team brings in-depth expertise in EU MDR, IVDR, CE marking, technical documentation, and conformity assessment strategies, ensuring your products remain compliant while minimizing regulatory delays.
We support manufacturers at every stage—from regulatory gap assessments and notified body readiness to technical file preparation and post-market compliance—helping businesses adapt efficiently to evolving regulatory expectations under MDR and IVDR.
FAQs
What is meant by regulatory reform in IVDR and MDR?
Regulatory reform in IVDR and MDR refers to proposed structural and procedural changes to the European Union’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to improve efficiency, consistency, and market access while maintaining patient safety.
Why is regulatory reform in IVDR and MDR urgently needed?
Regulatory reform in IVDR and MDR is urgently needed due to long approval timelines, limited notified body capacity, high compliance costs, and increasing withdrawal of medical devices and IVDs from the European market, which directly affects patient access and innovation.
Who is calling for regulatory reform in IVDR and MDR?
Leading European MedTech organizations, including MedTech Europe, Austro Med, F Med, and several national medical device associations, are advocating regulatory reform in IVDR and MDR through a joint open letter to the European Commission.
How is regulatory reform in IVDR and MDR expected to impact patient access?
Regulatory reform in IVDR and MDR is expected to improve patient access by reducing unnecessary regulatory delays, preventing product withdrawals, and ensuring timely availability of essential medical devices and in vitro diagnostics across the EU.
What role does CE marking play in regulatory reform in IVDR and MDR?
CE marking is central to regulatory reform in IVDR and MDR, as industry stakeholders are requesting a more predictable, streamlined, and efficient CE marking system to minimize bottlenecks and accelerate market approvals.
