Brussels, Europe – November 28, 2025Â New data presented by the European Commission’s monitoring study has revealed a dramatic impact on the medical device market, showing that nearly half of manufacturers have already pulled products from the EU market rather than navigate the complex transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
The findings, based on the 2nd Economic Operator (EO) survey with data current as of October 31, 2024, paint a clear picture of an industry struggling with compliance burdens, directly informing the EU’s recent move to impose strict rules on supply interruptions.
THE EU DEVICE AVAILABILITY SURVEY : KEY IMPACTS ON YOUR PORTFOLIO
The survey results highlight critical challenges for medical device manufacturers (MFs) and IVD manufacturers (IVD MFs):
- Mass Product Discontinuation: A massive 48% of Medical Device Manufacturers (MFs) reported stopping the production or marketing of at least one device since the MDR came into application in May 2021.
- IVD Market Shrinkage: The In Vitro Diagnostic (IVD) sector faces similar pressure, with 40% of IVD manufacturers discontinuing products since May 2022, and 37% planning to discontinue even more in the coming months.
- Threat to Niche Devices: These cuts are disproportionately impacting specialized products, with 17% of discontinuing IVD manufacturers affecting orphan or niche devices.
Certification Race Against the Clock
Despite multiple extensions to the transitional periods, the certification rate remains a significant bottleneck, suggesting that manufacturers are still racing to secure the necessary approvals:
- MDR Slowdown: As of October 2024, only 22% of medical device manufacturers had achieved certification for more than 90% of their product portfolio requiring an MDR certificate.
- IVDR Progress, But Gaps Remain: While the IVD sector is slightly ahead, only 56.1% of devices requiring IVDR certification had achieved it by the same date. The recent IVDR deadline extensions were acknowledged by 57% of IVD MFs as having impacted their transition decisions, offering much-needed breathing room.
DIRECT GUIDANCE: THE NEW MANDATORY SUPPLY RULES
The high rate of product discontinuation has prompted a direct regulatory response that immediately impacts how manufacturers must operate: mandatory advance notification for supply interruptions.
To mitigate the risk of patient harm from unexpected product shortages, the EU enacted Regulation (EU) 2024/1860. This legislation directly targets the market volatility documented in the latest availability study.
YOUR NEW OBLIGATION: THE SIX-MONTH WARNING
Effective January 10, 2025, manufacturers are legally required to provide a minimum of six months’ written notice to Competent Authorities and relevant healthcare institutions before any planned discontinuation or interruption in the supply of medical devices or IVDs.
This new obligation for device manufacturers is designed to:
- Enhance Transparency: Provide detailed justification for the interruption, the expected date, and the current stock situation.
- Enable Preparation: Give healthcare systems time to source or qualify alternative devices.
WHAT THIS MEANS FOR EU MARKET ACCESS FOR MANUFACTURERS
The data from the availability study, coupled with the new legislation, delivers a critical message to manufacturers:
- Compliance is Non-Negotiable: The focus must remain on meeting the final deadlines (e.g., MDR high-risk devices by December 31, 2027, IVDR Class D devices by December 31, 2027). The high rate of discontinuation is the direct result of manufacturers assessing that the cost or complexity of compliance outweighs the commercial return, especially for niche devices.
- Risk Management is Public: Discontinuation is now a public regulatory event. Manufacturers must formalize their internal policies to ensure they can provide the mandated six-month notice, including details on the device’s availability and any substitutes.
- Use the Time Wisely: The transitional extensions for both MDR and IVDR were granted to ensure device availability. Manufacturers who have not yet secured their contracts with Notified Bodies or lodged their applications risk missing the final cut-off dates and losing EU market access.