EU Classification Guidance Updated: Borderline Manual and MDCG 2021-24
The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are…
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What’s the Cost of Medical Device Approval in Europe?
Medical device approval costs in Europe range from a few thousand euros for Class I devices to over €100,000 for Class III products. The MDR has significantly increased expenses compared to the previous MDD system, with clinical evaluation requirements, notified body fees, and technical documentation demands driving costs higher. Hidden expenses like post-market surveillance, translation services, and quality system upgrades often catch manufacturers unprepared. Understanding these cost factors—from application fees and audit expenses to ongoing surveillance—helps you budget accurately and avoid financial surprises during CE marking.
EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market…
New EU Guidance on Breakthrough Devices & IVDs
In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document…
How Do I Get Approval to Sell Medical Devices in France?
Learn CE marking and ANSM registration requirements for French medical device approval success.
What Are Spain-Specific Requirements for Medical Devices?
Navigate Spain's dual medical device regulations: EU MDR plus AEMPS requirements for successful market entry.
What are the Fees for Selling Medical Devices in Europe?
Selling medical devices in Europe requires navigating complex fee structures that vary dramatically by device classification. From CE marking certification ranging €5,000-€100,000+ to annual European Authorized Representative fees and Notified Body surveillance audits, manufacturers face both substantial upfront investments and recurring compliance costs. Understanding the distinction between one-time expenses like technical file preparation and ongoing obligations such as post-market surveillance helps you budget accurately and avoid surprises like translation requirements and country-specific registrations.
How Do I Sell Medical Devices in France?
Navigate EU MDR compliance, ANSM registration, and distributor partnerships to successfully enter France's medical device market.
MDCG 2025-8 and the New Master UDI-DI Requirements
The Medical Device Coordination Group (MDCG) has published MDCG 2025-8, a comprehensive guidance document on…
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