Ressources

Bringing your SaMD to Europe: the essential steps for CE marking compliance

US SaMD manufacturer? Here are the 5 key steps to obtain CE marking and access the European market: QMS, classification, technical documentation, Notified Body and EUDAMED registration.

Maya Bouslimani
February 25, 2025
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Expanding into Europe: the importance of an authorised representative for SaMD manufacturers

Non-EU SaMD manufacturers must appoint an Authorised Representative to access the European market. Role, responsibilities and regulatory obligations under article 11 of MDR 2017/745: what you need to know.

Maya Bouslimani
February 24, 2025
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Medical software embedding AI: which rules and classifications you need to know

Diagnostic support algorithms, DTx, prescription software… How to obtain CE marking for a medical device embedding AI? Classification, compliance process and articulation with the AI Act: the complete overview.

Manon Marault
February 12, 2025
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CE marking for Digital Therapeutics (DTx): classification and regulatory pathway

Digital Therapeutics (DTx) are medical devices subject to CE marking. Classification under rule 11 of MDR 2017/745, regulatory pathway by risk class and market launch strategy: the essential guide for manufacturers.

Manon Marault
January 26, 2025
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Upgrading your digital medical device from Class I to Class IIa

Class I then Class IIa: is it possible to start with self-certification before upgrading your medical device? Classification differences, regulatory impacts and CE marking strategy to adopt.

Manon Marault
July 28, 2024
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New European regulation: Regulation (EU) 2024/1689 on AI

Regulation 2024/1689 (AI Act) imposes a new framework for artificial intelligence, with risk-based classification and a key deadline of 2 August 2027 for high-risk medical devices. Key points and steps to prepare.

Manon Marault
July 23, 2024
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Understanding the UDI system

MDR 2017/745 imposes a new traceability system: UDI. Basic UDI-DI, UDI-DI, UDI-PI… A breakdown of the different codes to know and the steps with GS1 to obtain them.

Ranya Adnane
June 14, 2024
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The 26 May 2024 deadline for medical devices

T-30 days before the 26 May 2024 deadline: manufacturers of medical devices in classes higher than I must have submitted an application to a Notified Body and brought their QMS into compliance with MDR 2017/745.

Manon Marault
May 26, 2024
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A closer look at the MDD to MDR transition period

CE marking: between transition period, overwhelmed notified bodies and timelines of 12 to 18 months, medical device manufacturers are facing a race against the clock. Key figures and deadlines to know.

Manon Marault
March 4, 2024
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Understanding the AI Act roadmap

The European AI Act imposes a new framework on medical devices embedding artificial intelligence. Timeline, manufacturer challenges and certification hurdles: what you need to know to anticipate.

Manon Marault
February 28, 2024
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The measurable cost of regulatory uncertainty

More than 40% of medical device companies face regulatory costs exceeding €500,000, and nearly half of these costs are avoidable.

Manon Marault
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