This video breaks down the essential steps to achieve CE marking under the EU MDR, from device classification and Notified Body assessment to EUDAMED registration and post-market surveillance. Learn what manufacturers must do to legally market devices in Europe’s $181.6B medtech market. Whether you're self-certifying or preparing for NB review, this is your roadmap to MDR compliance.
This video offers a comprehensive walkthrough of the EU Medical Device Regulation (MDR 2017/745) and what manufacturers must do to obtain CE marking and gain access to the European Union’s USD $181.6 billion medtech market. With the strictest regulatory framework the EU has ever implemented, the MDR governs everything from device classification and conformity assessment to post-market surveillance and vigilance. Whether you're a startup launching a Class I wearable or a multinational introducing a high-risk implantable, this video lays out the essential steps to compliance.
Topics covered in this video include:
CE marking under the MDR is mandatory for all medical devices sold in the EU and serves as proof that a device meets the region’s safety and performance requirements. Manufacturers must first determine whether their product qualifies as a medical device and then classify it using Annex VIII. Low-risk Class I devices may be self-certified, while all others require formal assessment by an EU-accredited Notified Body (NB). For these higher-risk devices, conformity assessment involves technical documentation review, quality management system (QMS) audits, and potential expert scrutiny.
Compliance starts with building an MDR-compliant QMS aligned with ISO 13485 and appointing a Person Responsible for Regulatory Compliance (PRRC). The device must meet all applicable General Safety and Performance Requirements (GSPRs), with supporting evidence included in a robust technical file. Foreign manufacturers must also appoint an Authorized Representative (AR) within the EU to act as the legal liaison with regulators and Competent Authorities.
This video also outlines the necessary EUDAMED registration steps (mandatory from Q1 2026) including registration of economic operators and individual devices. Manufacturers must draft and sign a Declaration of Conformity (DoC), which legally confirms MDR compliance and permits the CE mark to be affixed. Post-certification, obligations continue: PMS plans, vigilance reporting, PSURs, certificate renewals, and ongoing EUDAMED maintenance are all required to maintain market access.
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