EU MDR Annex II: Technical Documentation Structure, Section by Section
Annex II of Regulation (EU) 2017/745 defines the structure of the technical documentation every medical device manufacturer must compile. It is short — six sections…
MD Regulatory Blog
EU MDR 2017/745
EU MDR 2017/745
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ISO 13485 Design Controls: Requirements and Design History File
The ISO 13485 design control requirements are where most small and medium medical device manufacturers fail their first certification audit. Clause 7.3 of ISO 13485:2016…
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EU MDR GSPR Checklist: How to Demonstrate General Safety and Performance Requirements
Every medical device placed on the EU market must demonstrate conformity with the General Safety and Performance Requirements set out in Annex I of Regulation…
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EU MDR Post-Market Surveillance : PMS Plan, PSUR and PMCF Requirements
What EU MDR Requires for Post-Market SurveillanceThe PMS System — How It WorksThe Post-Market Surveillance Plan (PMS Plan)PMSR vs PSUR — Requirements by Device ClassThe…
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ISO 14971 Risk Management for Medical Devices: Complete Process Guide
ISO 14971 is the foundational international standard for risk management of medical devices. It specifies terminology, principles, and a comprehensive process for risk management of…
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EU MDR Clinical Evaluation Report: Requirements, Structure and Common Mistakes
The Regulatory Framework: MDR Article 61 and Annex XIVMEDDEV 2.7/1 Revision 4: The Primary Guidance DocumentThe Clinical Evaluation Process: Four StagesStage 0 — Scope DefinitionStage…
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EU MDR Technical Documentation Requirements: Complete Guide to Annex II and III
EU MDR technical documentation requirements define the full scope of evidence that every medical device manufacturer must compile, maintain, and make available to demonstrate compliance…
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EU MDR Transition Deadlines 2026, 2027 and 2028: The Complete Guide for Medical Device Manufacturers
The EU MDR transition deadlines are now in their final phase. The first hard date under the extended timeline — 26 May 2026, for Class…
