ISO 80369: Small-Bore Connectors and Misconnection Risk
ISO 80369 exists because the Luer connector is too good at its job. A single conical fitting that lets almost any syringe join almost any…
MD Regulatory Blog
EU MDR 2017/745
EU MDR 2017/745
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ISO 15223: The Symbols Standard for Medical Device Labels
ISO 15223 is the reason a device label can say almost nothing in words and still say everything a regulator requires. Under MDR Annex I,…
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ISO 20417: The Complete Guide to the 2026 Edition
ISO 20417 is the horizontal standard that decides what has to be on a medical device label, in its instructions for use and in its…
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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…
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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
Post-market surveillance is where the EU MDR departs most sharply from the Directive it replaced. Under the MDD, PMS was a general obligation with no…
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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 Clinical Evaluation Report is the most consequential document in an EU MDR technical file, and the one Notified Bodies most often find inadequate. It…
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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…
