MEDDEV 2.7.1

MEDDEV 2.7.1

MEDDEV 2.7.1: clinical evaluation New Regulation on Clinical Evaluation One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer.…

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EU medical Device Regulation

EU Medical Device Regulation changes

What happened before the EU Medical Device Regulation and In vitro Diagnostic Regulation ? See what changes in EU medical Device Regulation. The existing European regulatory framework originated in the 1990s consists of three directives designed to regulate about 500,000 types of medical devices (e.g. contact lenses, breast implants, x-ray machines, pacemakers) and in-vitro diagnostic…

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South Korea regulation changes in 2018

South Korea regulation changes in 2018 The following regulatory changes are expected in 2018 in the South Korea regulation as published by the MFDS (Ministry of Food and Drug Safety): Main regulatory changes in South Korea regulation Adopt customized licensing system for advanced medical devices – ‘Special Act on Promotion of Advanced Medical Device Development…

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Innovative medical devices in Korea – forecast analysis report

Innovative medical devices in Korea – forecast analysis report The Korean MFDS published a forecast analysis report for innovative medical devices in South Korea. The link to the report is here. To help the medical device companies, Korean MFDS prepared and distributed the reports on the status and prospects of innovative medical devices(medical devices manufactured with…

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Guideline for pulse oximeters

This guideline for pulse oximeters was prepared to help the writing of the technical documentation and subsequent approval. pulse oximeters are commonly used to measure the concentration of oxygen in the blood. Main content of this guideline includes: medical equipment approval authorization process approval and technical requirement items, and examples of technical requirements. MFDS Evaluation…

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