medical device directive

Notified Body in Spain Illustrates MDR Compliance Complexity

The Regulatory Affairs Professional Society (RAPS) is reporting that the Spanish Notified Body (NB)...

New Stricter EU Regulations Drafted For Medical Devices

Due to the recent Poly Implant Prothese fraud case where executives went to trial...

Software as a Medical Device – Part II

Since the 2007 amendment to the Medical Devices Directive (93/42/EC)1 aimed at clarifying its...

Software as a Medical Device – Part II

Since the 2007 amendment to the Medical Devices Directive (93/42/EC)1 aimed at clarifying its...

Updated standards list for medical devices published by EU Commission

The Commission of the European Union (EU) has issued a revised and updated list...

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EU Commission revises standards list for medical device directive

The Commission of the European Union (EU) has issued a revised and updated list...

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