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MedTech Europe: ISO 20916 Clinical performance studies using specimens from human subjects – Good study practice

ISO 20916 Clinical performance studies using specimens from human subjects – Good study practice
The International Organisation for Standardisation (ISO) published ISO standard 20916 on Clinical performance studies using specimens from human subjects – Good study practice in May 2019. The standard outlines good study practice for the planning, design, conduct and documentation of clinical performance studies that are carried out to assess the clinical performance of in-vitro diagnostic […] The post ISO 20916 Clinical performance studies using specimens from human subjects – Good study practice appeared first on MedTech Europe.
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EU UDI issuing agencies announced
The Commission Implementing Decision (EU) 2019/939 of 6 June 2019 on the issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) designated the following UDI issuing entities (listed in the Annex of the Decision) to support medical device and IVD manufacturers comply with new regulatory requirements of the MDR […] The post EU UDI issuing agencies announced appeared first on MedTech Europe.
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Implementation tools to help transitioning from Directives to Regulations
After the last meeting of the Medical Device Coordination Group, two newly approved guidance documents were published aiming at ensuring a harmonised implementation of Medical Device Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR): • MDCG 2019-7: Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a […] The post Implementation tools to help transitioning from Directives to Regulations appeared first on MedTech Europe.
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