MDCG 2025-10 guidance published
MDCG 2025-10 guidance published - More than data collection: PMS expectations for manufacturers The new guidance makes it clear that PMS is not a separate administrative obligation, but a key…
View of notified bodies on the MDR and IVDR review process
View of notified bodies on the MDR and IVDR review process The European Commission has published a Call for evidence from stakeholders in the healthcare industry, inviting them to share…
IVDR: Post-Market Performance Follow-Up of IVDR Devices
IVDR: Post-Market Performance Follow-Up of IVDR Devices I. Introduction The IVDR requires manufacturers to conduct performance evaluations throughout the device lifecycle to ensure that the safety and performance of the…
MDR: Clinical Evaluation in the Focus of Conformity Assessment
MDR: Clinical Evaluation in the focus of Conformity Assessment It is no exaggeration to say that the MDR has declared war on a number of anomalies by making clinical evaluation…
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What Are the responsibilities of a Site Auditor, a Product Reviewer and a Clinical Expert?
What Are the Responsibilities of a Site Auditor, a Product Reviewer and a Clinical Expert? Key Participants in the Conformity Assessment Conformity assessment for medical devices is fundamentally a manufacturer’s…
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IVDR: The Transitional Period Has Been Extended!
IVDR: The Transitional Period Has Been Extended! The transitional period for the IVDR has been extended! On July 9, 2024, the European Parliament and the Council issued a regulation that…
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MDR: The Transitional Period for Legacy Devices Has Been Extended!
MDR: The Transitional Period for Legacy Devices Has Been Extended! On March 20, 2023, the EU regulation extending the MDR transitional period came into force. The rationale for the regulation…
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The 3 Most Common Reasons for MDR Application Rejection
MDR: The 3 Most Common Reasons for MDR Application Rejection In July 2023, the European Commission published the results of its latest survey among notified bodies regarding MDR/IVDR certificates and…