MedTech Compliance Articles
Expert guides on EU MDR, Clinical Evaluation, and Literature Review strategies.
CiteMed | EU MDR & Clinical Evaluation Insights
In-depth articles and resources on EU MDR, IVDR, and clinical evaluation for regulatory affairs professionals.
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Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European [...]
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
Under the European Medical Device Regulation (EU MDR 2017/745), [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by [...]
In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices [...]