MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof [...]
In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one [...]
Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance
Guide - MDCG endorsed documents and other guidance documents. The majority of documents on [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its [...]
Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation [...]
What Is a Legacy Device, and What Do Manufacturers Need to Know About It?
The MDR is a sweeping reform of medical device regulation in Europe that aims [...]
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device [...]
The UK MDR and The EU MDR: What Are The Differences?
UK MDR is the primary standard that mandates requirements for anyone selling medical products [...]
