A to Z of a Clinical Evaluation Report

One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that demonstrates the safety, performance, and efficacy of your dev...

EU Classifications and Rules for CE Marking

For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on their intended purpose should always be the first step. <...

What does CE Marking imply and why is it required?

Manufacturers must obtain CE marking for the products they want to sell in the European Union (EU). When a product is CE marked, it means that the product is assessed by the manufacturer and fou...

THE A-Z OF CLINICAL EVALUATION REPORT

Ever wondered if the product that you are using is safe? Ever wondered how is the safety assured? Ever wondered where do all the complaints and feedback go? A simple answer to all these is a Cli...

Comprehensive CER – A key component to CE Marking

Applying for a CE Marking or have one already?

In both the cases, CER would be created or updated per MEDDEV 2.7/1 Revision 4 (June 2016). Non compliance to this new revision of the MEDDE...