Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021,…
20 Nov 2025
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The…
20 Nov 2025
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The…
20 Nov 2025
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
The core PMCF templates, MDCG 2020-7 for the plan and MDCG 2020-8 for the evaluation report, are still current as of this…
20 Nov 2025
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of…
20 Nov 2025
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 products in the EU. It's that simple. CE…
20 Nov 2025
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 of and document the performance and safety of…
20 Nov 2025
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…
20 Nov 2025